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Clinical Trials/NCT03690674
NCT03690674
Completed
Not Applicable

Lifestyle Enhancement for ADHD Program

Seattle Children's Hospital1 site in 1 country35 target enrollmentNovember 15, 2018
ConditionsADHD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
Seattle Children's Hospital
Enrollment
35
Locations
1
Primary Endpoint
Number of Facebook Posts
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
January 21, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pooja Tandon

Assistant Professor

Seattle Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

  • Alabama Parenting Questionnaire (APQ)(Change between baseline and week 9)
  • Stop Signal Reaction Time (SSRT) Task Score(Baseline to week 9)
  • Behavior Rating Inventory of Executive Function (BRIEF)(Change between baseline and week 9)
  • Health Behaviors Survey(Baseline and week 9)
  • Finger Windows (FW) Task(Change between baseline and week 9)
  • Digit Span (DS) Task - Total Score(Baseline to week 9)
  • Impairment Rating Scale (IRS)(Change between baseline and week 9)
  • Child's Sleep Habits Questionnaire (Pre-school and School-aged Children)(Baseline and week 9)
  • Conners-3 Questionnaire(Change between baseline and week 9)
  • Teacher Vanderbilt(Baseline and week 9)

Study Sites (1)

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