LEAP for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Seattle Children's Research Institute, Seattle, WAAttention Deficit Hyperactivity Disorder (ADHD)LEAP - Behavioral
Eligibility
6 - 10
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new program to help children with ADHD be more active, which may also help with their symptoms and executive functioning.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline to 1 year

Baseline to 1 year
Effects of LEAP participation on child ADHD symptoms
Effects of LEAP participation on child executive function
Effects of intervention on Physical Activity

Trial Safety

Trial Design

2 Treatment Groups

BMT Group
1 of 2
LEAP Group
1 of 2

Active Control

Experimental Treatment

88 Total Participants · 2 Treatment Groups

Primary Treatment: LEAP · No Placebo Group · N/A

LEAP Group
Behavioral
Experimental Group · 1 Intervention: LEAP · Intervention Types: Behavioral
BMT Group
Behavioral
ActiveComparator Group · 1 Intervention: Standard BMT · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LEAP
2016
N/A
~74160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 1 year

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
267 Previous Clinical Trials
5,186,415 Total Patients Enrolled
12 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,651 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Center for Complementary and Integrative Health (NCCIH)NIH
787 Previous Clinical Trials
657,354 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
139 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institutes of Health (NIH)NIH
2,469 Previous Clinical Trials
24,580,885 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
248 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Erin Gonzalez, PHDPrincipal InvestigatorSeattle Children's
Pooja Tandon, MDPrincipal Investigator - Seattle Children's
Seattle Children's Hospital
Brown University Program In Medicine (Medical School)
Children'S Hospital (Residency)
2 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
35 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age 6 - 10 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a moderate to severe level of illness, as assessed by a doctor using a rating scale called CGI-S.
You must be between 6 and 10 years old.
You are able to attend one or more group sessions.
If you're a child, you need to have worn a wrist-worn activity tracker for at least 50% of the days in the past month.
The caregiver has a smartphone or a device like a Garmin watch or iPod Touch that can be used during the study period.
You must be willing to download and share data from the Garmin smartphone app with the researchers.
You have a caregiver who helps take care of you and is available to participate in the study at least once every other week.

Who else is applying?

What state do they live in?
Indiana50.0%
Oregon50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Seattle Children's Research Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

Frequently Asked Questions

Does this clinical investigation admit participants aged 65 or over?

"This trial seeks to enroll children aged between 6 and 10. In addition, there are 108 trials for those under 18 years old and 35 available for individuals over 65." - Anonymous Online Contributor

Unverified Answer

Which demographic is able to partake in this experiment?

"This medical trial aims to recruit 80 young people, aged between 6 and 10 years of age, who have been diagnosed with ADHD. In order for potential participants to qualify they must meet the following criteria: have a CGI-S rating ranging from 4 to 7; attend one or more group sessions; not wear a wrist-worn activity tracker over 50% of days in the previous month; own/be willing to borrow an iPod Touch (or similar Garmin compatible device) during study period; agree to install and share data from their Garmin app with researchers; and provide contact details for an additional caregiver that provides care for the participating child at least" - Anonymous Online Contributor

Unverified Answer

Are researchers presently recruiting participants for this trial?

"Indeed, according to clinicaltrials.gov the investigation is actively recruiting patients with its initial post date set on 9th September 2020 and a recent update performed on 5th March 2022. This study requires 80 subjects at one location." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity for this clinical experiment?

"Absolutely, clinicaltrials.gov suggests that this medical trial is actively enrolling patients. It was initially posted on September 9th 2020 and most recently edited on May 3rd 2022. In total, 80 people will be recruited from a solitary site for the study's duration." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.