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

NCT07396935 | Not Yet Recruiting

• 1 other identifier: HSC-MS-25-0929 (Pilot)
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• 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

  Total score ranges from 0 to 73, with a higher score indicating worse symptoms.

  baseline, week 7, week 15

• Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported

  Total score ranges from 0 to 73, with a higher score indicating worse symptoms.

  baseline, week 7, week 15

• Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)

  Total score ranges from 0 to 65, with a higher score indicating a worse outcome.

  baseline, week 7, week 15

Secondary Outcomes (9)

• Number of participants with a PTSD Diagnosis as Assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders Child and Adolescent Version (DIAMOND-KID) Clinical Interview

  baseline, week 7, week 15

• Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore

  baseline, week 15

• Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore

  baseline, week 15

• Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale

  baseline, week 7, week 15

• Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale

  baseline, week 7, week 15

Study Arms (1)

Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

EXPERIMENTAL

The SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.

Behavioral: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

Interventions

Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) BEHAVIORAL

The SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.

Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Child Mental Health Care Consortium: collaborator
• Baylor College of Medicine: collaborator
• University of South Florida: collaborator
• University of Houston: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Leslie K Taylor, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie K Taylor, PhD

CONTACT

713-486-2728; psyc.steppedcarecbt@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)