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Attention Deficit Hyperactivity DisorderLEAPNCT04779333

Lifestyle Enhancement for ADHD Program 2

A study testing LEAP and Standard BMT in people with Attention Deficit Hyperactivity Disorder, run by Seattle Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
LEAP and Standard BMT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
9 Sep 2020to 28 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • - 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Seattle Children's Research Institute

    Seattle, Washington, 98145

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
LEAP, Standard BMT
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEAPBehavioural

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

  • Standard BMTBehavioural

    Weekly BMT groups sessions which follow the Barkley curriculum

Study groups in NCT04779333
Study groupRoleWhat they receive
LEAP GroupExperimentalIn 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.
Receives: Behavioral: LEAP
BMT GroupActive comparatorThe 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.
Receives: Behavioral: Standard BMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effects of intervention on Physical Activity

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

    Measured: Baseline to 10 weeks

  2. Effects of intervention on Physical Activity

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

    Measured: Baseline to 20 weeks

  3. Effects of intervention on Physical Activity

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

    Measured: Baseline to 1 year

Secondary outcomes (6)

  1. 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

    Measured: Baseline to 10 weeks

  2. 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

    Measured: Baseline to 20 weeks

  3. 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

    Measured: Baseline to 1 year

  4. 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

    Measured: Baseline to 10 weeks

  5. 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

    Measured: Baseline to 20 weeks

  6. 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

    Measured: Baseline to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start9 Sep 2020
  3. Primary completion28 Apr 2023
  4. Study completion28 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04779333
Sponsor's protocol ID
STUDY00002356
Other IDs
R33AT010041
Acronym
LEAP
Status last verified
May 2023
First submitted
24 Feb 2021
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tandon PS, Gabert T, Kuhn M, Tran N, Ola C, Sullivan E, Zhou C, Stein M, Mendoza JA, Sasser T, Gonzalez E. Modernizing behavioral parent training program for ADHD with mHealth strategies, telehealth groups, and health behavior curriculum: a randomized pilot trial. J Pediatr Psychol. 2024 Sep 1;49(9):664-675. doi: 10.1093/jpepsy/jsae073.

    PubMed 39279226

Questions about this trial

What is this clinical trial studying?

A study testing LEAP and Standard BMT in people with Attention Deficit Hyperactivity Disorder, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of intervention on Physical Activity (time frame: Baseline to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04779333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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Lifestyle Enhancement for ADHD Program 2 (NCT04779333) | AzTrials