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Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes (VillageWhere)

Primary Purpose

Child Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VillageWhere 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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Teen: English speaking, between ages of 13 and 17, juvenile justice involvement and/or externalizing behavioral problems, currently in treatment and will remain in treatment for duration of trial
  • Caregiver: English speaking, owns Android smart phone, currently in treatment with their teen and will remain in treatment for duration of trial

Exclusion Criteria:

  • N/A

Sites / Locations

  • Evidence-Based Practice Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of VillageWhere App Prototype

Arm Description

In this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.

Outcomes

Primary Outcome Measures

App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen
Percent of parents who set up a behavior plan for teen using app features.
App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
App Usage - Parent Set Geolocation Expectations for the Teen.
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met
The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.
App Usage - Viewed Parent Coaching Videos
The app included 5 brief video vignettes depicting an effective parenting technique.
App Usage - View Progress Graph (Points Earned Over Time)
Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.
App Satisfaction Rating - the App Was Helpful Today
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?
App Satisfaction Rating - I Have Ways to Intervene With my Teen.
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.
App Satisfaction Rating - Overall Satisfaction
Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?
App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior
Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.
App Satisfaction - I Like Getting Prompts and Reminders
Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), "I like getting prompts and reminders from the app."

Secondary Outcome Measures

Achenbach System of Empirically-Based Assessment, Aggression Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the aggression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 36; a score of 13 or higher indicates clinically significant aggression, defined as aggression that is higher than that of 93% of teens in the United States.
Achenbach System of Empirically-Based Assessment, Depression Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the depression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 26; a score of 8 or higher indicates clinically significant depression, defined as depressive symptoms higher than that of 93% of teens in the United States.
Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the rule-breaking subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 34; a score of 9 or higher indicates clinically significant rule-breaking, defined as rule-breaking that is higher than that of 93% of teens in the United States.
Loeber Parental Supervision Scale
This measure of extent to which parents supervise and monitor youth whereabouts was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 8-item scale has a scored range of 0 (minimum score) - 16 (maximum score), with high scores indicating more or better parental supervision/monitoring.
Loeber Positive Parenting Scale
This measure of extent to which parents express warmth and encouragement to youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 9-item scale has a scored range of 0 (minimum score) - 18 (maximum score), with high scores indicating more parental positivity.
Loeber Parental Consistency Scale
This measure of extent to which parents are consistent in their rules, expectations, and discipline techniques with youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage. This 5-item scale has a scored range of 0 (minimum score) - 10 (maximum score), with high scores indicating more consistent / better parental discipline follow-through.
Loeber Parental Effectiveness Scale
Degree to which parents feel that their parenting techniques are working in terms of managing teen behavior challenges. This 3-item scale has a scored range of 0 (minimum score) - 8 (maximum score), with high scores indicating better discipline effectiveness (e.g., "I feel like the punishment I give works in curbing youth behavior").
Perceived Stress Scale (PSS)
Degree to which parents are experiencing stress related to parenting. This 10-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating more stress related to parenting.
Parental Locus of Control Scale
Degree to which parents feel efficacious and confident in managing parenting challenges. This 20-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating that the parent has a higher sense of feeling efficacious in their role as a parent.
Loeber Parental Knowledge Scale
Youth report of how much parents actually know about the youth's whereabouts/activities. This 5-item scale has a scored range of 0 (minimum score) - 15 (maximum score), with high scores indicating that the parent knows more about what teens are actually doing.

