NCT02320903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

December 16, 2014

Results QC Date

July 28, 2017

Last Update Submit

January 17, 2018

Conditions

Keywords

Criminal JusticeJuvenile Delinquency

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • 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

  • 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

  • App Usage - Viewed Parent Coaching Videos

    The app included 5 brief video vignettes depicting an effective parenting technique.

    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.

    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?

    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.

    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?

    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.

    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."

    up to 45 days

Secondary Outcomes (10)

  • Achenbach System of Empirically-Based Assessment, Aggression Subscale

    Baseline and Post assessment (end of 45-day app use period)

  • Achenbach System of Empirically-Based Assessment, Depression Subscale

    Baseline and Post assessment (end of 45-day app use period)

  • Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale

    Baseline and Post assessment (end of 45-day app use period)

  • Loeber Parental Supervision Scale

    Baseline and Post assessment (end of 45-day app use period)

  • Loeber Positive Parenting Scale

    Baseline and Post assessment (end of 45-day app use period)

  • +5 more secondary outcomes

Study Arms (1)

Use of VillageWhere App Prototype

EXPERIMENTAL

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

Interventions

Use of VillageWhere App Prototype

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evidence-Based Practice Institute

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Linda Dimeff, PhD
Organization
Evidence-Based Practice Institute

Study Officials

  • Linda A. Dimeff, PhD

    Evidence-Based Practice Institute

    PRINCIPAL INVESTIGATOR
  • Cindy M Schaeffer, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 14, 2018

Results First Posted

February 14, 2018

Record last verified: 2017-11

Locations