Digital Therapeutics for Behavior Problems

Study Overview
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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).

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.

Official Title
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Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Conditions
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Problem Behavior, Child Behavior

Intervention / Treatment
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* Behavioral: UseIt! App
* Behavioral: Coach
* Behavioral: SmilingMind App


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Standalone App<br>Standalone parenting app called UseIt! | Behavioral: UseIt! App<br>* 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.<br>|
| Experimental: Group 2: App plus Coach<br>Standalone parenting app called UseIt! plus a coach. | Behavioral: UseIt! App<br>* 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.<br>Behavioral: Coach<br>* 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.<br>|
| Active Comparator: Group 3: Control App<br>Control condition: mindfulness app called SmilingMind. | Behavioral: SmilingMind App<br>* The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of Effective Parenting Test (KEPT) | Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes. | Post assessment (4 months after baseline). | 
| Knowledge of Effective Parenting Test (KEPT) | Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes. | 6-month follow-up (10 months after baseline). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting Skill Use Diary (PSUD) | Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes. | Post assessment (4 months after baseline). | 
| Parenting Skill Use Diary (PSUD) | Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes. | 6-month follow-up (10 months after baseline). | 
| Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment | Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes. | Post assessment (4 months after baseline). | 
| Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment | Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes. | 6-month follow-up (10 months after baseline). | 
| Conduct Disorder Subscale of the Vanderbilt Assessment | Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes. | Post assessment (4 months after baseline). | 
| Conduct Disorder Subscale of the Vanderbilt Assessment | Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes. | 6-month follow-up (10 months after baseline). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Childhood Behavioral Disorders, Mobile Health