Lifestyle Enhancement for ADHD Program

Not Applicable

Completed

Conditions: ADHD

Interventions: Behavioral: Lifestyle Enhancement for ADHD Program

Registration Number: NCT03690674

Lead Sponsor: Seattle Children's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle Enhancement for ADHD Program	Lifestyle Enhancement for ADHD Program	There is no comparison/control arm.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Alabama Parenting Questionnaire (APQ)	Change between baseline and week 9	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.
Stop Signal Reaction Time (SSRT) Task Score	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.
Behavior Rating Inventory of Executive Function (BRIEF)	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.
Health Behaviors Survey	Baseline and week 9	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.
Digit Span (DS) Task - Total Score	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.
Impairment Rating Scale (IRS)	Change between baseline and week 9	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.
Finger Windows (FW) Task	Change between baseline and week 9	Measure of executive function completed by the child
Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)	Baseline and week 9	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	Change between baseline and week 9	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	Baseline and week 9	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.