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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05160194
Eligibility Criteria:
Inclusion Criteria:
1. Age at injury and enrollment: ages 0-4, inclusive
2. Overnight hospitalization for traumatic brain injury
3. Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
4. Language: English must be the primary spoken language in the home
Exclusion Criteria:
1. Does not reside with the caregiver at least half-time
2. The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
3. English is not the primary language spoken in the home
4. Families of children who are non-responsive or in a persistent vegetative state will also be excluded
5. Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
6. If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
4 Years
Study:
NCT05160194
Study Brief:
Protocol Section:
NCT05160194