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Trial record 8 of 37 for:    Recruiting, Not yet recruiting, Available Studies | "Conduct Disorder"

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

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ClinicalTrials.gov Identifier: NCT03065517
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Maryland
Information provided by (Responsible Party):
Evidence-Based Practice Institute, Seattle, WA

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.

Condition or disease Intervention/treatment Phase
Child Behavior Disorders Device: VillageWhere App Device: Attention-Control Placebo App Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Mobile Technology to Enhance MST Outcomes
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
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 16 week trial. The app is designed to be used several times throughout each day.
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.

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 16 week trial.
Device: Attention-Control Placebo App
Mobile phone app for use on both Android and iOS platforms.




Primary Outcome Measures :
  1. Change in Child Behavior Checklist (CBCL) [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors

  2. Change in Youth Self-Report (YSR) [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors

  3. Change in Self-Report of Delinquent Behavior Scale [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses youth delinquent behaviors

  4. Change in GAIN Substance Frequency Scale [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses youth alcohol and substance use

  5. Change in Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS) [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses youth intrinsic motivation for prosocial behaviors

  6. Change in Perceived Autonomy Support (PAS) [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses youth perceived autonomy-supportive and controlling parent behaviors

  7. Change in Perceived Stress Scale (PSS) [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses parent perception of life stress

  8. Change in Parent Locus of Control scale [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses parent sense of control/efficacy and supervision of youth

  9. Change in Loeber Parenting Scale [ Time Frame: baseline (time 1), 1-4 weeks (time 2), 5-8 weeks (time 3), and 9-16 weeks (time 4) ]
    Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065517


Contacts
Contact: Research Team 206-455-7934 ext 83 research@ebpi.org

Locations
United States, Washington
Evidence-Based Practice Institute Recruiting
Seattle, Washington, United States, 98144
Contact: Research Team    206-455-7934 ext 83    research@ebpi.org   
Sponsors and Collaborators
Evidence-Based Practice Institute, Seattle, WA
National Institute of Mental Health (NIMH)
University of Maryland
Investigators
Principal Investigator: Linda Dimeff, PhD Evidence-Based Practice Institute
Principal Investigator: Cindy Schaeffer, PhD University of Maryland

Responsible Party: Evidence-Based Practice Institute, Seattle, WA
ClinicalTrials.gov Identifier: NCT03065517     History of Changes
Other Study ID Numbers: R44MH097349 ( U.S. NIH Grant/Contract )
R44MH097349 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evidence-Based Practice Institute, Seattle, WA:
Criminal Justice
Juvenile Delinquency

Additional relevant MeSH terms:
Mental Disorders
Child Behavior Disorders
Neurodevelopmental Disorders