Lifestyle Enhancement for ADHD Program

NCT ID: NCT03690674

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2020-01-21

Brief Summary

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.

Detailed 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.

Conditions

ADHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestyle Enhancement for ADHD Program

There is no comparison/control arm.

Group Type: EXPERIMENTAL

Lifestyle Enhancement for ADHD Program

Intervention Type: BEHAVIORAL

The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.

Interventions

Lifestyle Enhancement for ADHD Program

The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.

Intervention Type: BEHAVIORAL

Other Intervention Names

LEAP

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pooja Tandon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pooja Tandon, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Erin Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AT010041-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001046

Identifier Type: -

Identifier Source: org_study_id