- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690674
Lifestyle Enhancement for ADHD Program (LEAP)
March 24, 2022 updated by: Pooja Tandon, Seattle Children's Hospital
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98145
- Seattle Children's Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Enhancement for ADHD Program
There is no comparison/control arm.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate to Vigorous Physical Activity (MVPA)
Time Frame: Baseline (measured prior to week 1 of Treatment Group) and week 9
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Measured by accelerometer worn by participating children
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Baseline (measured prior to week 1 of Treatment Group) and week 9
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Garmin Wear Time
Time Frame: Weeks 1 - 9
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The length of time (in days) each participant wore the Garmin device as a measure of feasibility
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Weeks 1 - 9
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Number of Facebook Posts
Time Frame: Weeks 1 - 9
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The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility
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Weeks 1 - 9
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Number of Caregivers With Attendance at the Focus Group
Time Frame: Week 9
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Attendance will be taken at the focus group as a measure of study acceptability
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Week 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stop Signal Reaction Time (SSRT) Task Score
Time Frame: Baseline to week 9
|
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
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Digit Span (DS) Task - Total Score
Time Frame: Baseline to week 9
|
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
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Finger Windows (FW) Task
Time Frame: Change between baseline and week 9
|
Measure of executive function completed by the child
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Change between baseline and week 9
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Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: Change between baseline and week 9
|
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.
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Change between baseline and week 9
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Impairment Rating Scale (IRS)
Time Frame: Change between baseline and week 9
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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.
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Change between baseline and week 9
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Alabama Parenting Questionnaire (APQ)
Time Frame: Change between baseline and week 9
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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.
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Change between baseline and week 9
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Health Behaviors Survey
Time Frame: Baseline and week 9
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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.
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Baseline and week 9
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Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)
Time Frame: Baseline and week 9
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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.
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Baseline and week 9
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Conners-3 Questionnaire
Time Frame: Change between baseline and week 9
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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.
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Change between baseline and week 9
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Teacher Vanderbilt
Time Frame: Baseline and week 9
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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.
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Baseline and week 9
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pooja Tandon, MD, Seattle Children's
- Principal Investigator: Erin Gonzalez, MD, Seattle Children's
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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