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

Child Behavior Disorders Clinical Trial

— VillageWhere  

Official title:

Using Mobile Technology to Enhance MST Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065517
• Other study ID #: R44MH097349
• Secondary ID: R44MH097349
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2022
• Source: Evidence-Based Practice Institute, Seattle, WA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Disorders
• Mental Disorders

Intervention

Device:
• VillageWhere App
VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.
• Attention-Control Placebo App
Mobile phone app for use on both Android and iOS platforms.

Locations

Country	Name	City	State
United States	Evidence-Based Practice Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Evidence-Based Practice Institute, Seattle, WA	National Institute of Mental Health (NIMH), University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).