Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04779333
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT04779333
Study Brief:
Protocol Section:
NCT04779333