Digital Therapeutics for Behavior Problems

Not Applicable

Recruiting

• Conditions: Problem Behavior; Child Behavior
• Interventions: Behavioral: SmilingMind App; Behavioral: UseIt! App; Behavioral: Coach

• Registration Number: NCT05647772
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-30
• Study Start: 2022-12-03
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2026-10
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Control App	SmilingMind App	Control condition: mindfulness app called SmilingMind.
Group 2: App plus Coach	UseIt! App	Standalone parenting app called UseIt! plus a coach.
Group 1: Standalone App	UseIt! App	Standalone parenting app called UseIt!
Group 2: App plus Coach	Coach	Standalone parenting app called UseIt! plus a coach.

Primary Outcome Measures

Name	Time	Method
Knowledge of Effective Parenting Test (KEPT)	6-month follow-up (10 months after baseline).	Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bellefield Towers; 🇺🇸 Pittsburgh, Pennsylvania, United States