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Lifestyle Enhancement for ADHD Program 2 (LEAP)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LEAP
Standard BMT
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seattle Children's Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LEAP Group

BMT Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effects of intervention on Physical Activity
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Effects of intervention on Physical Activity
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Effects of intervention on Physical Activity
Comparing within-subject pre to post activity (MVPA) using accelerometer data

Secondary Outcome Measures

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
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
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
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
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
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

Full Information

First Posted
February 24, 2021
Last Updated
May 2, 2023
Sponsor
Seattle Children's Hospital
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04779333
Brief Title
Lifestyle Enhancement for ADHD Program 2
Acronym
LEAP
Official Title
Lifestyle Enhancement for ADHD Program (LEAP) Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEAP Group
Arm Type
Experimental
Arm Description
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.
Arm Title
BMT Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LEAP
Intervention Description
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
Intervention Name(s)
Standard BMT
Intervention Description
Weekly BMT groups sessions which follow the Barkley curriculum
Primary Outcome Measure Information:
Title
Effects of intervention on Physical Activity
Description
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time Frame
Baseline to 10 weeks
Title
Effects of intervention on Physical Activity
Description
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time Frame
Baseline to 20 weeks
Title
Effects of intervention on Physical Activity
Description
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time Frame
Baseline to 1 year
Secondary Outcome Measure Information:
Title
Effects of LEAP participation on child executive function
Description
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time Frame
Baseline to 10 weeks
Title
Effects of LEAP participation on child executive function
Description
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time Frame
Baseline to 20 weeks
Title
Effects of LEAP participation on child executive function
Description
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time Frame
Baseline to 1 year
Title
Effects of LEAP participation on child ADHD symptoms
Description
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Time Frame
Baseline to 10 weeks
Title
Effects of LEAP participation on child ADHD symptoms
Description
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Time Frame
Baseline to 20 weeks
Title
Effects of LEAP participation on child ADHD symptoms
Description
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Time Frame
Baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Tandon, MD
Organizational Affiliation
Seattle Children's
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erin Gonzalez, PHD
Organizational Affiliation
Seattle Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98145
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lifestyle Enhancement for ADHD Program 2

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