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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Patients
• Intervention / Treatment: Behavioral: PSC-TF-CBT

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Funlola G Are, PhD; Phone Number: (713) 486-2700; Email: Funlola.G.Are@uth.tmc.edu
• Study Contact Backup: Name: Kofoworola Bombata; Email: Kofoworola.Bombata@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Kofoworola Bombata; Email: Kofoworola.Bombata@uth.tmc.edu
      • Contact: Funlola G Are, PhD; Phone Number: 713-486-2700; Email: Funlola.G.Are@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• able to read or understand English

Exclusion Criteria:

• Currently receiving mental health treatment elsewhere

• Clinical exclusion criteria:

  1. Evidence of active suicidality
  2. Presence of psychotic symptoms

Severe psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as:

1. Score ≥ 40 on the child-report measure, or
2. Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PSC-TF-CBT

Behavioral: PSC-TF-CBT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)	This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms	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 )	This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms	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)	This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms	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)	This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms	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)	The Pediatric Symptom Checklist-17 (PSC-17) is a 17-item screening measure of psychosocial, emotional, and behavioral problems in children and adolescents. Each item is rated on a 3-point scale from 0 (Never) to 2 (Often). Item scores are summed to generate a Total Problems Score, ranging from 0 to 34, with higher scores indicating greater emotional and behavioral difficulties.	Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)	This is a 4-item implementation outcome measure rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Scores will be calculated by averaging item responses , with higher scores indicating greater perceived appropriateness.	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 as assessed by the Acceptability of Intervention Measure (AIM)	This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). The four item scores are averaged to generate an overall AIM score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.	6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
Feasibility as assessed by the Feasibility of Intervention Measure (FIM).	This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree) for a maximum score range of 1-20,with higher scores indicating greater perceived feasibility of the intervention.	6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: The Texas Child Mental Health Care Consortium (TCMHCC)
• Investigators: Study Director: Funlola G Are, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Behavioral Therapy; Trauma; pediatric primary care
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HSC-MS-26-0466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No