Lifestyle Enhancement for ADHD Program (LEAP) Study 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Effects of intervention on Physical Activity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to increase physical activity (PA) in children with ADHD using a novel, family-based intervention that promotes PA within the context of evidence-based behavioral management training (BMT) for caregivers, enhanced with mobile health (mHealth) behavior change strategies.
Primary Objective: To evaluate the primary effects of a 9-week, family-based intervention (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD
Secondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and executive functioning
Detailed Description
This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80 families will be randomized to receive either LEAP or a standard BMT program based on Russell Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI) and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT. If successful, the R33 phase will inform the development of a larger and longer, confirmatory trial.
Investigators
Pooja Tandon
Principal Investigator
Seattle Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effects of intervention on Physical Activity
Time Frame: Baseline to 1 year
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Secondary Outcomes
- Effects of LEAP participation on child ADHD symptoms(Baseline to 1 year)
- Effects of LEAP participation on child executive function(Baseline to 1 year)