Trauma PatientsNCT07797400
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
A study testing PSC-TF-CBT in people with Trauma Patients, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Trauma Patients
- What is being tested?
- PSC-TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- able to read or understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kofoworola Bombata contact
United States1 site
The University of Texas Health science Center at Houston
Houston, Texas, 77030
Funlola G Are, PhD, 713-486-2700, Funlola.G.Are@uth.tmc.edu
Kofoworola Bombata, Kofoworola.Bombata@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Trauma Patients
- Being tested
- PSC-TF-CBT
- Keywords
- Cognitive Behavioral Therapy, Trauma, pediatric primary care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSC-TF-CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PSC-TF-CBT | Experimental | Not described Receives: Behavioral: PSC-TF-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by the number of participants recruited
Measured: From baseline to end of study (30 weeks form baseline)
Feasibility as assessed by the number of participants enrolled in the study
Measured: 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.
Measured: end of study (30 weeks form baseline)
Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant
Measured: From baseline to end of study (30 weeks form baseline)
Feasibility as assessed by number of participants that completed the intervention
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Texas Child Mental Health Care Consortium (TCMHCC)
- Responsible party
- Principal investigator, Funlola Are, The University of Texas Health Science Center, Houston
- Investigators
- Funlola G Are, Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797400
- Sponsor's protocol ID
- HSC-MS-26-0466
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy to Reduce Trauma Symptoms and Negative Mental Health Sequelae
- ClinicalTrials.gov ID
- NCT07797400
- Acronym / sponsor ID
- HSC-MS-26-0466
- Conditions
- Trauma Patients
- Keywords
- Cognitive Behavioral Therapy, Trauma, pediatric primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Texas Child Mental Health Care Consortium (TCMHCC)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSC-TF-CBT | Experimental | Behavioral: PSC-TF-CBT |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- able to read or understand English
Key exclusion criteria (7 listed)
- Currently receiving mental health treatment elsewhere
- Clinical exclusion criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSC-TF-CBTThe 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. | Behavioural | PSC-TF-CBT |
Primary outcome
Feasibility as assessed by the number of participants recruited
Time frame: From baseline to end of study (30 weeks form baseline)
Feasibility as assessed by the number of participants enrolled in the study
Time frame: end of study (30 weeks form baseline)
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.
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)
Feasibility as assessed by number of participants that completed the intervention
Time frame: end of study (30 weeks from baseline)
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.
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
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
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
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
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kofoworola Bombata contact
Funlola G Are study director
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSC-TF-CBT in people with Trauma Patients, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Funlola G Are, PhD ((713) 486-2700, Funlola.G.Are@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the number of participants recruited (time frame: From baseline to end of study (30 weeks form baseline)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.