Lifestyle Enhancement for ADHD Program 2

Attention Deficit Hyperactivity Disorder Clinical Trial

— LEAP  

Official title:

Lifestyle Enhancement for ADHD Program (LEAP) Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779333
• Other study ID #: STUDY00002356
• Secondary ID: R33AT010041
• Status: Completed
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: April 28, 2023

Study information

• Verified date: May 2023
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• LEAP
LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.
• Standard BMT
Weekly BMT groups sessions which follow the Barkley curriculum

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 10 weeks
Primary	Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 20 weeks
Primary	Effects of intervention on Physical Activity	Comparing within-subject pre to post activity (MVPA) using accelerometer data	Baseline to 1 year
Secondary	Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 10 weeks
Secondary	Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 20 weeks
Secondary	Effects of LEAP participation on child executive function	Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure	Baseline to 1 year
Secondary	Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 10 weeks
Secondary	Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 20 weeks
Secondary	Effects of LEAP participation on child ADHD symptoms	Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale	Baseline to 1 year