TraumaNCT07396974
Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)
A study testing Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) and Treatment as Usual (TAU) in people with Trauma and Posttraumatic Stress Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Posttraumatic Stress Disorder
- What is being tested?
- Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) and Treatment as Usual (TAU)
- 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
- 1 Sep 2026to 31 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
Leslie K Taylor, PhD, 713-486-2728, psyc.steppedcarecbt@uth.tmc.edu
About this study
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
- Being tested
- Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT), Treatment as Usual (TAU)
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)Behavioural
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.
Treatment as Usual (TAU)Behavioural
Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) |
| Treatment as Usual (TAU) | Active comparator | Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
A PTSD diagnosis using the DIAMOND-KID Clinical Interview is indicated by answering "yes" to the presence of 4 types of PTSD symptoms.
Measured: baseline, week 7, week 15
Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore
Total score ranges from 0 to 111, with a higher score indicating greater symptom severity.
Measured: baseline, week 15
Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore
Total score ranges from 0 to 30, with a higher score indicating greater symptom severity.
Measured: baseline, week 15
Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale
Total score ranges from 0 (no illness) to 6 (extremely severe), with a higher score indicating a greater severity of trauma symptoms.
Measured: baseline, week 7, week 15
Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale
Total score ranges from 0 to 7, with a higher score indicating a worse outcome. A score of 1, 2 or 3 will be used to indicate treatment response.
Measured: baseline, week 7, week 15
Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5)
Total score ranges from 0 to 80, with a higher score indicating a worse outcome.
Measured: baseline, week 15
Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Total score ranges from 0 to 27, with a higher score indicating a worse outcome.
Measured: baseline, week 15
Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale
Total score ranges from 0 to 21, with a higher score indicating a worse outcome.
Measured: baseline, week 15
Parent Stress as Assessed by the Perceived Stress Scale (PSS)
Scores range from 18 to 90, with a higher score indicating higher parenting stress.
Measured: baseline, week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Child Mental Health Care Consortium, Baylor College of Medicine, University of South Florida, University of Houston
- Responsible party
- Principal investigator, Leslie Taylor, The University of Texas Health Science Center, Houston
- Investigators
- Leslie K Taylor, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396974
- Sponsor's protocol ID
- HSC-MS-25-0929 (RCT)
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)
- ClinicalTrials.gov ID
- NCT07396974
- Acronym / sponsor ID
- HSC-MS-25-0929 (RCT)
- Conditions
- Trauma, Posttraumatic Stress Disorder
- 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
- Texas Child Mental Health Care Consortium, Baylor College of Medicine, University of South Florida, University of Houston
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) | Experimental | Behavioral: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)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. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual (TAU)Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)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. | Behavioural | Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) |
| Treatment as Usual (TAU)Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
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
Time frame: baseline, week 7, week 15
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported
Time frame: baseline, week 7, week 15
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)
Time frame: baseline, week 7, week 15
Total score ranges from 0 to 65, with a higher score indicating a worse outcome.
9 secondary outcomes
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
Time frame: baseline, week 7, week 15
Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore
Time frame: baseline, week 15
Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore
Time frame: baseline, week 15
Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale
Time frame: baseline, week 7, week 15
Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale
Time frame: baseline, week 7, week 15
Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: baseline, week 15
Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, week 15
Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale
Time frame: baseline, week 15
Parent Stress as Assessed by the Perceived Stress Scale (PSS)
Time frame: baseline, week 15
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 9 Feb 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.
Leslie K Taylor, PhD principal investigator
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 Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) and Treatment as Usual (TAU) in people with Trauma and Posttraumatic Stress Disorder, 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 7 inclusion and 9 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 9 Feb 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 Leslie K Taylor, PhD (713-486-2728, psyc.steppedcarecbt@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline, week 7, week 15). The study lists 3 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 9 Feb 2026.