Lifestyle Enhancement for ADHD Program 2

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: LEAP; Behavioral: Standard BMT

• Registration Number: NCT04779333
• Lead Sponsor: Seattle Children's Hospital

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.

Study Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEAP Group	LEAP	In addition to the components of the BMT group, the LEAP program includes an emphasis on supporting optimal physical activity, limiting screen time, and encouraging adequate sleep. The child and caregiver are also given a wrist-worn activity tracker and caregivers participate in a motivational Facebook group.
BMT Group	Standard BMT	The BMT Group will take part in a family-based intervention within the context of evidence-based behavioral management training (BMT) for caregivers. Standard BMT represents the current standard of care for childhood ADHD.

Primary Outcome Measures

Name	Time	Method
Effects of intervention on Physical Activity	Baseline to 1 year	Comparing within-subject pre to post activity (MVPA) using accelerometer data

Secondary Outcome Measures

Name	Time	Method
Effects of LEAP participation on child ADHD symptoms	Baseline to 1 year	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Effects of LEAP participation on child executive function	Baseline to 1 year	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure

Trial Locations

Locations (1)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States