CClinicalTrials.gg
CompletedNCT02946255Updated Mar 19, 2024Results posted

Testing the Effectiveness of The Welcome Basket Intervention

An interventional study of Welcome Basket (WB) and Welcome Basket Brief (WBbr) in Psychosis, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. It involves Peer Support Workers connecting with and supporting hospitalized individuals in the days before discharge and again in the community in the first month immediately following discharge. The investigators will compare the outcomes of discharge from hospital as usual with the full version of the welcome basket and a preliminary test of an abbreviated 2 visit version of the intervention.

Read the detailed description

Discharge from hospital has been highlighted as a critical time in the care of individuals with mental illness. The peak period of risk for readmission for individuals with severe mental illness is in the first month and the highest risk for post-discharge suicide is within the first 2 weeks with discontinuity of contact with providers highlighted as a key risk factor. One half of individuals with schizophrenia miss their first-scheduled outpatient appointment following discharge and this time is a key period of risk for medication non-compliance. Common problems that occur at the time of discharge from psychiatric care settings include poor communication between inpatient and outpatient providers and inadequate involvement and support of families. The research literature on effective practices linked with discharge is strikingly sparse given the evidence that this is a period of heightened risk.

The investigators hypothesize that the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia or bipolar disorder with psychotic features compared to treatment as usual. Investigators will also explore the outcomes of an abbreviated, 2-visit version of the intervention. This study will employ a randomized, controlled trial design. Inpatient clients with a diagnosis of schizophrenia spectrum mental illness or bipolar disorder with psychotic features will be randomized with a 2:2:1 ratio to: treatment as usual, the full welcome basket intervention, and the abbreviated intervention. Measures will include re-hospitalization, symptomatology, quality of life, and community functioning. Assessments at baseline, 4 weeks post-discharge, and 6 months post-discharge will facilitate studies of relative effectiveness and sustainment of gains. This design will facilitate an examination of both overall outcomes as well as some preliminary dismantling of mechanisms of action.

02

Conditions studied

  • Psychosis

Keywords

  • Psychosis
  • Psychosis NOS
  • Schizophrenia
  • Hospital discharge
  • Inpatient psychiatry
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's enrollment of 110 is above the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness or bipolar disorder with psychotic features confirmed by Module B (psychotic symptoms) of the Structured Clinical Interview for DSM-5 (SCID-5) (First, William, Karg, \& Spitzer, 2015). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for close to or more than 2 weeks. This timeframe is guided by the rationale and experience indicating that an overly brief period of hospitalization circumscribes the relevance of the intervention.
  2. Participants will be returning to places of residence in the Greater Toronto Area (catchment of CAMH) or can travel to the GTA if they will reside outside the catchment area.
  3. Participants must have been referred to outpatient case management.
  4. Proposed housing arrangements must be stable and conducive to the intervention. If homelessness or emergency shelter residence appears likely, or boarding home policy precludes any external staff from entering the premises, such individuals will be excluded.
  5. Proficiency in English.

Exclusion criteria

Exclusion criteria:

  1. Do not meet the above criteria.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Welcome Basket Brief (WBbr)

    The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.

    Behavioral: Welcome Basket Brief (WBbr)

  • Experimental
    Welcome Basket (WB)

    Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.

    Behavioral: Welcome Basket (WB)

  • Active comparator
    Treatment As Usual

    Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.

    Behavioral: Treatment As Usual

Interventions

  • BehavioralWelcome Basket (WB)

    Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a "welcome basket" is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.

  • BehavioralWelcome Basket Brief (WBbr)

    The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.

  • BehavioralTreatment As Usual

    Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.

06

What researchers measure

Primary outcomes

  1. Multnomah Community Ability Scale - Participant Interview Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: Baseline

  2. Multnomah Community Ability Scale - Participant Interview Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: 4 Week Follow-Up

  3. Multnomah Community Ability Scale - Participant Interview Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: 6 Month Follow-Up

  4. Multnomah Community Ability Scale - Clinician Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: Baseline

  5. Multnomah Community Ability Scale - Clinician Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: 4 Week Follow-Up

  6. Multnomah Community Ability Scale - Clinician Based

    Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

    Time frame: 6 Month Follow-Up

Secondary outcomes

  1. Hospitalizations and Emergency Room Visits

    The percentage of participants that were re-hospitalized or visited the emergency room during the study were captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.

