Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)

Starting soon · Not applicable

Conditions studied: Trauma, Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT07396974

Run by

The University of Texas Health Science Center, Houston

People needed

30

Starts

2026-09-01

Expected to finish

2027-08-31

Last updated by the study team

2026-02-09

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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