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Completed

NCT Number: NCT03690674

Lifestyle Enhancement for ADHD Program

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Enhancement for ADHD Program

Behavioral

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: LEAP

Primary outcomes

  1. Moderate to Vigorous Physical Activity (MVPA)

    Time frame: Baseline (measured prior to week 1 of Treatment Group) and week 9

    Measured by accelerometer worn by participating children

  2. Garmin Wear Time

    Time frame: Weeks 1 - 9

    The length of time (in days) each participant wore the Garmin device as a measure of feasibility

  3. Number of Facebook Posts

    Time frame: Weeks 1 - 9

    The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility

  4. Number of Caregivers With Attendance at the Focus Group

    Time frame: Week 9

    Attendance will be taken at the focus group as a measure of study acceptability

Secondary outcomes

  1. 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.

  2. 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.

  3. Finger Windows (FW) Task

    Time frame: Change between baseline and week 9

    Measure of executive function completed by the child

  4. 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.

  5. Impairment Rating Scale (IRS)

    Time frame: 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.

  6. Alabama Parenting Questionnaire (APQ)

    Time frame: 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.

  7. Health Behaviors Survey

    Time frame: 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.

  8. Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)

    Time frame: 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.

  9. Conners-3 Questionnaire

    Time frame: 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.

  10. Teacher Vanderbilt

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: LEAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 1, 2018
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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