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

Primary Purpose

Child Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VillageWhere App
Attention-Control Placebo App
Sponsored by
Evidence-Based Practice Institute, Seattle, WA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Disorders focused on measuring Criminal Justice, Juvenile Delinquency

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evidence-Based Practice Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VillageWhere App

Attention-Control Placebo App

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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.
Perceived Stress Scale (PSS)
Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2017
Last Updated
May 6, 2022
Sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03065517
Brief Title
VillageWhere: Innovative Mobile Technology for Youth With Conduct Disorder and Their Parents
Acronym
VillageWhere
Official Title
Using Mobile Technology to Enhance MST Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders
Keywords
Criminal Justice, Juvenile Delinquency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VillageWhere App
Arm Type
Experimental
Arm 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.
Arm Title
Attention-Control Placebo App
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
VillageWhere App
Intervention Description
VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.
Intervention Type
Device
Intervention Name(s)
Attention-Control Placebo App
Intervention Description
Mobile phone app for use on both Android and iOS platforms.
Primary Outcome Measure Information:
Title
Child Behavior Checklist (CBCL)
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Youth Self-Report (YSR)
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Self-Report of Delinquent Behavior Scale
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
GAIN Substance Frequency Scale
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS)
Description
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).
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Perceived Autonomy Support (PAS)
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Perceived Stress Scale (PSS)
Description
Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Parent Locus of Control Scale
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).
Title
Loeber Parenting Scale
Description
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.
Time Frame
Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Dimeff, PhD
Organizational Affiliation
Evidence-Based Practice Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cindy Schaeffer, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evidence-Based Practice Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35640058
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. 2022 May 31:1-15. doi: 10.1080/15374416.2022.2070851. Online ahead of print.
Results Reference
derived

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

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