Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Interventi… (NCT07396974) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)
United States30 participantsStarted 2026-09-01
Plain-language summary
One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.
Who can participate
Age range
7 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index (RI) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (UCLA-RI-5) - Child Reported
Timeframe: baseline, week 7, week 15
2
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported
Timeframe: baseline, week 7, week 15
3
Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)
Timeframe: baseline, week 7, week 15
Trial details
NCT IDNCT07396974
SponsorThe University of Texas Health Science Center, Houston