Lifestyle Enhancement for ADHD Program 2

NCT04779333 | Completed DMC

• 2 other identifiers: STUDY00002356R33AT010041
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 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

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• Effects of intervention on Physical Activity

  Comparing within-subject pre to post activity (MVPA) using accelerometer data

  Baseline to 10 weeks

• Effects of intervention on Physical Activity

  Comparing within-subject pre to post activity (MVPA) using accelerometer data

  Baseline to 20 weeks

• Effects of intervention on Physical Activity

  Comparing within-subject pre to post activity (MVPA) using accelerometer data

  Baseline to 1 year

Secondary Outcomes (6)

• Effects of LEAP participation on child executive function

  Baseline to 10 weeks

• Effects of LEAP participation on child executive function

  Baseline to 20 weeks

• Effects of LEAP participation on child executive function

  Baseline to 1 year

• Effects of LEAP participation on child ADHD symptoms

  Baseline to 10 weeks

• Effects of LEAP participation on child ADHD symptoms

  Baseline to 20 weeks

Study Arms (2)

LEAP Group

EXPERIMENTAL

In addition to the components of the BMT group, the LEAP program includes an emphasis on supporting optimal physical activity, limiting screen time, and encouraging adequate sleep. The child and caregiver are also given a wrist-worn activity tracker and caregivers participate in a motivational Facebook group.

Behavioral: LEAP

BMT Group

ACTIVE COMPARATOR

The BMT Group will take part in a family-based intervention within the context of evidence-based behavioral management training (BMT) for caregivers. Standard BMT represents the current standard of care for childhood ADHD.

Behavioral: Standard BMT

Interventions

LEAP BEHAVIORAL

LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker \& facebook group.

LEAP Group

Standard BMT BEHAVIORAL

Weekly BMT groups sessions which follow the Barkley curriculum

BMT Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• \- 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
• \- 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pooja Tandon, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Erin Gonzalez, PHD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: September 9, 2020
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)