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

Study Overview
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Brief Summary
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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.

Official Title
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Using Mobile Technology to Enhance MST Outcomes

Conditions
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Child Behavior Disorders

Intervention / Treatment
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* Device: VillageWhere App
* Device: Attention-Control Placebo App


Participation Criteria
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Eligibility Criteria
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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 clinically significant 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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VillageWhere App<br>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<br>* VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.<br>|
| Placebo Comparator: Attention-Control Placebo App<br>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<br>* Mobile phone app for use on both Android and iOS platforms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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). | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| Perceived Stress Scale (PSS) | Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 
| 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. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Criminal Justice, Juvenile Delinquency