An interventional study of VillageWhere App in Child Behavior Disorders, sponsored by Evidence-Based Practice Institute, Seattle, WA. Completed at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Evidence-Based Practice Institute, Seattle, WA · Not applicable, Interventional, and Treatment
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.
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.
35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.
This study's enrollment of 88 is below the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.
Browse Child Behavior Disorders studies →Evidence-Based Practice Institute, Seattle, WA is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Device: VillageWhere App
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.
Time frame: up to 45-days
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.
Time frame: up to 45-days
App Usage - Parent Set Geolocation Expectations for the Teen.
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
Time frame: up to 45-days
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.
Time frame: up to 45 days
App Usage - Viewed Parent Coaching Videos
The app included 5 brief video vignettes depicting an effective parenting technique.
Time frame: up to 45 days
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.
Time frame: up to 45 days
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?
Time frame: up to 45 days
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.
Time frame: up to 45 days
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?
Time frame: up to 45 days
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.
Time frame: up to 45 days
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."
Time frame: up to 45 days
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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.
Time frame: Baseline and Post assessment (end of 45-day app use period)
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").
Time frame: Change over 30 days of app usage (baseline to post-assessment)
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.
Time frame: Change over 30 days of app usage (baseline to post-assessment)
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.
Time frame: Change over 30 days of app usage (baseline to post-assessment)
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.
Time frame: over 30 days of app usage
We completed a four-week within-subjects pre-post trial to determine the usability, acceptability, and feasibility. MST therapists in Seattle, New York City, Hartford, and Washington, DC referred families to the study. Parents contacted the study team to indicate their interest. Therapists of referred families also were enrolled in the study.
| Milestone | Therapists | Parents/Caregivers | Youth/Teens |
|---|---|---|---|
| Started | 24 | 32 | 32 |
| Completed | 16 | 16 | 16 |
| Not completed | 8 | 16 | 16 |
| Withdrew: Withdrawal by subject | 0 | 9 | 9 |
| Withdrew: Exited therapy; no longer eligible | 8 | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 5 | 5 |
Percent of parents who set up a behavior plan for teen using app features.
| Participants | Parents/Caregivers |
|---|---|
| App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen | 16 |
How many parents/caregivers set up a reward system and redeemed at least some points for the teen.
| Participants | Parents/Caregivers |
|---|---|
| App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior | 16 |
Percentage of parent/caregivers who set either required or off-limits locations for their teens.
| Participants | Parents/Caregivers |
|---|---|
| App Usage - Parent Set Geolocation Expectations for the Teen. | 14 |
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.
| Participants | Parents/Caregivers | Youth/Teens |
|---|---|---|
| App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met | 14 | 14 |
The app included 5 brief video vignettes depicting an effective parenting technique.
| Participants | Parents/Caregivers Only |
|---|---|
| App Usage - Viewed Parent Coaching Videos | 3 |
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.
| Participants | Parents/Caregivers | Youth/Teens |
|---|---|---|
| App Usage - View Progress Graph (Points Earned Over Time) | 10 | 8 |
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?
| units on a scale | Parents/Caregivers |
|---|---|
| App Satisfaction Rating - the App Was Helpful Today | 5.95 ± .999 |
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.
| units on a scale | Parents/Caregivers Only |
|---|---|
| App Satisfaction Rating - I Have Ways to Intervene With my Teen. | 6.00 ± 1.09 |
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?
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| App Satisfaction Rating - Overall Satisfaction | 5.91 ± 1.21 | 6.14 ± 0.72 |
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.
| units on a scale | Youth/Teens Only |
|---|---|
| App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior | 6.19 ± 1.15 |
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."
| units on a scale | Youth/Teens Only |
|---|---|
| App Satisfaction - I Like Getting Prompts and Reminders | 5.62 ± 1.27 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Mean at Time 1 (baseline) | 13.75 ± 8.80 | 11.29 ± 4.82 |
| Mean at Time 2 (post-usage) | 12.31 ± 8.80 | 10.14 ± 5.43 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Pre-test mean | 6.93 ± 5.36 | 6.29 ± 4.81 |
| Post-test mean | 5.80 ± 5.17 | 4.71 ± 3.91 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Mean at Time 1 (baseline) | 9.71 ± 6.34 | 10.07 ± 4.20 |
| Mean at Time 2 (post-usage) | 9.07 ± 6.49 | 9.21 ± 4.61 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Mean at Time 1 (baseline) | 13.00 ± 2.25 | 10.86 ± 3.32 |
| Mean at Time 2 (post-usage) | 13.38 ± 2.45 | 11.50 ± 2.44 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Mean at Time 1 (baseline) | 8.87 ± 4.97 | 8.57 ± 2.24 |
| Mean at Time 2 (post-usage) | 11.39 ± 2.95 | 8.93 ± 2.79 |
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.
| units on a scale | Parents/Caregivers | Youth/Teens |
|---|---|---|
| Mean at Time 1 (baseline) | 1.87 ± 1.64 | 5.21 ± 2.01 |
| Mean at Time 2 (post-usage) | 2.27 ± 2.02 | 5.57 ± 2.87 |
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").
| units on a scale | Parents/Caregivers Only |
|---|---|
| Mean at Time 1 (baseline) | 4.20 ± 1.90 |
| Mean at Time 2 (post-usage) | 4.40 ± 1.88 |
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.
| units on a scale | Parents/Caregivers Only |
|---|---|
| Mean at Time 1 (baseline) | 18.09 ± 8.14 |
| Mean at Time 2 (post-usage) | 12.73 ± 4.45 |
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.
| units on a scale | Parents/Caregivers Only |
|---|---|
| Mean at Time 1 (baseline) | 15.25 ± 6.22 |
| Mean at Time 2 (post-usage) | 18.63 ± 8.72 |
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.
| units on a scale | Youth/Teens Only |
|---|---|
| Mean at Time 1 (baseline) | 8.07 ± 2.73 |
| Mean at Time 2 (post-usage) | 9.00 ± 3.09 |
Collected over Adverse events were informally monitored throughout the 4-week period during which time parents and teens were using the app. Also, most families had their baseline assessment sessions 1-2 weeks prior to the start of app use, and their post-assessment 1-2 weeks after finishing their use of the app. Thus, adverse events were informally monitored for the entire study period, for most families, approximately 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Use of VillageWhere App Prototype | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(Years) | Therapists | Parents/Caregivers | Youth/Teens | Total |
|---|---|---|---|---|
| Age | — | 41.7 ± 0 | 14.6 ± 1.6 | 24.15 ± 0 |
| Sex: Female, Male(Participants) | Therapists | Parents/Caregivers | Youth/Teens | Total |
|---|---|---|---|---|
| Female | 22 | 15 | 9 | 46 |
| Male | 2 | 1 | 7 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Therapists | Parents/Caregivers | Youth/Teens | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 3 | 8 |
| Not Hispanic or Latino | 20 | 12 | 11 | 43 |
| Unknown or Not Reported | 2 | 17 | 18 | 37 |
| Race (NIH/OMB)(Participants) | Therapists | Parents/Caregivers | Youth/Teens | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 5 | 5 | 11 |
| White | 5 | 9 | 8 | 22 |
| More than one race | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 17 | 17 | 18 | 52 |
| Region of Enrollment(Participants) | Therapists | Parents/Caregivers | Youth/Teens | Total |
|---|---|---|---|---|
| United States | 24 | 32 | 32 | 88 |
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Evidence-Based Practice Institute, Seattle, WA