Digital Therapeutics for Behavior Problems

Reach and Scalability of Digital Therapeutics for Childhood 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).

Study Overview

• Status: Recruiting
• Conditions: Problem Behavior; Child Behavior
• Intervention / Treatment: Behavioral: UseIt! App; Behavioral: Coach; Behavioral: SmilingMind 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 Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristie Mak, BSc; Phone Number: 412-246-5901; Email: makk2@upmc.edu
• Study Contact Backup: Name: Devin Gaffney, BSc; Email: gaffneyd@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Bellefield Towers
      • Contact: Kristie Mak, BSc; Phone Number: 412-246-5901; Email: makk2@upmc.edu
      • Contact: Devin Gaffney, BSc; Email: gaffneyd@upmc.edu
      • Principal Investigator: Oliver Lindhiem, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Oliver Lindhiem, PhD, University of Pittsburgh, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mobile Health; Oppositional Defiant Disorder (ODD); Conduct Disorder (CD); Childhood Behavioral Disorders
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: STUDY22030138; R01HD106930 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Following publication of primary findings at the conclusion of the study.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No