Seattle Children's Research Institute
Seattle, Washington, 98145, United States
NCT Number: NCT04779333
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 caregivers, enhanced with mobile health (mHealth) behavior change strategies.
Primary Objective: To evaluate the primary effects of a 9-week, family-based intervention (Lifestyle Enhancement for ADHD Program - LEAP) to promote PA in young children with ADHD
Secondary: To evaluate secondary effects of the LEAP program on child ADHD symptoms and executive functioning
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Notify Me6 year–10 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98145, United States
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 randomized to receive either LEAP or a standard BMT program based on Russell Barkley's Defiant Children intervention manual. Moderators (e.g., child sex, medication, BMI) and mediators (e.g., change in PA) will be analyzed as exploratory outcomes. Hypotheses being tested include: 1) LEAP will be successful in increasing PA in children with ADHD in the short-term and over a year, more so than standard BPT and 2) children randomized to LEAP will exhibit greater and more sustained improvement in clinical outcomes relative to standard BMT. If successful, the R33 phase will inform the development of a larger and longer, confirmatory trial.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(child):
Inclusion criteria
(caregiver):
Inclusion criteria
(supplementary caregiver):
Exclusion criteria
(children):
Exclusion criteria
(caregiver):
Exclusion criteria
(supplementary caregiver): none
LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.
Weekly BMT groups sessions which follow the Barkley curriculum
Time frame: Baseline to 10 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time frame: Baseline to 20 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time frame: Baseline to 1 year
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Time frame: Baseline to 10 weeks
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time frame: Baseline to 20 weeks
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time frame: Baseline to 1 year
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Time frame: Baseline to 10 weeks
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Time frame: Baseline to 20 weeks
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Time frame: Baseline to 1 year
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Seattle Children's Hospital
Other
Lifestyle Enhancement for ADHD Program (LEAP) Study 2
Acronym: LEAP
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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