    Time frame: Baseline to 6 Month Follow-Up

  2. The Satisfaction With Life Scale

    Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

    Time frame: 4 Week Follow-Up

  3. The Satisfaction With Life Scale

    Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

    Time frame: 6 Month Follow-Up

  4. Social Support Survey

    Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

    Time frame: Baseline

  5. Social Support Survey

    Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

    Time frame: 4 Week Follow-Up

  6. Social Support Survey

    Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

    Time frame: 6 Month Follow-Up

  7. Brief Symptom Inventory

    Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

    Time frame: Baseline

  8. Brief Symptom Inventory

    Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

    Time frame: 4 Week Follow-Up

  9. Brief Symptom Inventory

    Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

    Time frame: 6 Month Follow-Up

  10. Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

    The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

    Time frame: Baseline

  11. Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

    The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

    Time frame: 4 Week Follow-Up

  12. Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

    The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

    Time frame: 6 Month Follow-Up

  13. Personal Recovery Outcome Measure

    The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

    Time frame: Baseline

  14. Personal Recovery Outcome Measure

    The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

    Time frame: 4 Week Follow-Up

  15. Personal Recovery Outcome Measure

    The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

    Time frame: 6 Month Follow-Up

  16. Community Integration Scale

    Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

    Time frame: 4 Week Follow-Up

  17. Community Integration Scale

    Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

    Time frame: 6 Month Follow-Up

07

Results

Posted Mar 19, 2024
Limitations and caveats
The metrics employed in this study may have lacked sufficient sensitivity given the short time frame of this study. Other limitations of this study included its deployment at a single clinical site, a limited sample size, a relatively short follow-up period, and un-blinded participants. Diversity in participant clinical profiles and life circumstances may have also influenced these findings with a recruitment strategy that included both early intervention and chronic care units.

Participant flow

Participant flow — Overall Study
MilestoneWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Started234146
4 week follow-up163333
Completed163127
Not completed71019

Outcome measures

PrimaryMultnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
Baseline
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Participant Interview Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Participant Interview Based65.45 ± 15.6767.83 ± 7.6764.66 ± 11.81
PrimaryMultnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
4 Week Follow-Up
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Participant Interview Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Participant Interview Based70.67 ± 2.0871.04 ± 1.7071.49 ± 1.20
PrimaryMultnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
6 Month Follow-Up
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Participant Interview Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Participant Interview Based72.03 ± 2.4368.65 ± 2.0970.41 ± 1.6
PrimaryMultnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
Baseline
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Clinician Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Clinician Based63.05 ± 8.7660.20 ± 14.1460.11 ± 15.73
PrimaryMultnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
4 Week Follow-Up
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Clinician Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Clinician Based60.15 ± 3.5464.53 ± 2.8965.99 ± 1.9
PrimaryMultnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame:
6 Month Follow-Up
Reported as:
Mean · Total Score
Multnomah Community Ability Scale - Clinician Based
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Multnomah Community Ability Scale - Clinician Based66.64 ± 3.6559.84 ± 3.0765.97 ± 2.4
SecondaryHospitalizations and Emergency Room Visits

The percentage of participants that were re-hospitalized or visited the emergency room during the study were captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.

Time frame:
Baseline to 6 Month Follow-Up
Reported as:
Number · percentage of participants in arm
Hospitalizations and Emergency Room Visits
percentage of participants in armWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Hospitalizations13.612.26.8
Emergency Room Visits13.67.39.1
SecondaryThe Satisfaction With Life Scale

Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

Time frame:
4 Week Follow-Up
Reported as:
Mean · Subscale score
The Satisfaction With Life Scale
Subscale scoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Living Situation Subscale2.31 ± 0.302.63 ± 0.242.70 ± 0.02
Social Relationships Subscale2.19 ± 0.282.14 ± 0.222.14 ± 0.15
Work Subscale1.94 ± 0.371.78 ± 0.301.74 ± 0.14
Self and Present Life Subscale2.44 ± 0.272.18 ± 0.222.36 ± 0.07
SecondaryThe Satisfaction With Life Scale

Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

Time frame:
6 Month Follow-Up
Reported as:
Mean · Subscale score
The Satisfaction With Life Scale
Subscale scoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Living Situation Subscale2.66 ± 0.352.67 ± 0.292.23 ± 0.08
Social Relationships Subscale2.29 ± 0.332.22 ± 0.271.97 ± 0.04
Work Subscale1.87 ± 0.341.71 ± 0.281.63 ± 0.15
Self and Present Life Subscale2.45 ± 0.312.22 ± 0.262.28 ± 0.05
SecondarySocial Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame:
Baseline
Reported as:
Mean · Total Score
Social Support Survey
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Social Support Survey65.59 ± 20.6964.07 ± 21.8557.44 ± 18.58
SecondarySocial Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame:
4 Week Follow-Up
Reported as:
Mean · Total Score
Social Support Survey
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Social Support Survey67.68 ± 4.9960.54 ± 4.2364.11 ± 2.9
SecondarySocial Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame:
6 Month Follow-Up
Reported as:
Mean · Total Score
Social Support Survey
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Social Support Survey68.66 ± 6.2463.54 ± 5.4167.50 ± 3.9
SecondaryBrief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame:
Baseline
Reported as:
Mean · Global Severity Index
Brief Symptom Inventory
Global Severity IndexWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Brief Symptom Inventory67.05 ± 49.3962.41 ± 42.5656.93 ± 38.19
SecondaryBrief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame:
4 Week Follow-Up
Reported as:
Mean · Global Severity Index
Brief Symptom Inventory
Global Severity IndexWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Brief Symptom Inventory0.94 ± 0.160.77 ± 0.120.88 ± 0.11
SecondaryBrief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame:
6 Month Follow-Up
Reported as:
Mean · Global Severity Index
Brief Symptom Inventory
Global Severity IndexWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Brief Symptom Inventory0.83 ± 0.220.93 ± 0.181.03 ± 0.17
SecondaryGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame:
Baseline
Reported as:
Mean · Subscale score
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Subscale scoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.23 ± 1.771.05 ± 1.471.88 ± 2.01
SecondaryGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame:
4 Week Follow-Up
Reported as:
Mean · Subscale score
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Subscale scoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.20 ± 0.371.25 ± 0.311.35 ± 0.99
SecondaryGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame:
6 Month Follow-Up
Reported as:
Mean · Subscale score
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale
Subscale scoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.24 ± 0.441.31 ± 0.371.51 ± 1.3
SecondaryPersonal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame:
Baseline
Reported as:
Mean · Total Score
Personal Recovery Outcome Measure
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Personal Recovery Outcome Measure26.64 ± 8.4424.20 ± 7.9725.23 ± 8.63
SecondaryPersonal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame:
4 Week Follow-Up
Reported as:
Mean · Total Score
Personal Recovery Outcome Measure
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Personal Recovery Outcome Measure6.09 ± 0.446.48 ± 0.376.29 ± 1.5
SecondaryPersonal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame:
6 Month Follow-Up
Reported as:
Mean · Total Score
Personal Recovery Outcome Measure
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Personal Recovery Outcome Measure6.61 ± 0.496.11 ± 0.426.22 ± 1.5
SecondaryCommunity Integration Scale

Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

Time frame:
4 Week Follow-Up
Reported as:
Mean · Total Score
Community Integration Scale
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Community Integration Scale1.44 ± 0.121.45 ± 0.101.31 ± 0.75
SecondaryCommunity Integration Scale

Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

Time frame:
6 Month Follow-Up
Reported as:
Mean · Total Score
Community Integration Scale
Total ScoreWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Community Integration Scale1.39 ± 0.161.32 ± 0.131.49 ± 0.99

