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:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT04732806
Eligibility Criteria:
Inclusion:
* Age 8-12
* Insurance provided by Magellan Healthcare OR participant is covered by insurance in Massachusetts and has access to Explanation of Benefits information via online portal
* Has made a behavioral health claim in the past year
* MOAS score of greater than or equal to 2
* Evidence of ADHD, ODD, CD, DMDD, IED, or ASD by MINI-KID
* Parent or guardian is fluent in English
* WiFi at home (for Mightier tablet connection)
* Access to a computer or tablet in the home
Exclusion:
* IQ \< 70 (by medical record or clinician judgment)
* Extremely limited verbal capacity
* Change in medication or medication dosage in the past month or planned change in medication or medication dosage in the next month
* Active suicidal ideation
* History of suicide attempt and current depression
* Physical limitations that preclude the use of Mightier
* Sensory sensitivities that would preclude wearing an arm (or leg) heart rate monitor
* Evidence of psychosis, mania, alcohol use disorder, substance use disorder, or PTSD by MINI-Kid
* Ongoing or within the month prior to baseline visit placement in foster care or residential facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT04732806
Study Brief:
Protocol Section:
NCT04732806