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

Sponsor
Evidence-Based Practice Institute, Seattle, WA (Industry)
Overall Status
Completed
CT.gov ID
NCT03065517
Collaborator
National Institute of Mental Health (NIMH) (NIH), University of Maryland, Baltimore (Other)
226
1
2
19.4
11.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VillageWhere App
  • Device: Attention-Control Placebo App
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
226 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 :
Jul 16, 2018
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Feb 28, 2020

Arms and Interventions

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 12 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 12 week trial.

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

Outcome Measures

Primary Outcome Measures

  1. Child Behavior Checklist (CBCL) [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  2. Youth Self-Report (YSR) [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  3. Self-Report of Delinquent Behavior Scale [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  4. GAIN Substance Frequency Scale [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  5. Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS) [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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).

  6. Perceived Autonomy Support (PAS) [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  7. Perceived Stress Scale (PSS) [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome.

  8. Parent Locus of Control Scale [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

  9. Loeber Parenting Scale [Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4).]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Evidence-Based Practice Institute Seattle Washington United States 98144

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Linda Dimeff, PhD, Evidence-Based Practice Institute
  • Principal Investigator: Cindy Schaeffer, PhD, University of Maryland, Baltimore

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Evidence-Based Practice Institute, Seattle, WA
ClinicalTrials.gov Identifier:
NCT03065517
Other Study ID Numbers:
  • R44MH097349
  • R44MH097349
First Posted:
Feb 28, 2017
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail We received 645 dyad referrals. 40 were lost to follow-up, meaning 605 dyads completed the initial screen. 354 of those dyads were ineligible. Of the 251 dyads eligible for the study, 142 were lost to follow-up or dropped (mostly for no longer being interested) before consent. 113 dyads were consented, 110 had youth assent obtained, and 108 were randomized to a condition.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Period Title: Overall Study
STARTED 110 106
COMPLETED 84 90
NOT COMPLETED 26 16

Baseline Characteristics

Arm/Group Title VillageWhere App Attention-Control Placebo App Total
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms. Total of all reporting groups
Overall Participants 55 53 108
Age (Count of Participants)
<=18 years
50
90.9%
51
96.2%
101
93.5%
Between 18 and 65 years
0
0%
0
0%
0
0%
>=65 years
0
0%
0
0%
0
0%
Age (Count of Participants)
<=18 years
1
1.8%
0
0%
1
0.9%
Between 18 and 65 years
54
98.2%
52
98.1%
106
98.1%
>=65 years
0
0%
1
1.9%
1
0.9%
Sex: Female, Male (Count of Participants)
Female
25
45.5%
23
43.4%
48
44.4%
Male
29
52.7%
30
56.6%
59
54.6%
Sex: Female, Male (Count of Participants)
Female
49
89.1%
52
98.1%
101
93.5%
Male
6
10.9%
1
1.9%
7
6.5%
Race/Ethnicity, Customized (Count of Participants)
More than One Race or Other
6
10.9%
2
3.8%
8
7.4%
American Indian or Alaskan Native
2
3.6%
1
1.9%
3
2.8%
Asian
1
1.8%
1
1.9%
2
1.9%
Black
8
14.5%
9
17%
17
15.7%
White
38
69.1%
40
75.5%
78
72.2%
Race/Ethnicity, Customized (Count of Participants)
More than One Race or Other
10
18.2%
6
11.3%
16
14.8%
American Indian or Alaskan Native
2
3.6%
1
1.9%
3
2.8%
Asian
0
0%
1
1.9%
1
0.9%
Black
10
18.2%
10
18.9%
20
18.5%
White
32
58.2%
35
66%
67
62%
Region of Enrollment (participants) [Number]
United States
55
100%
53
100%
108
100%
Region of Enrollment (participants) [Number]
United States
55
100%
53
100%
108
100%
Hispanic (Youth) (Count of Participants)
Hispanic
15
27.3%
5
9.4%
20
18.5%
Not Hispanic
40
72.7%
48
90.6%
88
81.5%
Hispanic (Parent) (Count of Participants)
Hispanic
46
83.6%
3
5.7%
49
45.4%
Not Hispanic
9
16.4%
50
94.3%
59
54.6%
Arrest (Youth-Only) (Count of Participants)
Has been arrested
7
12.7%
5
9.4%
12
11.1%
Has not been arrested
9
16.4%
5
9.4%
14
13%
Education (Youth) (Count of Participants)
Completed 6th grade
7
12.7%
3
5.7%
10
9.3%
Completed 7th grade
9
16.4%
11
20.8%
20
18.5%
Completed 8th grade
13
23.6%
9
17%
22
20.4%
Completed 9th grade
14
25.5%
14
26.4%
28
25.9%
Completed 10th grade
5
9.1%
11
20.8%
16
14.8%
Completed 11th grade
5
9.1%
2
3.8%
7
6.5%
High school graduate
1
1.8%
1
1.9%
2
1.9%
Completed 5th grade
0
0%
2
3.8%
2
1.9%
Education (Parent) (Count of Participants)
Other
7
12.7%
1
1.9%
8
7.4%
Completed 9th grade
0
0%
2
3.8%
2
1.9%
Completed 10th grade
2
3.6%
1
1.9%
3
2.8%
High school graduate
18
32.7%
25
47.2%
43
39.8%
2-year college degree
10
18.2%
9
17%
19
17.6%
4-year college degree
15
27.3%
9
17%
24
22.2%
4-year degree + Masters
2
3.6%
5
9.4%
7
6.5%
PhD, MD, or other doctoral degree
1
1.8%
1
1.9%
2
1.9%
Relationship Status (Parent-only) (Count of Participants)
Other
3
5.5%
3
5.7%
6
5.6%
Single
12
21.8%
14
26.4%
26
24.1%
Single and living with my partner
5
9.1%
9
17%
14
13%
Married and living with teens parent
18
32.7%
15
28.3%
33
30.6%
Married and living with someone other than teens parent
5
9.1%
10
18.9%
15
13.9%
Separated or divorced/divorcing from the teens parent
10
18.2%
0
0%
10
9.3%
Separated or divorced/divorcing from someone other than the teens parent
2
3.6%
2
3.8%
4
3.7%
Relationship to Teen (Parent-only) (Count of Participants)
Biological Parent
49
89.1%
46
86.8%
95
88%
Adoptive Parent
4
7.3%
3
5.7%
7
6.5%
Stepparent
1
1.8%
1
1.9%
2
1.9%
Grandparent
1
1.8%
1
1.9%
2
1.9%
Family Member Other Than Parent
0
0%
1
1.9%
1
0.9%
Other
0
0%
1
1.9%
1
0.9%
Employment (Parent-only) (Count of Participants)
Employed
31
56.4%
38
71.7%
69
63.9%
Unemployed
24
43.6%
14
26.4%
38
35.2%
Income (Parent-only) (Count of Participants)
Less than $10,000
7
12.7%
6
11.3%
13
12%
$10,001 to $20,000
8
14.5%
6
11.3%
14
13%
$20,001 to $30,000
6
10.9%
13
24.5%
19
17.6%
$30,001 to $40,000
6
10.9%
4
7.5%
10
9.3%
$40,001 to $50,000
4
7.3%
5
9.4%
9
8.3%
$50,001 to $60,000
7
12.7%
7
13.2%
14
13%
$60,000 and above
17
30.9%
12
22.6%
29
26.9%

