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OpenTrials
Active, Not Recruiting

NCT Number: NCT05647772

Digital Therapeutics for Behavior Problems

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Problem Behavior Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Child Behavior Conduct Disorder Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UseIt! App

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

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.

SmilingMind App

Behavioral

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

Primary outcomes

  1. Knowledge of Effective Parenting Test (KEPT)

    Time frame: Post assessment (4 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.

  2. Knowledge of Effective Parenting Test (KEPT)

    Time frame: 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 outcomes

  1. Parenting Skill Use Diary (PSUD)

    Time frame: Post assessment (4 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.

  2. Parenting Skill Use Diary (PSUD)

    Time frame: 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.

  3. Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment

    Time frame: Post assessment (4 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.

  4. Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment

    Time frame: 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.

  5. Conduct Disorder Subscale of the Vanderbilt Assessment

    Time frame: Post assessment (4 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.

  6. Conduct Disorder Subscale of the Vanderbilt Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 12, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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