Lifestyle Enhancement for ADHD Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle Enhancement for ADHD Program

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Lifestyle Enhancement for ADHD Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Enhancement for ADHD Program<br>There is no comparison/control arm. | Behavioral: Lifestyle Enhancement for ADHD Program<br>* 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.<br>* Other names: LEAP;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Physical Activity, Behavioral Management Training, Mobile Health