Outcome Measures

1. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
The number analyzed differs between rows because of attrition over different timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 53
Rule-Breaking Time 1
10.73
(5.86)
11.45
(5.51)
Rule-Breaking Time 2
7.88
(5.50)
7.49
(5.19)
Rule-Breaking Time 3
6.98
(5.43)
7.31
(5.90)
Rule-Breaking Time 4
7.12
(5.95)
6.69
(6.29)
Aggressive Behavior Time 1
19.31
(8.22)
20.53
(7.80)
Aggressive Behavior Time 2
14.14
(6.43)
13.53
(7.84)
Aggressive Behavior Time 3
11.93
(7.40)
12.89
(7.50)
Aggressive Behavior Time 4
10.93
(8.23)
12.70
(8.48)
2. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
The number analyzed differs between rows because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 52
Rule-Breaking Time 1
11.07
(5.66)
10.33
(4.87)
Rule-Breaking Time 2
9.41
(4.38)
8.40
(4.34)
Rule-Breaking Time 3
9.50
(5.41)
7.02
(3.38)
Rule-Breaking Time 4
9.70
(5.38)
7.07
(4.71)
Aggressive Behavior Time 1
16.22
(7.50)
15.25
(7.05)
Aggressive Behavior Time 2
13.88
(6.54)
11.86
(5.79)
Aggressive Behavior Time 3
12.08
(6.60)
9.67
(5.29)
Aggressive Behavior Time 4
11.93
(8.40)
10.51
(5.86)
3. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
Number analyzed differs between rows because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 51
General Delinquency Time 1
16.91
(64.41)
7.96
(14.0)
General Delinquency Time 2
9.03
(15.80)
4.29
(10.14)
General Delinquency Time 3
3.74
(5.87)
3.98
(10.12)
General Delinquency Time 4
2.97
(4.73)
3.32
(5.52)
Status Offenses Time 1
3.04
(11.13)
2.24
(3.97)
Status Offenses Time 2
.9
(1.66)
.67
(1.28)
Status Offenses Time 3
0.74
(1.74)
1.04
(2.25)
Status Offenses Time 4
.73
(1.91)
1.15
(2.74)
School Delinquency Time 1
6.24
(21.56)
3.41
(5.71)
School Delinquency Time 2
5.18
(10.83)
1.8
(4.72)
School Delinquency Time 3
1.72
(3.62)
1.64
(3.61)
School Delinquency Time 4
1.41
(2.80)
1.39
(2.87)
Minor Theft Time 1
0
(0)
0
(0)
Minor Theft Time 2
0
(0)
0
(0)
Minor Theft Time 3
0
(0)
0
(0)
Minor Theft Time 4
0
(0)
0
(0)
Robbery Time 1
0
(0)
0
(0)
Robbery Time 2
0
(0)
0
(0)
Robbery Time 3
0
(0)
0
(0)
Robbery Time 4
0
(0)
0
(0)
4. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
Number analyzed differs between rows because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 52
Alcohol Days Time 1
.76
(2.227)
.48
(1.488)
Alcohol Days Time 2
.15
(.573)
.00
(.00)
Alcohol Days Time 3
.30
(.791)
.23
(.782)
Alcohol Days Time 4
.25
(.776)
.12
(.640)
Drunk Days Time 1
.51
(1.999)
.17
(.734)
Drunk Days Time 2
.00
(.00)
.00
(.00)
Drunk Days Time 3
.18
(.594)
.16
(.531)
Drunk Days Time 4
.05
(.316)
.34
(1.353)
Marijuana Days Time 1
1.63
(3.808)
1.50
(4.152)
Marijuana Days Time 2
.54
(1.951)
1.13
(3.307)
Marijuana Days Time 3
1.25
(2.976)
1.47
(3.832)
Marijuana Days Time 4
.80
(2.544)
1.12
(3.716)
5. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
Number analyzed differs between rows because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 52
Interest/Enjoyment Time 1
18.54
(7.71)
22.27
(9.18)
Interest/Enjoyment Time 2
20.68
(7.00)
24.00
(6.80)
Interest/Enjoyment Time 3
21.60
(8.96)
24.21
(10.62)
Interest/Enjoyment Time 4
22.74
(6.20)
23.71
(8.31)
Perceived Competence Time 1
24.20
(9.64)
23.90
(8.78)
Perceived Competence Time 2
