Problem Behavior, Child Behavior
Conditions
Keywords
Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Childhood Behavioral Disorders, Mobile Health
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.
Interventions
BEHAVIORALUseIt! 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.
BEHAVIORALCoach
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.
BEHAVIORALSmilingMind App
The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
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).
Eligibility
Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Effective Parenting Test (KEPT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Skill Use Diary (PSUD) | 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. |
| Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment | 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. |
| Conduct Disorder Subscale of the Vanderbilt Assessment | 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. |
Countries
United States
Contacts
Primary ContactAbby Angus, BS
Outcome results
None listed