Full Information

First Posted
December 16, 2014
Last Updated
January 17, 2018
Sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
National Institute of Mental Health (NIMH), Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02320903
Brief Title
Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes
Acronym
VillageWhere
Official Title
Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (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), Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the current trial is to assess the feasibility of a newly developed prototype of a cell phone app called VillageWhere. VillageWhere is designed to improve clinical outcomes of youth with externalizing behavioral problems by improving parental monitoring of youth whereabouts and activities while increasing the delivery of rewards to teens for good behavior. This Phase I Small Business Innovation Research (SBIR) proposal seeks to develop and conduct initial feasibility testing of the VillageWhere prototype. The primary features of the prototype include location monitoring via smartphones' global positioning system (GPS) functionality as well as facilitating teen self-appraisal of meeting behavioral expectations. Good behavior is rewarded with points that are tracked by the app and can be used to redeem for real-world rewards. The investigators will conduct an 45-day open trial (N=20 caregiver/teen dyads) to assess use, feasibility and acceptability for teens involved in the juvenile justice system or otherwise struggling with externalizing behavioral problems. Caregivers and teens will be assessed at baseline, before receiving the app, and at the end of the app use period (45 days). The therapist of each caregiver/teen dyad will also be assessed at the end of the app use period. Primary outcomes include: use of app features, monitoring of teen behavior and whereabouts, delivery of real-world rewards, and feasibility and acceptability. Secondary outcomes include: parenting behaviors, externalizing teen behaviors and internalizing teen behaviors.
Detailed Description
VillageWhere was pilot tested with a sample of 16 youth and their primary caregiver participating in an EST for a serious conduct problem (Mean age 14.6 years, 52% male, 56% African American, 33% were previously arrested). After completing baseline self-report measures, dyads used the app as desired for 4 weeks, then participated in a post-assessment and qualitative interviews. App usage by both parents and youth was high with little diminished use over the four weeks of the trial. All parents set and used reinforcers for functional behavior and used the "find my teen" feature; 84% set geolocation expectations for youth's whereabouts at specific times; and 88% set other expectations for the youth (e.g., finish homework), viewed notifications, and regularly used the "Find My Teen" feature. As expected, parents interacted with the app frequently: 2.4 times per day. Youth used the app on average four times per day. All youth earned and redeemed points for complying with their parent's expectations and routinely viewed their behavior plans (93.3%) and feedback notification messages (86.7%). Parents did not on average use coaching videos (20%). Although the study was not powered to detect statistical significance, a series of paired t-tests were conducted to examine pre- to post-changes on self-report measures. Changes for parents and youth all were in predicted directions, with effect sizes ranging from small to high (average d = .42, range .21-.80). Parents reported greater use of positive parenting behaviors (i.e., rewards and praise), greater discipline consistency, lower overall perceived stress, a higher feeling of influence over youth behavior, and greater parenting efficacy. Youth reported increases in parent use of positive behaviors, consistency, and knowledge of whereabouts. Parent- and youth-reported change in youth aggression and rule-breaking (as measured by the CBCL/YSR). Qualitative results were also positive. Using 7-point scales, parents and youth reported on app satisfaction three times/week. Parent ratings were high (M = 6.0) across items (e.g., "The app was helpful today," "I have ways to intervene with my teen"). Youth satisfaction scores were also high (M = 6.1; e.g., "My parent is noticing & rewarding my good behavior;" "I liked getting app prompts & reminders"). Parents reported that the app helped them trust their youth, increase their use of rewards, and made giving rewards easier; they also reported a reduction in youths' "excuse-making." Youth perceived that the app allowed them more freedom, because parents had an objective way of verifying their whereabouts. Nearly all youth (89%) liked that their parent was more consistent in paying attention to their positive behaviors and rewarding them for it (versus only being punitive). Both parents and youth described significant improvements in their relationship. In addition, 16 therapists working with the parent-youth dyads also gave qualitative feedback that was highly positive. Therapists stated that they liked the extra accountability the app afforded to teens and the reduction in parent-youth communication issues.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of VillageWhere App Prototype
Arm Type
Experimental
Arm Description
In this single-arm study design, all enrolled caregivers and teens will use the VillageWhere App Prototype that has been developed for this study. They are requested to use it as often as they would like throughout the duration of the trial. The app is designed to be used several times throughout each day.
Intervention Type
Device
Intervention Name(s)
VillageWhere App
Primary Outcome Measure Information:
Title
App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen
Description
Percent of parents who set up a behavior plan for teen using app features.
Time Frame
up to 45-days
Title
App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior
Description
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
Time Frame
up to 45-days
Title
