Lifestyle Enhancement for ADHD Program 2 (LEAP)

Lifestyle Enhancement for ADHD Program (LEAP) Study 2

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: LEAP; Behavioral: Standard BMT

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (child):

• Age 6-10 years
• ADHD diagnosis
• CGI-S rating ranging from 4 to 7.
• Child not wearing a wrist-worn activity tracker more than 50% of days in the past month

Inclusion Criteria (caregiver):

• One adult custodial caregiver (resides with the child at least 50% of the time) willing to participate in the study and complete baseline/follow-up measures
• Caregiver able to complete forms in English
• Caregiver owns a smart phone or similar Garmin compatible mobile device (e.g. iPod Touch) or willing to borrow iPod from study coordinators during the study period
• Agree to install and share data from the Garmin smart phone app with investigators

Inclusion Criteria (supplementary caregiver):

• An additional caregiver designated by the participating caregiver who provides care for the participating child on at least one occasion every other week
• Able to participate in one or more group sessions
• Able to consent in English

Exclusion Criteria (children):

• - Younger than 6 years old or older than 10 years old
• Do not meet criteria currently for ADHD diagnosis
• Meet diagnostic criteria for psychiatric co-morbidities of Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability (by history)
• Per caregiver report, engage in >60 min/day of MVPA consistently for at least 5 days per week
• Any physical or medical restrictions on PA
• Child currently/previously used a wearable physical activity sensing device at least 50% of days in the past month

Exclusion Criteria (caregiver):

- Caregiver participated in an evidence-based parent behavior management training program (i.e., Incredible Years, Triple P, PCIT, Barkley's Defiant Child) in the past 24 months.

Exclusion Criteria (supplementary caregiver): none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEAP Group; 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.	Behavioral: LEAP; LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.
Active Comparator: BMT Group; 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.	Behavioral: Standard BMT; Weekly BMT groups sessions which follow the Barkley curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 10 weeks
Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 20 weeks
Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 10 weeks
Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 20 weeks
Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 1 year
Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 10 weeks
Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 20 weeks
Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 1 year

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Pooja Tandon, MD, Seattle Children's; Principal Investigator: Erin Gonzalez, PHD, Seattle Children's

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: STUDY00002356; R33AT010041 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No