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).

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.

Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Childhood Behavioral Disorders, Mobile Health

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).

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.

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.

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

Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.

Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.

Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes.

Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes.

Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes.

Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes.

Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes.

Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes.

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

All data collected for this project will be made available to other researchers for future data mining, following publication of primary findings at the conclusion of the study. The investigators will share data with other investigators within and outside the University of Pittsburgh upon submission of a standardized written request. All data sharing will follow the guidelines and rules of the NIH and our IRB. Data (both raw data and summary scores) will be shared electronically (secure digital file) as de-identified data.

To gain access, anyone not part of the original research protocol will submit a Data Analysis Request Form which requires elucidation of hypotheses to be tested and specific data requested. This form requires information about the investigator, including institutional affiliation, resume, proposed research, and conflict of interest statement. The investigator must document completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution. Investigators outside the University of Pittsburgh must also complete a Data Use and Confidentiality Agreement before release of data to them.