Clinical trial NCT05647772: Digital Therapeutics for Behavior Problems
Official title: Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problem Behavior
Child Behavior
Keywords: Oppositional Defiant Disorder (ODD)
Conduct Disorder (CD)
Childhood Behavioral Disorders
Mobile Health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-12-12
Enrollment: 324
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge of Effective Parenting Test (KEPT)
timeFrame: Post assessment (4 months after baseline).
measure: Knowledge of Effective Parenting Test (KEPT)
timeFrame: 6-month follow-up (10 months after baseline).
Secondary outcomes:
measure: Parenting Skill Use Diary (PSUD)
timeFrame: Post assessment (4 months after baseline).
measure: Parenting Skill Use Diary (PSUD)
timeFrame: 6-month follow-up (10 months after baseline).
measure: Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
timeFrame: Post assessment (4 months after baseline).
measure: Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
timeFrame: 6-month follow-up (10 months after baseline).
measure: Conduct Disorder Subscale of the Vanderbilt Assessment
timeFrame: Post assessment (4 months after baseline).
measure: Conduct Disorder Subscale of the Vanderbilt Assessment
timeFrame: 6-month follow-up (10 months after baseline).
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Bellefield Towers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Department of Psychiatry
name: Oliver Lindhiem, PhD
role: PRINCIPAL_INVESTIGATOR
References: