NCT04779333

Lifestyle Enhancement for ADHD Program 2

Lifestyle Enhancement for ADHD Program (LEAP) Study 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
BEHAVIORAL	LEAP	LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker \& facebook group.
BEHAVIORAL	Standard BMT	Weekly BMT groups sessions which follow the Barkley curriculum

Timeline

• Start date: 2020-09-09
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2021-03-03
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States