App Usage - Parent Set Geolocation Expectations for the Teen.
Description
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
Time Frame
up to 45-days
Title
App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met
Description
The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.
Time Frame
up to 45 days
Title
App Usage - Viewed Parent Coaching Videos
Description
The app included 5 brief video vignettes depicting an effective parenting technique.
Time Frame
up to 45 days
Title
App Usage - View Progress Graph (Points Earned Over Time)
Description
Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.
Time Frame
up to 45 days
Title
App Satisfaction Rating - the App Was Helpful Today
Description
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?
Time Frame
up to 45 days
Title
App Satisfaction Rating - I Have Ways to Intervene With my Teen.
Description
Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.
Time Frame
up to 45 days
Title
App Satisfaction Rating - Overall Satisfaction
Description
Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?
Time Frame
up to 45 days
Title
App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior
Description
Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.
Time Frame
up to 45 days
Title
App Satisfaction - I Like Getting Prompts and Reminders
Description
Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), "I like getting prompts and reminders from the app."
Time Frame
up to 45 days
Secondary Outcome Measure Information:
Title
Achenbach System of Empirically-Based Assessment, Aggression Subscale
Description
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the aggression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 36; a score of 13 or higher indicates clinically significant aggression, defined as aggression that is higher than that of 93% of teens in the United States.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Achenbach System of Empirically-Based Assessment, Depression Subscale
Description
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the depression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 26; a score of 8 or higher indicates clinically significant depression, defined as depressive symptoms higher than that of 93% of teens in the United States.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale
Description
The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the rule-breaking subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 34; a score of 9 or higher indicates clinically significant rule-breaking, defined as rule-breaking that is higher than that of 93% of teens in the United States.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Loeber Parental Supervision Scale
Description
This measure of extent to which parents supervise and monitor youth whereabouts was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 8-item scale has a scored range of 0 (minimum score) - 16 (maximum score), with high scores indicating more or better parental supervision/monitoring.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Loeber Positive Parenting Scale
Description
This measure of extent to which parents express warmth and encouragement to youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 9-item scale has a scored range of 0 (minimum score) - 18 (maximum score), with high scores indicating more parental positivity.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Loeber Parental Consistency Scale
Description
This measure of extent to which parents are consistent in their rules, expectations, and discipline techniques with youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage. This 5-item scale has a scored range of 0 (minimum score) - 10 (maximum score), with high scores indicating more consistent / better parental discipline follow-through.
Time Frame
Baseline and Post assessment (end of 45-day app use period)
Title
Loeber Parental Effectiveness Scale
Description
Degree to which parents feel that their parenting techniques are working in terms of managing teen behavior challenges. This 3-item scale has a scored range of 0 (minimum score) - 8 (maximum score), with high scores indicating better discipline effectiveness (e.g., "I feel like the punishment I give works in curbing youth behavior").
Time Frame
Change over 30 days of app usage (baseline to post-assessment)
Title
Perceived Stress Scale (PSS)
Description
Degree to which parents are experiencing stress related to parenting. This 10-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating more stress related to parenting.
Time Frame
Change over 30 days of app usage (baseline to post-assessment)
Title
Parental Locus of Control Scale
Description
Degree to which parents feel efficacious and confident in managing parenting challenges. This 20-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating that the parent has a higher sense of feeling efficacious in their role as a parent.
Time Frame
Change over 30 days of app usage (baseline to post-assessment)
Title
Loeber Parental Knowledge Scale
Description
Youth report of how much parents actually know about the youth's whereabouts/activities. This 5-item scale has a scored range of 0 (minimum score) - 15 (maximum score), with high scores indicating that the parent knows more about what teens are actually doing.
Time Frame
over 30 days of app usage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Teen: English speaking, between ages of 13 and 17, juvenile justice involvement and/or externalizing behavioral problems, currently in treatment and will remain in treatment for duration of trial Caregiver: English speaking, owns Android smart phone, currently in treatment with their teen and will remain in treatment for duration of trial Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda A. Dimeff, PhD
Organizational Affiliation
Evidence-Based Practice Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cindy M 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

Learn more about this trial

Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes

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