Lifestyle Enhancement for ADHD Program 2

NCT ID: NCT04779333

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-09
• Study Completion Date: 2023-04-28

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LEAP

Intervention Type: BEHAVIORAL

LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker \& facebook group.

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.

Group Type: ACTIVE_COMPARATOR

Standard BMT

Intervention Type: BEHAVIORAL

Weekly BMT groups sessions which follow the Barkley curriculum

Interventions

LEAP

LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker \& facebook group.

Intervention Type: BEHAVIORAL

Standard BMT

Weekly BMT groups sessions which follow the Barkley curriculum

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• - 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

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pooja Tandon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pooja Tandon, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Erin Gonzalez, PHD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

R33AT010041

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002356

Identifier Type: -

Identifier Source: org_study_id