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Welcome Basket Brief (WBbr)0/22 (0%)10/22 (45.5%)0/22 (0%)
Welcome Basket (WB)2/41 (4.9%)13/41 (31.7%)0/41 (0%)
Treatment As Usual0/44 (0%)11/44 (25%)0/44 (0%)
Most frequent serious events
Most frequent serious events
EventWelcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As Usual
Hospitalizations (Inpatient)Psychiatric disorders10/2213/4111/44

Baseline characteristics

Age, Continuous
Age, Continuous(years)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Mean32.09 ± 15.7936.44 ± 15.0834.14 ± 14.2034.60 ± 14.82
Sex: Female, Male
Sex: Female, Male(Participants)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Female6191641
Male16222866
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Hispanic or Latino1214
Not Hispanic or Latino17394197
Unknown or Not Reported4026
Education
Education(Participants)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
High school not completed313723
High school completed6121129
Post-secondary completed49821
Post-secondary attended861832
Unknown1102
Not in a Relationship
Not in a Relationship(Participants)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Count of participants18353790
Employment
Employment(Participants)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Employed1359
Unemployed13272868
Other Work Status8111029
Unknown0011
Number of Hospitalizations in the past year
Number of Hospitalizations in the past year(Hospitalizations)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Mean1.91 ± 1.481.54 ± 1.001.91 ± 1.431.76 ± 1.29
Number of arrests in the past year
Number of arrests in the past year(Arrests)Welcome Basket Brief (WBbr)Welcome Basket (WB)Treatment As UsualTotal
Number15511

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5T 1R8, Canada
09

References and documents

Publications

  • Barker S, Barron N, McFarland BH, Bigelow DA. A community ability scale for chronically mentally ill consumers: Part I. Reliability and validity. Community Ment Health J. 1994 Aug;30(4):363-83. doi: 10.1007/BF02207489. PubMed 7956112 ↗
  • Lee, K., Brekke, J., Yamada, A., & Chou, C. (2010). Longitudinal invariance of the satisfaction with life scale for individuals with schizophrenia. Research on Social Work Practice, 20(2), 234-241.
  • Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.
  • Barbic, S., Kidd, SA, Backman, C., MacEwan, W.. Honer, W., & McKenzie, K. (2016). The development and testing of the Personal Recovery Outcome Measure (PROM) [in preparation].
  • Stergiopoulos V, Gozdzik A, Misir V, Skosireva A, Connelly J, Sarang A, Whisler A, Hwang SW, O'Campo P, McKenzie K. Effectiveness of Housing First with Intensive Case Management in an Ethnically Diverse Sample of Homeless Adults with Mental Illness: A Randomized Controlled Trial. PLoS One. 2015 Jul 15;10(7):e0130281. doi: 10.1371/journal.pone.0130281. eCollection 2015. PubMed 26176621 ↗
  • First MB, William JBW, Karg RS, Spitzer RL: Structured Clinical Interview for DSM-5-Research Version (SCID-5 for DSM-5, Research Version; SCRID-5-RV). Arlington,VA, American Psychiatric-Association, 2015.
  • Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b. PubMed 2035047 ↗
  • Dennis ML, Chan YF, Funk RR. Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing and substance use disorders and crime/violence problems among adolescents and adults. Am J Addict. 2006;15 Suppl 1(Suppl 1):80-91. doi: 10.1080/10550490601006055. PubMed 17182423 ↗
  • Birchwood M, Smith J, Cochrane R, Wetton S, Copestake S. The Social Functioning Scale. The development and validation of a new scale of social adjustment for use in family intervention programmes with schizophrenic patients. Br J Psychiatry. 1990 Dec;157:853-9. doi: 10.1192/bjp.157.6.853. PubMed 2289094 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 15, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02946255
Lead sponsor
Centre for Addiction and Mental Health
Responsible party
Sean Kidd (Independent Clinician Scientist, Centre for Addiction and Mental Health) — Principal investigator
First posted
Oct 27, 2016
Start date
May 16, 2017
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019
Results posted
Mar 19, 2024
Last update
Mar 19, 2024

Study contacts

Sean A Kidd, PhD
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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