- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320903
Using Mobile Technology to Enhance Multisystemic Therapy (MST) Outcomes (VillageWhere)
Phase I - Using Mobile Technology to Enhance MST Outcomes (VillageWhere)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Washington
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Seattle, Washington, United States, 98144
- Evidence-Based Practice Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Use of VillageWhere App Prototype
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen
Time Frame: up to 45-days
|
Percent of parents who set up a behavior plan for teen using app features.
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up to 45-days
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App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior
Time Frame: up to 45-days
|
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
|
up to 45-days
|
App Usage - Parent Set Geolocation Expectations for the Teen.
Time Frame: up to 45-days
|
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
|
up to 45-days
|
App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met
Time Frame: up to 45 days
|
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.
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up to 45 days
|
App Usage - Viewed Parent Coaching Videos
Time Frame: up to 45 days
|
The app included 5 brief video vignettes depicting an effective parenting technique.
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up to 45 days
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App Usage - View Progress Graph (Points Earned Over Time)
Time Frame: up to 45 days
|
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
|
App Satisfaction Rating - the App Was Helpful Today
Time Frame: up to 45 days
|
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?
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up to 45 days
|
App Satisfaction Rating - I Have Ways to Intervene With my Teen.
Time Frame: up to 45 days
|
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
|
App Satisfaction Rating - Overall Satisfaction
Time Frame: up to 45 days
|
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?
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up to 45 days
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App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior
Time Frame: up to 45 days
|
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.
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up to 45 days
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App Satisfaction - I Like Getting Prompts and Reminders
Time Frame: up to 45 days
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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."
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up to 45 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achenbach System of Empirically-Based Assessment, Aggression Subscale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
|
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.
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Baseline and Post assessment (end of 45-day app use period)
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Achenbach System of Empirically-Based Assessment, Depression Subscale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
|
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.
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Baseline and Post assessment (end of 45-day app use period)
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Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
|
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.
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Baseline and Post assessment (end of 45-day app use period)
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Loeber Parental Supervision Scale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
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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.
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Baseline and Post assessment (end of 45-day app use period)
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Loeber Positive Parenting Scale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
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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.
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Baseline and Post assessment (end of 45-day app use period)
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Loeber Parental Consistency Scale
Time Frame: Baseline and Post assessment (end of 45-day app use period)
|
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.
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Baseline and Post assessment (end of 45-day app use period)
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Loeber Parental Effectiveness Scale
Time Frame: Change over 30 days of app usage (baseline to post-assessment)
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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").
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Change over 30 days of app usage (baseline to post-assessment)
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Perceived Stress Scale (PSS)
Time Frame: Change over 30 days of app usage (baseline to post-assessment)
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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.
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Change over 30 days of app usage (baseline to post-assessment)
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Parental Locus of Control Scale
Time Frame: Change over 30 days of app usage (baseline to post-assessment)
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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.
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Change over 30 days of app usage (baseline to post-assessment)
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Loeber Parental Knowledge Scale
Time Frame: over 30 days of app usage
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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.
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over 30 days of app usage
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Collaborators and Investigators
Investigators
- Principal Investigator: Linda A. Dimeff, PhD, Evidence-Based Practice Institute
- Principal Investigator: Cindy M Schaeffer, PhD, University of Maryland, Baltimore
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R43MH097349-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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