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

University of Washington

Status: Completed

Conditions: Child Behavior Disorders

Treatments: Device: VillageWhere App; Device: Attention-Control Placebo App

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03065517

R44MH097349 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups, including a placebo group

VillageWhere App

Experimental group

Description:

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.

Treatment:

Device: VillageWhere App

Attention-Control Placebo App

Placebo Comparator group

Description:

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.

Treatment:

Device: Attention-Control Placebo App