Lifestyle Enhancement for ADHD Program (LEAP)

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Lifestyle Enhancement for ADHD 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98145
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifestyle Enhancement for ADHD Program; There is no comparison/control arm.

Behavioral: 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.; Other Names: LEAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity (MVPA)	Measured by accelerometer worn by participating children	Baseline (measured prior to week 1 of Treatment Group) and week 9
Garmin Wear Time	The length of time (in days) each participant wore the Garmin device as a measure of feasibility	Weeks 1 - 9
Number of Facebook Posts	The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility	Weeks 1 - 9
Number of Caregivers With Attendance at the Focus Group	Attendance will be taken at the focus group as a measure of study acceptability	Week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop Signal Reaction Time (SSRT) Task Score	Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.	Baseline to week 9
Digit Span (DS) Task - Total Score	Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.	Baseline to week 9
Finger Windows (FW) Task	Measure of executive function completed by the child	Change between baseline and week 9
Behavior Rating Inventory of Executive Function (BRIEF)	Measure of executive function completed by the parent. Parent rates whether the child displays each behavior never, sometimes, or often. Global Executive Composite Score: Minimum 35; Maximum 90. Higher score indicates better outcome.	Change between baseline and week 9
Impairment Rating Scale (IRS)	Measure of functional impairment completed by the parent. The rating scale measures from 0 to 7, where 0 equals no problem and 7 equals extreme problem. Outcome provided as mean of total raw score. Minimum: 0; Maximum: 100. Higher number indicates higher impairment.	Change between baseline and week 9
Alabama Parenting Questionnaire (APQ)	Measure of parenting completed by the parent. The responses are on a 1-5 scale, 1 equals never and 5 equals always. Outcome provided as total raw score. Minimum: 9; Maximum: 45.Higher number indicates better outcome.	Change between baseline and week 9
Health Behaviors Survey	Measure of physical activity, sleep, media use, medication use and complementary/alternative medicine use. Measure reported is the number of Caregivers responding 'yes' to item.	Baseline and week 9
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)	The Child's Sleep Habits Questionnaire (pre-school and school-aged children) is a measure of sleep problems completed by the parent. The parent rates each behavior based on their frequency: 'Usually' if something occurs 5 or more times in a week, 'Sometimes' if it occurs 2-4 times in a week, or 'rarely' if something occurs never or 1 times during a week. Parents can also indicate whether or not a sleep habit is a problem by choosing Yes, No, or Not applicable. Total score provided is the sum of all 33 items. Item units are on a scale of 1 -3 points. The Total score range is 33 - 99. The higher the number, the more sleep problems are indicated for the child.	Baseline and week 9
Conners-3 Questionnaire	Measure of ADHD symptoms reported by the parent. The scale ranges from 0 to 3 with 0 equaling not true at all and 3 equaling very much true. The Conners t-score range from 0 - 100. The higher the number, the worse the outcome.	Change between baseline and week 9
Teacher Vanderbilt	Pre and Post measures of ADHD symptoms reported by the teacher. The measure items' scale ranges from 0 to 3, with 0 equaling never and 3 equaling very often. The Inattention outcome measure reported is the average number of items (symptoms) in the Inattention Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Inattention sub-scale, and the range of Inattention Symptoms reported by the teacher is 0-9. The Hyperactive/Impulsive outcome measure reported is the average number of items (symptoms) in the Hyperactive/Impulsive Sub-scale of the Vanderbilt that teachers rated their students as 2 or higher on the 0-3 scale. There are 9 items in the Hyperactive/Impulsive sub-scale, and the range of Hyperactive/Impulsive Symptoms reported by the teacher is 0-9.The higher the number, the more symptoms teachers are reporting.	Baseline and week 9

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Pooja Tandon, MD, Seattle Children's; Principal Investigator: Erin Gonzalez, MD, Seattle Children's

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): January 21, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; ADHD; Mobile Health; Behavioral Management Training
• Other Study ID Numbers: STUDY00001046; R21AT010041-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No