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Lifestyle Enhancement for ADHD Program (LEAP)

Primary Purpose

ADHD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Enhancement for ADHD Program
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ADHD focused on measuring ADHD, Physical Activity, Behavioral Management Training, Mobile Health

Eligibility Criteria

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

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

Sites / Locations

  • Seattle Children's Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Enhancement for ADHD Program

Arm Description

There is no comparison/control arm.

Outcomes

Primary Outcome Measures

Moderate to Vigorous Physical Activity (MVPA)
Measured by accelerometer worn by participating children
Garmin Wear Time
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Number of Facebook Posts
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Number of Caregivers With Attendance at the Focus Group
Attendance will be taken at the focus group as a measure of study acceptability

Secondary Outcome Measures

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.
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.
Finger Windows (FW) Task
Measure of executive function completed by the child
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 18, 2018
Last Updated
March 24, 2022
Sponsor
Seattle Children's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03690674
Brief Title
Lifestyle Enhancement for ADHD Program
Acronym
LEAP
Official Title
Lifestyle Enhancement for ADHD Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Physical Activity, Behavioral Management Training, Mobile Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Enhancement for ADHD Program
Arm Type
Experimental
Arm Description
There is no comparison/control arm.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Enhancement for ADHD Program
Other Intervention Name(s)
LEAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Moderate to Vigorous Physical Activity (MVPA)
Description
Measured by accelerometer worn by participating children
Time Frame
Baseline (measured prior to week 1 of Treatment Group) and week 9
Title
Garmin Wear Time
Description
The length of time (in days) each participant wore the Garmin device as a measure of feasibility
Time Frame
Weeks 1 - 9
Title
Number of Facebook Posts
Description
The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
Time Frame
Weeks 1 - 9
Title
Number of Caregivers With Attendance at the Focus Group
Description
Attendance will be taken at the focus group as a measure of study acceptability
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Stop Signal Reaction Time (SSRT) Task Score
Description
Measure of executive function completed by the child. Score is time in ms for participant to respond. Lower score is better.
Time Frame
Baseline to week 9
Title
Digit Span (DS) Task - Total Score
Description
Measure of executive function completed by the child. Digit Span Task. Minimum score: 0; Maximum score: 54. Higher score is better outcome.
Time Frame
Baseline to week 9
Title
Finger Windows (FW) Task
Description
Measure of executive function completed by the child
Time Frame
Change between baseline and week 9
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
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.
Time Frame
Change between baseline and week 9
Title
Impairment Rating Scale (IRS)
Description
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.
Time Frame
Change between baseline and week 9
Title
Alabama Parenting Questionnaire (APQ)
Description
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.
Time Frame
Change between baseline and week 9
Title
Health Behaviors Survey
Description
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.
Time Frame
Baseline and week 9
Title
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Description
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.
Time Frame
Baseline and week 9
Title
Conners-3 Questionnaire
Description
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.
Time Frame
Change between baseline and week 9
Title
Teacher Vanderbilt
Description
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.
Time Frame
Baseline and week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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, MD
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

Plan to Share IPD
No

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