Skip to main content
OpenTrials
Completed

NCT Number: NCT04779333

Lifestyle Enhancement for ADHD Program 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEAP

Behavioral

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

Standard BMT

Behavioral

Weekly BMT groups sessions which follow the Barkley curriculum

Primary outcomes

  1. Effects of intervention on Physical Activity

    Time frame: Baseline to 10 weeks

    Comparing within-subject pre to post activity (MVPA) using accelerometer data

  2. Effects of intervention on Physical Activity

    Time frame: Baseline to 20 weeks

    Comparing within-subject pre to post activity (MVPA) using accelerometer data

  3. Effects of intervention on Physical Activity

    Time frame: Baseline to 1 year

    Comparing within-subject pre to post activity (MVPA) using accelerometer data

Secondary outcomes

  1. Effects of LEAP participation on child executive function

    Time frame: Baseline to 10 weeks

    Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure

  2. Effects of LEAP participation on child executive function

    Time frame: Baseline to 20 weeks

    Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure

  3. Effects of LEAP participation on child executive function

    Time frame: Baseline to 1 year

    Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure

  4. Effects of LEAP participation on child ADHD symptoms

    Time frame: Baseline to 10 weeks

    Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale

  5. Effects of LEAP participation on child ADHD symptoms

    Time frame: Baseline to 20 weeks

    Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale

  6. Effects of LEAP participation on child ADHD symptoms

    Time frame: Baseline to 1 year

    Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Lifestyle Enhancement for ADHD Program (LEAP) Study 2

Acronym: LEAP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.