25.32
(6.20)
25.69
(7.43)
Perceived Competence Time 3
23.88
(7.21)
27.38
(8.66)
Perceived Competence Time 4
27.66
(6.95)
26.76
(8.71)
Value/Usefulness Time 1
27.91
(12.06)
32.40
(11.92)
Value/Usefulness Time 2
28.80
(8.74)
31.96
(9.90)
Value/Usefulness Time 3
27.23
(10.30)
31.88
(11.27)
Value/Usefulness Time 4
30.05
(9.55)
31.95
(10.05)
Effort/Importance Time 1
19.15
(4.93)
20.19
(4.91)
Effort/Importance Time 2
18.95
(3.71)
21.56
(5.01)
Effort/Importance Time 3
19.48
(4.60)
21.81
(4.61)
Effort/Importance Time 4
19.68
(3.76)
20.39
(3.91)
6. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
Number analyzed in rows differs from overall number analyzed because of separation of youth and parent subscales and attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 108 105
Parent Autonomy Time 1
15.20
(3.07)
15.23
(3.17)
Parent Autonomy Time 2
15.33
(2.67)
15.71
(2.87)
Parent Autonomy Time 3
15.46
(2.99)
15.98
(2.90)
Parent Autonomy Time 4
16.20
(2.84)
15.98
(3.30)
Parent Chaos Time 1
8.20
(2.59)
7.91
(2.43)
Parent Chaos Time 2
7.83
(2.61)
8.24
(3.61)
Parent Chaos Time 3
8.10
(2.54)
7.76
(3.08)
Parent Chaos Time 4
7.22
(2.04)
7.91
(3.83)
Parent Coercion Time 1
13.22
(3.63)
12.81
(3.83)
Parent Coercion Time 2
12.00
(3.38)
11.78
(3.62)
Parent Coercion Time 3
12.00
(3.22)
11.62
(3.77)
Parent Coercion Time 4
11.46
(3.44)
10.89
(3.94)
Parent Structure Time 1
16.35
(2.70)
16.17
(3.37)
Parent Structure Time 2
16.17
(2.68)
16.24
(2.91)
Parent Structure Time 3
16.85
(2.47)
17.11
(2.96)
Parent Structure Time 4
17.46
(2.65)
16.80
(3.40)
Youth Autonomy Time 1
9.48
(3.25)
10.48
(3.37)
Youth Autonomy Time 2
9.46
(2.65)
9.98
(3.49)
Youth Autonomy Time 3
9.60
(3.12)
10.47
(2.82)
Youth Autonomy Time 4
9.69
(3.05)
10.78
(3.31)
Youth Chaos Time 1
8.11
(3.15)
8.52
(2.94)
Youth Chaos Time 2
8.10
(2.96)
8.42
(2.84)
Youth Chaos Time 3
8.23
(3.03)
7.67
(2.96)
Youth Chaos Time 4
8.30
(3.20)
8.24
(3.35)
Youth Coercion Time 1
9.93
(2.52)
10.10
(2.54)
Youth Coercion Time 2
9.56
(2.61)
9.58
(2.48)
Youth Coercion Time 3
9.65
(2.32)
9.30
(2.44)
Youth Coercion Time 4
9.46
(2.76)
9.39
(2.65)
Youth Structure Time 1
10.46
(3.33)
11.35
(3.17)
Youth Structure Time 2
10.02
(3.08)
10.44
(3.33)
Youth Structure Time 3
10.05
(3.10)
10.67
(3.15)
Youth Structure Time 4
9.83
(3.20)
10.37
(3.37)
7. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
The number analyzed differs in the rows because of attrition over time points.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 54 53
Time 1
22.06
(7.29)
20.74
(5.34)
Time 2
18.83
(5.56)
19.62
(5.99)
Time 3
18.61
(7.70)
18.56
(6.51)
Time 4
16.68
(8.06)
17.45
(5.70)
8. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
Number analyzed in certain rows differs from overall number analyzed because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 55 53
Helpless Time 1
24.80
(5.40)
24.77
(5.37)
Helpless Time 2
22.67
(4.30)
22.71
(4.98)
Helpless Time 3
22.73
(4.31)
22.40
(6.15)
Helpless Time 4
21.29
(5.22)
21.14
(5.33)
Out of Control Time 1
32.84
(7.85)
34.23
(7.13)
Out of Control Time 2
31.31
(6.56)
30.53
(7.95)
Out of Control Time 3
29.78
(6.60)
29.33
(9.26)
Out of Control Time 4
27.49
(8.00)
27.93
(8.97)
9. Primary Outcome
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).

