ClinicalTrials.gg
CompletedNCT03065517VillageWhereUpdated Jun 2, 2022Results posted

VillageWhere: Innovative Mobile Technology for Youth With Conduct Disorder and Their Parents

An interventional study of VillageWhere App and Attention-Control Placebo App in Child Behavior Disorders, sponsored by Evidence-Based Practice Institute, Seattle, WA. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Evidence-Based Practice Institute, Seattle, WA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate, and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key treatment targets of evidence-based treatments for youth with conduct disorders: clear parental expectations, parental monitoring, discipline consistency, and parental support, while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors. When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere could help reduce treatment length and cost. When provided in non-evidence-based clinical settings, VillageWhere may increase access to state-of-the-art clinical techniques to those who might not otherwise receive them. Investigators will conduct usability and acceptability tests of new features with target-end-users (youth and their parents) and key stakeholders (i.e., probation officers, clinic administrators). Once usability and acceptability is achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing VillageWhere to an attention-control (placebo) mobile app. We expect that across four time points, VillageWhere use will result in greater improvements in parent management practices and youth autonomy support, parent-youth communication and connectedness, youth intrinsic motivation for positive behavior, and youth conduct problems than the placebo. The RCT will occur with 100 parent-youth dyads recruited from various treatment and probation settings, and represent clinically-significant conduct-problems of various clinically-significant severity levels.

02

Conditions studied

  • Child Behavior Disorders

Keywords

  • Criminal Justice
  • Juvenile Delinquency
03

In context

Child Behavior Disorders

35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.

This study's enrollment of 226 is above the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.

Browse Child Behavior Disorders studies →

Lead sponsor

Evidence-Based Practice Institute, Seattle, WA is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

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

04

Who can participate

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

Eligibility criteria

Parent Inclusion Criteria:

  • English speaking
  • owns an Android or iPhone-based smartphone with a data plan, is the primary user of the phone, and uses it on a daily basis
  • primary caregiver and has legal guardianship (custody) of a youth aged 13-18 with conduct disorder.

Parent Exclusion Criteria:

  • has an open case with child protective services
  • does not have legal custody of the youth
  • participated in Phase I project and/or the Phase II formative evaluation

Youth Inclusion Criteria:

  • English speaking
  • possesses and is the primary user of an Android or iPhone-based smartphone with a data plan
  • resides in the same household as the linked parent participant at least five days a week
  • actively (past two weeks) engaging in conduct-problem behaviors Note: Youth who have "stepped down" from a residential treatment or juvenile justice facility in the past month but may not have exhibited conduct problem behavior within the past 2 weeks will also be eligible, provided other criteria are met.

Youth Exclusion Criteria:

  • resides with a secondary caregiver 3 or more days each week
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

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

Study arms

  • Experimental
    VillageWhere App

    Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. The app is designed to be used several times throughout each day.

    Device: VillageWhere App

  • Placebo comparator
    Attention-Control Placebo App

    Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial.

    Device: Attention-Control Placebo App

Interventions

  • DeviceVillageWhere App

    VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.

  • DeviceAttention-Control Placebo App

    Mobile phone app for use on both Android and iOS platforms.

06

What researchers measure

Primary outcomes

  1. Child Behavior Checklist (CBCL)

    Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  2. Youth Self-Report (YSR)

    Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  3. Self-Report of Delinquent Behavior Scale

    Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  4. GAIN Substance Frequency Scale

    The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  5. Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)

    Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35).

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  6. Perceived Autonomy Support (PAS)

    Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  7. Perceived Stress Scale (PSS)

    Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  8. Parent Locus of Control Scale

    Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

  9. Loeber Parenting Scale

    Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency.

