Status:
COMPLETED
Lifestyle Enhancement for ADHD Program 2
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
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 manageme...
Detailed Description
This is a randomized trial comparing the LEAP program to standard BMT for ADHD (without the enhanced focus on health behaviors, mHealth technology, or social media). Specifically, 80 families will be ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (child):
- Age 6-10 years
- ADHD diagnosis
- CGI-S rating ranging from 4 to 7.
- Child not wearing a wrist-worn activity tracker more than 50% of days in the past month
- Inclusion Criteria (caregiver):
- One adult custodial caregiver (resides with the child at least 50% of the time) 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
- Inclusion Criteria (supplementary caregiver):
- An additional caregiver designated by the participating caregiver who provides care for the participating child on at least one occasion every other week
- Able to participate in one or more group sessions
- Able to consent in English
- Exclusion Criteria (children):
- \- Younger than 6 years old or older than 10 years old
- Do not meet criteria currently for ADHD diagnosis
- Meet diagnostic criteria for psychiatric co-morbidities of Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability (by history)
- Per caregiver report, engage in \>60 min/day of MVPA consistently for at least 5 days per week
- Any physical or medical restrictions on PA
- Child currently/previously used a wearable physical activity sensing device at least 50% of days in the past month
- Exclusion Criteria (caregiver):
- \- Caregiver participated in an evidence-based parent behavior management training program (i.e., Incredible Years, Triple P, PCIT, Barkley's Defiant Child) in the past 24 months.
- Exclusion Criteria (supplementary caregiver): none
Exclusion
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04779333
Start Date
September 9 2020
End Date
April 28 2023
Last Update
May 6 2023
Active Locations (1)
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1
Seattle Children's Research Institute
Seattle, Washington, United States, 98145