NCT03690674

Brief Summary

The purpose of this study is to investigate if physical activity (PA) can increase in children with Attention Deficit/Hyperactivity Disorder (ADHD) using a modified behavioral management training (BMT) program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 21, 2022

Completed
Last Updated

April 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

September 18, 2018

Results QC Date

July 4, 2021

Last Update Submit

March 24, 2022

Conditions

ADHD

Keywords

ADHDPhysical ActivityBehavioral Management TrainingMobile Health

Outcome Measures

Primary Outcomes (4)

  • Moderate to Vigorous Physical Activity (MVPA)

    Measured by accelerometer worn by participating children

    Baseline (measured prior to week 1 of Treatment Group) and week 9

  • Garmin Wear Time

    The length of time (in days) each participant wore the Garmin device as a measure of feasibility

    Weeks 1 - 9

  • Number of Facebook Posts

    The amount of contribution to the Facebook page (comments, likes, etc) by each participant is a measure of feasibility

    Weeks 1 - 9

  • Number of Caregivers With Attendance at the Focus Group

    Attendance will be taken at the focus group as a measure of study acceptability

    Week 9

Secondary Outcomes (10)

  • Stop Signal Reaction Time (SSRT) Task Score

    Baseline to week 9

  • Digit Span (DS) Task - Total Score

    Baseline to week 9

  • Finger Windows (FW) Task

    Change between baseline and week 9

  • Behavior Rating Inventory of Executive Function (BRIEF)

    Change between baseline and week 9

  • Impairment Rating Scale (IRS)

    Change between baseline and week 9

  • +5 more secondary outcomes

Study Arms (1)

Lifestyle Enhancement for ADHD Program

EXPERIMENTAL

There is no comparison/control arm.

Behavioral: Lifestyle Enhancement for ADHD Program

Interventions

Lifestyle Enhancement for ADHD ProgramBEHAVIORAL

The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.

Also known as: LEAP
Lifestyle Enhancement for ADHD Program

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 5-10 years
  • ADHD diagnosis
  • CGI-S rating \>4 and \<7
  • Per caregiver report, engage in \<60 min/day of MVPA for at least 5 days per week
  • One adult caregiver 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

You may not qualify if:

  • younger than 5 years old or older than 10 years old
  • do not meet criteria for ADHD diagnosis
  • Meet diagnostic criteria for psychiatric co-morbidities including Autism Spectrum Disorder, Depressive Disorder, Mood Disorder, Psychotic Disorder, or Intellectual Disability that could interfere with intervention uptake
  • Per caregiver report, engage in \>60 min/day of MVPA for at least 5 days per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98145, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Activity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Results Point of Contact

Title
Dr. Pooja Tandon
Organization
Seattle Children's Research Institute
pooja.tandon@seattlechildrens.org
206-884-1130

Study Officials

  • Pooja Tandon, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Erin Gonzalez, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2018

First Posted

October 1, 2018

Study Start

November 15, 2018

Primary Completion

December 9, 2019

Study Completion

January 21, 2020

Last Updated

April 21, 2022

Results First Posted

April 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)