    Time frame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

07

Results

Posted Jun 2, 2022

Participant flow

Participant flow — Overall Study
MilestoneVillageWhere AppAttention-Control Placebo App
Started110106
Completed8490
Not completed2616

Outcome measures

PrimaryChild Behavior Checklist (CBCL)

Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Child Behavior Checklist (CBCL)
score on a scaleVillageWhere AppAttention-Control Placebo App
Rule-Breaking Time 110.73 ± 5.8611.45 ± 5.51
Rule-Breaking Time 27.88 ± 5.507.49 ± 5.19
Rule-Breaking Time 36.98 ± 5.437.31 ± 5.90
Rule-Breaking Time 47.12 ± 5.956.69 ± 6.29
Aggressive Behavior Time 119.31 ± 8.2220.53 ± 7.80
Aggressive Behavior Time 214.14 ± 6.4313.53 ± 7.84
Aggressive Behavior Time 311.93 ± 7.4012.89 ± 7.50
Aggressive Behavior Time 410.93 ± 8.2312.70 ± 8.48
PrimaryYouth Self-Report (YSR)

Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Youth Self-Report (YSR)
score on a scaleVillageWhere AppAttention-Control Placebo App
Rule-Breaking Time 111.07 ± 5.6610.33 ± 4.87
Rule-Breaking Time 29.41 ± 4.388.40 ± 4.34
Rule-Breaking Time 39.50 ± 5.417.02 ± 3.38
Rule-Breaking Time 49.70 ± 5.387.07 ± 4.71
Aggressive Behavior Time 116.22 ± 7.5015.25 ± 7.05
Aggressive Behavior Time 213.88 ± 6.5411.86 ± 5.79
Aggressive Behavior Time 312.08 ± 6.609.67 ± 5.29
Aggressive Behavior Time 411.93 ± 8.4010.51 ± 5.86
PrimarySelf-Report of Delinquent Behavior Scale

Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · Occurrences
Self-Report of Delinquent Behavior Scale
OccurrencesVillageWhere AppAttention-Control Placebo App
General Delinquency Time 116.91 ± 64.417.96 ± 14.0
General Delinquency Time 29.03 ± 15.804.29 ± 10.14
General Delinquency Time 33.74 ± 5.873.98 ± 10.12
General Delinquency Time 42.97 ± 4.733.32 ± 5.52
Status Offenses Time 13.04 ± 11.132.24 ± 3.97
Status Offenses Time 2.9 ± 1.66.67 ± 1.28
Status Offenses Time 30.74 ± 1.741.04 ± 2.25
Status Offenses Time 4.73 ± 1.911.15 ± 2.74
School Delinquency Time 16.24 ± 21.563.41 ± 5.71
School Delinquency Time 25.18 ± 10.831.8 ± 4.72
School Delinquency Time 31.72 ± 3.621.64 ± 3.61
School Delinquency Time 41.41 ± 2.801.39 ± 2.87
Minor Theft Time 10 ± 00 ± 0
Minor Theft Time 20 ± 00 ± 0
Minor Theft Time 30 ± 00 ± 0
Minor Theft Time 40 ± 00 ± 0
Robbery Time 10 ± 00 ± 0
Robbery Time 20 ± 00 ± 0
Robbery Time 30 ± 00 ± 0
Robbery Time 40 ± 00 ± 0
PrimaryGAIN Substance Frequency Scale

The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · Days
GAIN Substance Frequency Scale
DaysVillageWhere AppAttention-Control Placebo App
Alcohol Days Time 1.76 ± 2.227.48 ± 1.488
Alcohol Days Time 2.15 ± .573.00 ± .00
Alcohol Days Time 3.30 ± .791.23 ± .782
Alcohol Days Time 4.25 ± .776.12 ± .640
Drunk Days Time 1.51 ± 1.999.17 ± .734
Drunk Days Time 2.00 ± .00.00 ± .00
Drunk Days Time 3.18 ± .594.16 ± .531
Drunk Days Time 4.05 ± .316.34 ± 1.353
Marijuana Days Time 11.63 ± 3.8081.50 ± 4.152
Marijuana Days Time 2.54 ± 1.9511.13 ± 3.307
Marijuana Days Time 31.25 ± 2.9761.47 ± 3.832
Marijuana Days Time 4.80 ± 2.5441.12 ± 3.716
PrimaryIntrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)

Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35).

