Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy (PSC-TF-CBT)to Reduce Trauma Symptoms and Negative Mental Health Sequelae

NCT07797400 | Not Yet Recruiting DMC

• 1 other identifier: HSC-MS-26-0466
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluating the feasibility of delivering a trauma-focused intervention among children with elevated traumatic stress symptoms in primary care

Conditions

Trauma Patients

Keywords

Cognitive Behavioral Therapy; Trauma; pediatric primary care

Outcome Measures

Primary Outcomes (10)

• Feasibility as assessed by the number of participants recruited

  From baseline to end of study (30 weeks form baseline)

• Feasibility as assessed by the number of participants enrolled in the study

  end of study (30 weeks form baseline)

• Feasibility as assessed by the number of participants retained in the study

  Retained is described as participants who enroll in the study and remain enrolled through the study endpoint/final.

  end of study (30 weeks form baseline)

• Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant

  From baseline to end of study (30 weeks form baseline)

• Feasibility as assessed by number of participants that completed the intervention

  end of study (30 weeks from baseline)

• Change in acceptability by youth as assessed by participant satisfaction questionnaires

  Satisfaction will be assessed using a 10-item questionnaire. Participants will respond to each item with either "Agree" or "Disagree." The total number of "Agree" responses will be calculated, resulting in a total score ranging from 0 to 10. A higher number of "Agree" responses indicates greater satisfaction.

  6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in acceptability by caregiver as assessed by participant satisfaction questionnaires

  This is a 13 item questionnaire and each is scored from 1(very dissatisfied) to 7 (Very satisfied) for a score range of 13-91, higher scores indicating better outcome

  6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in acceptability of the intervention by the youth as assessed by qualitative exit interviews

  This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome

  6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in acceptability of the intervention by the caregiver as assessed by qualitative exit interviews

  This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome

  6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Child traumatic stress symptoms as assessed by the Child Trauma Screen (CTS)

  This is a 10 item questionnaire divided into 2 components: Four items assess exposure to potentially traumatic events using a yes/no response format, and six items assess PTSD-related reactions using a 4-point response scale scored from 0 to 3. The six reaction items are summed to produce a Reactions Total score ranging from 0 to 18, with higher scores indicating greater traumatic stress symptom severity. A Reactions Total score of ≥6 indicates a high likelihood of clinically significant PTSD symptoms

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

Secondary Outcomes (8)

• Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), (parent report )

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (child's self-report)

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (parent report)

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

• Change in emotional and behavioral problems as assessed by the Pediatric Symptom Checklist-17 (PSC-17)

  Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

Study Arms (1)

PSC-TF-CBT

EXPERIMENTAL

Behavioral: PSC-TF-CBT

Interventions

PSC-TF-CBT BEHAVIORAL

The intervention is a stepped-care adaptation of Trauma-Focused Cognitive Behavioral Therapy (PSC-TF-CBT) delivered within pediatric primary care. Treatment intensity is matched to each participant's individual clinical needs, with participants receiving lower-intensity intervention components initially and progressing to more intensive trauma-focused treatment as clinically indicated. PSC-TF-CBT incorporates trauma-focused cognitive behavioral therapy strategies for youth and includes caregiver involvement.

PSC-TF-CBT

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• able to read or understand English

You may not qualify if:

• Currently receiving mental health treatment elsewhere
• Evidence of active suicidality
• Presence of psychotic symptoms
• Severe psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as:
• Score ≥ 40 on the child-report measure, or
• Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The Texas Child Mental Health Care Consortium (TCMHCC): collaborator

Study Sites (1)

The University of Texas Health science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Funlola G Are

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

Central Study Contacts

Funlola G Are, PhD

CONTACT

(713) 486-2700; Funlola.G.Are@uth.tmc.edu

Kofoworola Bombata

CONTACT

Kofoworola.Bombata@uth.tmc.edu

Study Design

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

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)