Clinical trial NCT03065517: VillageWhere: Innovative Mobile Technology for Youth With Conduct Disorder and Their Parents
Official title: Using Mobile Technology to Enhance MST Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Disorders
Keywords: Criminal Justice
Juvenile Delinquency
Lead sponsor: Evidence-Based Practice Institute, Seattle, WA
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Maryland, Baltimore
First posted: 2017-02-28
Enrollment: 226
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 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

Primary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Youth Self-Report (YSR)
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Self-Report of Delinquent Behavior Scale
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: GAIN Substance Frequency Scale
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Perceived Autonomy Support (PAS)
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Parent Locus of Control Scale
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
measure: Loeber Parenting Scale
timeFrame: Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Evidence-Based Practice Institute
state: Washington
Study officials:
affiliation: Evidence-Based Practice Institute
name: Linda Dimeff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Cindy Schaeffer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.