Digital Therapeutics for Behavior Problems

Child Behavior Clinical Trial

Official title:

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647772
• Other study ID #: STUDY22030138
• Secondary ID: R01HD106930
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2022
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Kristie Mak, BSc
• Phone: 412-246-5901
• Email: makk2[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: April 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Bellefield Towers	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).