Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder

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Overseen ByLeslie K Taylor, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist Latino children who have experienced trauma and exhibit signs of Post-Traumatic Stress Disorder (PTSD). It employs a personalized therapy called Stepped Care Cognitive Behavioral Therapy, involving both the child and their caregiver in structured sessions. The researchers aim to determine if this personalized approach improves outcomes compared to standard trauma-focused therapy. Families with children aged 7 to 12 who have shown PTSD symptoms after a traumatic event and speak English or Spanish may be suitable for this trial. As an unphased trial, it offers families the chance to contribute to innovative research that could influence future PTSD treatments for children.

Will I have to stop taking my current medications?

The trial requires that children must be stable on their current psychotropic medications for at least 4 weeks, and for benzodiazepines or stimulants, they must be stable for at least 2 weeks. If your child is not stable on these medications for the required time, they will not be eligible to participate.

What prior data suggests that this therapy is safe for children with PTSD?

Research has shown that Cognitive Behavioral Therapy (CBT) methods, such as Personalized Stepped Care CBT for Children after Trauma (pSC-CBT-CT), are generally well-received by children who have experienced trauma. This therapy helps children manage stress and anxiety by changing their thoughts and behaviors.

In previous studies, children responded positively to this treatment, with few negative effects reported. The therapy begins with gentle sessions and gradually intensifies if needed, ensuring it meets each child's needs.

The therapy's design supports its safety by involving caregivers and therapists, making it a gentle approach for children. While all therapies can have some side effects, this one aims to reduce them by tailoring the treatment to each child.12345

Why are researchers excited about this trial?

Researchers are excited about Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) because it offers a tailored approach to treating PTSD in children, incorporating cultural values and beliefs specific to Latino communities. Unlike standard treatments, pSC-CBT-CT involves a unique two-step process that starts with caregiver-led sessions supported by therapists and progresses to more intensive trauma-focused therapy with gradual exposure. This method empowers caregivers to be directly involved in the healing process, potentially enhancing the child's recovery through culturally relevant and personalized care.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) effectively treats childhood post-traumatic stress disorder (PTSD). In this trial, participants will receive a personalized version of SC-CBT-CT tailored for Latino families, incorporating cultural values to potentially enhance its effectiveness. Studies have found that this method can reduce symptoms and is cost-efficient by actively involving caregivers. Early results suggest that when caregivers manage their own stress, they can assist their children with therapy tasks, such as creating a story about the trauma and gradually facing fears. Overall, SC-CBT-CT shows promise in reducing PTSD symptoms in children through a structured, step-by-step approach with caregiver support.15678

Who Is on the Research Team?

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Leslie K Taylor, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children aged 7-12 who have experienced trauma after turning 3 years old and show at least five PTSD symptoms. Both child and guardian must agree on the traumatic event, be willing to participate, and can speak English or Spanish. Children with suicidal thoughts but no active plan can join with safety measures in place.

Inclusion Criteria

* parent and child agree that the target event/index trauma occurred;
I experience at least five symptoms of PTSD, including re-experiencing or avoidance.
* suicidal ideation does not exclude as long as there is no active plan/intent. Safety planning implemented and continued assessment for plan/intent;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step One Intervention

Caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy over 6-9 weeks

6-9 weeks
3 therapist-led caregiver-child meetings, weekly phone support

Step Two Intervention

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) with gradual exposure

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Assessments at week 7 and week 15

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)

Trial Overview

The study tests a personalized version of Stepped Care CBT (pSC-CBT-CT) against usual treatments for childhood PTSD. It starts with less intense therapy sessions that increase if needed, involving caregivers in the process to help Latino families specifically.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)Experimental Treatment1 Intervention
Group II: Treatment as Usual (TAU)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Texas Child Mental Health Care Consortium

Collaborator

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

University of South Florida

Collaborator

Trials
433
Recruited
198,000+

University of Houston

Collaborator

Trials
155
Recruited
48,600+

Citations

Stepped Care Cognitive Behavioral Therapy for Children ...

Children who have been exposed to a traumatic event may experience posttraumatic stress disorder (PTSD). Estimates of childhood PTSD range from 16% to 33% and ...

Stepped Care Cognitive Behavioral Therapy for Children after ...

Task shifting within a stepped care intervention to treat childhood posttraumatic stress disorder (PTSD) is an efficient, low-cost method, ...

Increasing Treatment Access in Trauma Exposed Children ...

TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent ...

Parent-led stepped care for traumatised children - PMC - NIH

The current study is the first to examine predictors of non-completion and non-response of the parent-led Step One of SC-CBT-CT conducted by a research group ...

Development of Stepped Care Trauma-Focused Cognitive ...

Preliminary evidence from two case reports suggests that as long as parents can manage their posttraumatic stress symptoms sufficiently to complete the trauma- ...

NCT02537678 | Stepped Care for Children After Trauma: ...

The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment ...

Personalized Cognitive Behavioral Therapy for Post ...

The study tests an adapted Cognitive Behavioral Therapy called pSC-CBT-CT, which starts with less intense sessions and increases in intensity if ...

Stepped care involving cognitive behavioral therapy for young ...

Early intervention for psychosis is associated with better clinical outcomes. The clinical high-risk for psychosis (CHRP) state is ...