Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes

Child Behavior Disorders Clinical Trial

— VillageWhere  

Official title:

Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320903
• Other study ID #: 1R43MH097349-01
• Secondary ID: 1R43MH097349-01
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: January 17, 2018
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2017
• Source: Evidence-Based Practice Institute, Seattle, WA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Child Behavior Disorders
• Mental Disorders

Intervention

Device:
• VillageWhere App

Locations

Country	Name	City	State
United States	Evidence-Based Practice Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Evidence-Based Practice Institute, Seattle, WA	Medical University of South Carolina, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 45-days
Primary	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.	up to 45-days
Primary	App Usage - Parent Set Geolocation Expectations for the Teen.	Percentage of parent/caregivers who set either required or off-limits locations for their teens.	up to 45-days
Primary	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.	up to 45 days
Primary	App Usage - Viewed Parent Coaching Videos	The app included 5 brief video vignettes depicting an effective parenting technique.	up to 45 days
Primary	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.	up to 45 days
Primary	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?	up to 45 days
Primary	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.	up to 45 days
Primary	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?	up to 45 days
Primary	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.	up to 45 days
Primary	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."	up to 45 days
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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.	Baseline and Post assessment (end of 45-day app use period)
Secondary	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").	Change over 30 days of app usage (baseline to post-assessment)
Secondary	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.	Change over 30 days of app usage (baseline to post-assessment)
Secondary	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.	Change over 30 days of app usage (baseline to post-assessment)
Secondary	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.	over 30 days of app usage