Digital Therapeutics for Behavior Problems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-03

Study Completion Date

2027-04-30

Brief Summary

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In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).

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Detailed Description

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In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.

Conditions

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Problem Behavior Child Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized control trial. The investigators will use stratified randomization to ensure that the groups are equivalent on key clinical features. Randomization will take place after completion of the initial baseline assessment. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app; n = 108), Group 2 (coach-assisted app; n = 108), or Group 3 (control app; n = 108).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1: Standalone App

Standalone parenting app called UseIt!

Group Type EXPERIMENTAL

UseIt! App

Intervention Type BEHAVIORAL

The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.

Group 2: App plus Coach

Standalone parenting app called UseIt! plus a coach.

Group Type EXPERIMENTAL

UseIt! App

Intervention Type BEHAVIORAL

The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.

Coach

Intervention Type BEHAVIORAL

The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system.

Group 3: Control App

Control condition: mindfulness app called SmilingMind.

Group Type ACTIVE_COMPARATOR

SmilingMind App

Intervention Type BEHAVIORAL

The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.

Interventions

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UseIt! App

The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.

Intervention Type BEHAVIORAL

Coach

The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system.

Intervention Type BEHAVIORAL

SmilingMind App

The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Males or females between the ages of 5-8 years
* Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
* Residence with at least one parent/guardian at least 80% of the time
* Parent/legal guardian consent for participation
* Parent/guardian must have a smartphone device with daily internet access

Exclusion Criteria

* A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
* Currently in treatment for childhood disruptive behavior

Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No