Outcome Measure Data

Analysis Population Description
The number analyzed differs between rows because of attrition over timepoints.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
Measure Participants 54 53
Supervision Time 1
26.33
(3.08)
25.53
(3.69)
Supervision Time 2
21.98
(1.70)
22.04
(2.14)
Supervision Time 3
22.00
(1.91)
22.53
(2.14)
Supervision Time 4
22.44
(1.87)
22.23
(2.26)
Inconsistent Discipline Time 1
8.40
(2.02)
8.43
(2.27)
Inconsistent Discipline Time 2
7.50
(1.85)
7.80
(2.16)
Inconsistent Discipline Time 3
7.71
(2.00)
7.98
(2.37)
Inconsistent Discipline Time 4
7.02
(1.80)
7.82
(2.34)
Reward Use Time 1
21.09
(2.47)
21.19
(3.43)
Reward Use Time 2
21.50
(2.81)
21.87
(3.00)
Reward Use Time 3
21.90
(2.53)
21.87
(3.14)
Reward Use Time 4
22.22
(2.58)
21.68
(2.77)
Discipline Effectiveness Time 1
5.94
(1.86)
5.77
(1.90)
Discipline Effectiveness Time 2
6.60
(1.71)
6.69
(2.16)
Discipline Effectiveness Time 3
6.73
(1.63)
6.93
(2.19)
Discipline Effectiveness Time 4
7.22
(1.84)
7.23
(2.21)

Adverse Events

Time Frame 12 weeks
Adverse Event Reporting Description Participants were asked to report potential and actual adverse events, whether or not the individual considered the event resulting from the research, via online survey, to IRB, or study PI.
Arm/Group Title VillageWhere App Attention-Control Placebo App
Arm/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 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. 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. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms.
All Cause Mortality
VillageWhere App Attention-Control Placebo App
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/106 (0%)
Serious Adverse Events
VillageWhere App Attention-Control Placebo App
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/106 (0%)
Other (Not Including Serious) Adverse Events
VillageWhere App Attention-Control Placebo App
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/106 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Angela Kelley Brimer
Organization Evidence-Based Practice Institute, Inc.
Phone 253-279-8659
Email research@jasprhealth.com
Responsible Party:
Evidence-Based Practice Institute, Seattle, WA
ClinicalTrials.gov Identifier:
NCT03065517
Other Study ID Numbers:
  • R44MH097349
  • R44MH097349
First Posted:
Feb 28, 2017
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022