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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07396935
Eligibility Criteria:
Inclusion Criteria:
* parent and child agree that the target event/index trauma occurred;
* report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);
* suicidal ideation does not exclude as long as there is no active plan/intent. Safety planning implemented and continued assessment for plan/intent;
* children ages 7-12 and a legal guardian willing to participate;
* can be fluent in English or Spanish;
* at least 4 weeks since child's exposure to one or more potentially traumatic events;
* trauma exposure occurred after child was 36 months old.
Exclusion Criteria:
* Children with pervasive developmental disorders or Autism;
* legal guardian or child with active psychosis;
* any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;
* children who have unsupervised visitation with their perpetrator;
* perpetrator (person that harmed child) is living in the home;
* active substance use disorder;
* child is currently receiving trauma-focused therapy;
* legal guardian is actively suicidal will be excluded from participation;
* children who have not been stable on psychotropic medication for 4 or more weeks, and/or for benzodiazepines/stimulants not stable for 2 or more weeks will not be eligible for the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
14 Years
Study:
NCT07396935
Study Brief:
Protocol Section:
NCT07396935