Lifestyle Enhancement for ADHD Program 2 (LEAP)

May 2, 2023 updated by: Pooja Tandon, Seattle Children's Hospital

Lifestyle Enhancement for ADHD Program (LEAP) Study 2

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98145
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LEAP Group
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
LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.
Active Comparator: BMT Group
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
Weekly BMT groups sessions which follow the Barkley curriculum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of intervention on Physical Activity
Time Frame: Baseline to 10 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Baseline to 10 weeks
Effects of intervention on Physical Activity
Time Frame: Baseline to 20 weeks
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Baseline to 20 weeks
Effects of intervention on Physical Activity
Time Frame: Baseline to 1 year
Comparing within-subject pre to post activity (MVPA) using accelerometer data
Baseline to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of LEAP participation on child executive function
Time Frame: Baseline to 10 weeks
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Baseline to 10 weeks
Effects of LEAP participation on child executive function
Time Frame: Baseline to 20 weeks
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Baseline to 20 weeks
Effects of LEAP participation on child executive function
Time Frame: Baseline to 1 year
Evaluate effects of LEAP participation on the child's executive functioning using the parent reported BRIEF-2 measure
Baseline to 1 year
Effects of LEAP participation on child ADHD symptoms
Time Frame: Baseline to 10 weeks
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Baseline to 10 weeks
Effects of LEAP participation on child ADHD symptoms
Time Frame: Baseline to 20 weeks
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Baseline to 20 weeks
Effects of LEAP participation on child ADHD symptoms
Time Frame: Baseline to 1 year
Evaluate effects of LEAP participation on the child's ADHD symptoms using the Conners-3 Parent Rating Scale
Baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pooja Tandon, MD, Seattle Children's
  • Principal Investigator: Erin Gonzalez, PHD, Seattle Children's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002356
  • R33AT010041 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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