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)
score on a scaleVillageWhere AppAttention-Control Placebo App
Interest/Enjoyment Time 118.54 ± 7.7122.27 ± 9.18
Interest/Enjoyment Time 220.68 ± 7.0024.00 ± 6.80
Interest/Enjoyment Time 321.60 ± 8.9624.21 ± 10.62
Interest/Enjoyment Time 422.74 ± 6.2023.71 ± 8.31
Perceived Competence Time 124.20 ± 9.6423.90 ± 8.78
Perceived Competence Time 225.32 ± 6.2025.69 ± 7.43
Perceived Competence Time 323.88 ± 7.2127.38 ± 8.66
Perceived Competence Time 427.66 ± 6.9526.76 ± 8.71
Value/Usefulness Time 127.91 ± 12.0632.40 ± 11.92
Value/Usefulness Time 228.80 ± 8.7431.96 ± 9.90
Value/Usefulness Time 327.23 ± 10.3031.88 ± 11.27
Value/Usefulness Time 430.05 ± 9.5531.95 ± 10.05
Effort/Importance Time 119.15 ± 4.9320.19 ± 4.91
Effort/Importance Time 218.95 ± 3.7121.56 ± 5.01
Effort/Importance Time 319.48 ± 4.6021.81 ± 4.61
Effort/Importance Time 419.68 ± 3.7620.39 ± 3.91
PrimaryPerceived Autonomy Support (PAS)

Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Perceived Autonomy Support (PAS)
score on a scaleVillageWhere AppAttention-Control Placebo App
Parent Autonomy Time 115.20 ± 3.0715.23 ± 3.17
Parent Autonomy Time 215.33 ± 2.6715.71 ± 2.87
Parent Autonomy Time 315.46 ± 2.9915.98 ± 2.90
Parent Autonomy Time 416.20 ± 2.8415.98 ± 3.30
Parent Chaos Time 18.20 ± 2.597.91 ± 2.43
Parent Chaos Time 27.83 ± 2.618.24 ± 3.61
Parent Chaos Time 38.10 ± 2.547.76 ± 3.08
Parent Chaos Time 47.22 ± 2.047.91 ± 3.83
Parent Coercion Time 113.22 ± 3.6312.81 ± 3.83
Parent Coercion Time 212.00 ± 3.3811.78 ± 3.62
Parent Coercion Time 312.00 ± 3.2211.62 ± 3.77
Parent Coercion Time 411.46 ± 3.4410.89 ± 3.94
Parent Structure Time 116.35 ± 2.7016.17 ± 3.37
Parent Structure Time 216.17 ± 2.6816.24 ± 2.91
Parent Structure Time 316.85 ± 2.4717.11 ± 2.96
Parent Structure Time 417.46 ± 2.6516.80 ± 3.40
Youth Autonomy Time 19.48 ± 3.2510.48 ± 3.37
Youth Autonomy Time 29.46 ± 2.659.98 ± 3.49
Youth Autonomy Time 39.60 ± 3.1210.47 ± 2.82
Youth Autonomy Time 49.69 ± 3.0510.78 ± 3.31
Youth Chaos Time 18.11 ± 3.158.52 ± 2.94
Youth Chaos Time 28.10 ± 2.968.42 ± 2.84
Youth Chaos Time 38.23 ± 3.037.67 ± 2.96
Youth Chaos Time 48.30 ± 3.208.24 ± 3.35
Youth Coercion Time 19.93 ± 2.5210.10 ± 2.54
Youth Coercion Time 29.56 ± 2.619.58 ± 2.48
Youth Coercion Time 39.65 ± 2.329.30 ± 2.44
Youth Coercion Time 49.46 ± 2.769.39 ± 2.65
Youth Structure Time 110.46 ± 3.3311.35 ± 3.17
Youth Structure Time 210.02 ± 3.0810.44 ± 3.33
Youth Structure Time 310.05 ± 3.1010.67 ± 3.15
Youth Structure Time 49.83 ± 3.2010.37 ± 3.37
PrimaryPerceived Stress Scale (PSS)

Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Perceived Stress Scale (PSS)
score on a scaleVillageWhere AppAttention-Control Placebo App
Time 122.06 ± 7.2920.74 ± 5.34
Time 218.83 ± 5.5619.62 ± 5.99
Time 318.61 ± 7.7018.56 ± 6.51
Time 416.68 ± 8.0617.45 ± 5.70
PrimaryParent Locus of Control Scale

Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Parent Locus of Control Scale
score on a scaleVillageWhere AppAttention-Control Placebo App
Helpless Time 124.80 ± 5.4024.77 ± 5.37
Helpless Time 222.67 ± 4.3022.71 ± 4.98
Helpless Time 322.73 ± 4.3122.40 ± 6.15
Helpless Time 421.29 ± 5.2221.14 ± 5.33
Out of Control Time 132.84 ± 7.8534.23 ± 7.13
Out of Control Time 231.31 ± 6.5630.53 ± 7.95
Out of Control Time 329.78 ± 6.6029.33 ± 9.26
Out of Control Time 427.49 ± 8.0027.93 ± 8.97
PrimaryLoeber Parenting Scale

Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency.

