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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
35
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.
Seattle Children's Research Institute
Seattle, Washington, United States
Moderate to Vigorous Physical Activity (MVPA)
Measured by accelerometer worn by participating children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 9
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.
Time frame: 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.
Time frame: Baseline to week 9
Finger Windows (FW) Task
Measure of executive function completed by the child
Time frame: Change between baseline and week 9
Behavior Rating Inventory of Executive Function (BRIEF)
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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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and week 9