ClinicalTrials.gg
CompletedNCT02670902Updated Nov 1, 2022

Intervention for Persons Leaving Residential Substance Abuse Treatment

An interventional study of Critical Time Intervention-Residential (CTI-R) and Enhanced Usual Discharge Services-Residential in Substance Use Disorders, sponsored by New York University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by New York University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.

Read the detailed description

This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.

02

Conditions studied

  • Substance Use Disorders

Keywords

  • Residential substance use treatment
  • Transition
03

In context

Substance-Related Disorders

2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.

This study's enrollment of 60 is below the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

New York University is the lead sponsor of 123 studies on the registry; 32 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.

Exclusion criteria

Exclusion Criteria:

  • Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:

    1. Anyone under the age of 18
    2. Non-English speaking individuals due to limited resources
    3. Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
    4. Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Critical Time Intervention-Residential

    CTI-R is a 9-month, assertive outreach and linkage program.

    Behavioral: Critical Time Intervention-Residential (CTI-R) · Behavioral: Enhanced Usual Discharge Services-Residential

  • Active comparator
    Enhanced Usual Discharge-Residential

    The enhanced usual discharge condition includes usual discharge services plus enhanced transition services.

    Behavioral: Enhanced Usual Discharge Services-Residential

Interventions

  • BehavioralCritical Time Intervention-Residential (CTI-R)

    CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program.

  • BehavioralEnhanced Usual Discharge Services-Residential

    The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.

06

What researchers measure

Primary outcomes

  1. Enrollment

    Proportion of participants enrolled in the study as measured by the research records

    Time frame: Baseline

  2. Change in retention

    Proportion of participants completed the study as measured by the research records

    Time frame: 3, 6, 9, and 12 months

  3. Short-term Relapse

    Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index

    Time frame: 3 months

  4. Use of aftercare services

    Proportion of participants who were linked to aftercare services (i.e. substance use treatment) at the time of discharge as measured by the Treatment Service Review (TSR)

    Time frame: 3 months

  5. Housing

    Proportion of participants housed at the time of discharge

    Time frame: 3 months

Secondary outcomes

  1. Short-term Social Support

    Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey

    Time frame: 3 months

  2. Short-term Self-Efficacy

    Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."

    Time frame: 3 months

  3. Short-term Mental Health

    Level of mental health severity as measured by the Brief Symptom Inventory

    Time frame: 3 months

  4. Change in Relapse

    Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index

    Time frame: 3, 6, and 9 months

  5. Long-term Relapse

    Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index

    Time frame: 12 months

  6. Change in Social Support

    Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey

    Time frame: 3, 6, and 9 months

  7. Long-term Social Support

    Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey

    Time frame: 12 months

  8. Change in Self-Efficacy

    Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."

    Time frame: 3, 6, and 9 months

  9. Long-term Self-Efficacy

    Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."

    Time frame: 12 months

  10. Change in Mental Health

    Level of mental health severity as measured by the Brief Symptom Inventory

    Time frame: 3, 6, and 9 months

  11. Long-term Mental Health

    Level of mental health severity as measured by the Brief Symptom Inventory

    Time frame: 12 months

07

Study locations

1 site
  • New York University
    New York, New York 10003, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in May 2020, 36 months.

Of 812 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 36 months is close to that.

Counting every sponsor, half of 855 studies reached it within 32 months; a quarter within 16 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2016
First posted
Feb 2, 2016
StartActual
May 1, 2017
Primary completionActual
May 1, 2020
CompletionActual
Dec 31, 2020
Last update
Nov 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02670902
Responsible party
Sponsor
First posted
Feb 2, 2016
Start date
May 1, 2017
Primary completion
May 1, 2020
Completion
Dec 31, 2020
Last update
Nov 1, 2022

Study contacts

Jennifer I Manuel, PhD
principal investigator · New York University

Oversight

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

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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