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NCT Number: NCT07797400

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

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

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Key information

Conditions

Trauma Patients Wounds and Injuries

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • able to read or understand English

Exclusion criteria

  • Currently receiving mental health treatment elsewhere
  • Clinical exclusion criteria:
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility as assessed by the number of participants recruited

    Time frame: From baseline to end of study (30 weeks form baseline)

  2. Feasibility as assessed by the number of participants enrolled in the study

    Time frame: end of study (30 weeks form baseline)

  3. Feasibility as assessed by the number of participants retained in the study

    Time frame: end of study (30 weeks form baseline)

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

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

    Time frame: From baseline to end of study (30 weeks form baseline)

  5. Feasibility as assessed by number of participants that completed the intervention

    Time frame: end of study (30 weeks from baseline)

  6. Change in acceptability by youth as assessed by participant satisfaction questionnaires

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

    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.

  7. Change in acceptability by caregiver as assessed by participant satisfaction questionnaires

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

    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

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

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

    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

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

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

    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

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

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

    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

Secondary outcomes

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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.

  6. Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)

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

    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.

  7. Change in acceptability as assessed by the Acceptability of Intervention Measure (AIM)

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

    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.

  8. Feasibility as assessed by the Feasibility of Intervention Measure (FIM).

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Funlola G Are, PhD

CONTACT

[email protected]

(713) 486-2700

Kofoworola Bombata

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The Texas Child Mental Health Care Consortium (TCMHCC)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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