Time frame:
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Reported as:
Mean · score on a scale
Loeber Parenting Scale
score on a scaleVillageWhere AppAttention-Control Placebo App
Supervision Time 126.33 ± 3.0825.53 ± 3.69
Supervision Time 221.98 ± 1.7022.04 ± 2.14
Supervision Time 322.00 ± 1.9122.53 ± 2.14
Supervision Time 422.44 ± 1.8722.23 ± 2.26
Inconsistent Discipline Time 18.40 ± 2.028.43 ± 2.27
Inconsistent Discipline Time 27.50 ± 1.857.80 ± 2.16
Inconsistent Discipline Time 37.71 ± 2.007.98 ± 2.37
Inconsistent Discipline Time 47.02 ± 1.807.82 ± 2.34
Reward Use Time 121.09 ± 2.4721.19 ± 3.43
Reward Use Time 221.50 ± 2.8121.87 ± 3.00
Reward Use Time 321.90 ± 2.5321.87 ± 3.14
Reward Use Time 422.22 ± 2.5821.68 ± 2.77
Discipline Effectiveness Time 15.94 ± 1.865.77 ± 1.90
Discipline Effectiveness Time 26.60 ± 1.716.69 ± 2.16
Discipline Effectiveness Time 36.73 ± 1.636.93 ± 2.19
Discipline Effectiveness Time 47.22 ± 1.847.23 ± 2.21

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VillageWhere App0/110 (0%)0/110 (0%)0/110 (0%)
Attention-Control Placebo App0/106 (0%)0/106 (0%)0/106 (0%)

Baseline characteristics

55 and 53 are the number of parent/youth dyads assigned to each condition.

Age, Categorical
Age, Categorical(Participants)VillageWhere AppAttention-Control Placebo AppTotal
<=18 years5051101
Between 18 and 65 years000
>=65 years000
Age, Categorical
Age, Categorical(Participants)VillageWhere AppAttention-Control Placebo AppTotal
<=18 years101
Between 18 and 65 years5452106
>=65 years011
Sex: Female, Male
Sex: Female, Male(Participants)VillageWhere AppAttention-Control Placebo AppTotal
Female252348
Male293059
Sex: Female, Male
Sex: Female, Male(Participants)VillageWhere AppAttention-Control Placebo AppTotal
Female4952101
Male617
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)VillageWhere AppAttention-Control Placebo AppTotal
Race — More than One Race or Other628
Race — American Indian or Alaskan Native213
Race — Asian112
Race — Black8917
Race — White384078
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)VillageWhere AppAttention-Control Placebo AppTotal
Race — More than One Race or Other10616
Race — American Indian or Alaskan Native213
Race — Asian011
Race — Black101020
Race — White323567
Region of Enrollment
Region of Enrollment(participants)VillageWhere AppAttention-Control Placebo AppTotal
United States5553108
Region of Enrollment
Region of Enrollment(participants)VillageWhere AppAttention-Control Placebo AppTotal
United States5553108

9 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Evidence-Based Practice Institute
    Seattle, Washington 98144, United States
09

References and documents

Publications

  • Schaeffer CM, Dimeff LA, Koerner K, Chung J, Kelley-Brimer A, Kako N, Ilac M, Tuerk E, Carroll D, Beadnell B. A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):52-66. doi: 10.1080/15374416.2022.2070851. Epub 2022 May 31. PubMed 35640058 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03065517
Lead sponsor
Evidence-Based Practice Institute, Seattle, WA
Responsible party
Sponsor
First posted
Feb 28, 2017
Start date
Jul 16, 2018
Primary completion
Feb 28, 2020
Completion
Feb 28, 2020
Results posted
Jun 2, 2022
Last update
Jun 2, 2022

Study contacts

Linda Dimeff, PhD
principal investigator · Evidence-Based Practice Institute
Cindy Schaeffer, PhD
principal investigator · University of Maryland, Baltimore

Oversight

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

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