Lifestyle Enhancement for ADHD Program (LEAP)

Seattle Children's Healthcare System

Status: Completed

Conditions: ADHD

Treatments: Behavioral: Lifestyle Enhancement for ADHD Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03690674

STUDY00001046

R21AT010041-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program.

Full description

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 parents, enhanced with mobile health (mHealth) behavior change strategies. Our first aim is to test the feasibility and acceptability, of an 8-week, family-based, multi-level intervention (BMT-Health) to promote PA in young children with ADHD. Our second aim is to derive an estimate of the effect size of the intervention on PA.

Enrollment: 35 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 5-10 years
• ADHD diagnosis
• CGI-S rating >4 and <7
• Per caregiver report, engage in <60 min/day of MVPA for at least 5 days per week
• One adult caregiver 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

Exclusion criteria

• younger than 5 years old or older than 10 years old
• do not meet criteria for ADHD diagnosis
• Meet diagnostic criteria for psychiatric co-morbidities including Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability that could interfere with intervention uptake
• Per caregiver report, engage in >60 min/day of MVPA for at least 5 days per week

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Lifestyle Enhancement for ADHD Program

Experimental group

Description:

There is no comparison/control arm.

Treatment:

Behavioral: Lifestyle Enhancement for ADHD Program