Personalized 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 deliver therapy to Latino children who have experienced trauma, using Personalized Stepped Care Cognitive Behavioral Therapy (pSC-CBT-CT). The goal is to determine if personalizing the therapy process improves outcomes for children with post-traumatic stress disorder (PTSD). The therapy involves working with caregivers to support the child through structured sessions and activities. Children aged 7-12 who have experienced trauma and exhibit symptoms of PTSD may be suitable for this trial, especially if they speak English or Spanish. As an unphased trial, this study offers a unique opportunity to contribute to innovative therapy methods that could significantly enhance care for children with PTSD.

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 before participating. If your child is not stable on these medications, they will not be eligible for the trial.

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

Research shows that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is generally well-tolerated by children with PTSD. Studies on similar therapies, such as Stepped Care Cognitive Behavioral Therapy (SC-CBT), indicate they are safe for treating PTSD in children. This method involves fewer therapy sessions and includes the child's caregiver, which can make it more comfortable for kids.

These therapies have not been associated with major negative effects, suggesting they are safe options. Personalized versions of SC-CBT, like the one in this trial for Latino families, aim to adjust the therapy to meet specific cultural needs. While this customized approach is new, the basic therapies used are already considered safe.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 tailors therapy to incorporate specific cultural values and beliefs, particularly those of Latino communities. This personalized approach contrasts with standard Cognitive Behavioral Therapy (CBT), which generally follows a one-size-fits-all method. The treatment features a two-step process that begins with a caregiver-led phase, supported by therapists, and progresses to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), offering a more structured, supportive, and culturally sensitive way to address PTSD in children. By involving caregivers directly in the therapeutic process and utilizing home-based tasks, pSC-CBT-CT aims to create a more engaging and effective treatment environment.

What evidence suggests that personalized SC-CBT-CT is effective for PTSD?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively treats post-traumatic stress disorder (PTSD), providing both short-term and long-term benefits. In this trial, participants will receive a specific type of CBT called Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT), which is particularly beneficial. This method offers a personalized approach that adjusts based on the child's progress. It begins with a simpler treatment and can become more intensive if needed, making it suitable for each child's unique needs. By actively involving caregivers, the therapy aims to improve outcomes for children dealing with trauma. For Latino families, this therapy is customized to include cultural values and beliefs, potentially enhancing its effectiveness.16789

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 with trauma exposure who may have PTSD or related conditions. It's designed to help Latino families, and participants must be willing to engage in a personalized therapy program that involves their caregivers.

Inclusion Criteria

I am between 7-12 years old and have a guardian willing to participate.
I am fluent in English or Spanish.
My child was exposed to a traumatic event over 4 weeks ago.
See 4 more

Exclusion Criteria

Children with pervasive developmental disorders or Autism
Legal guardian or child with active psychosis
My legal guardian can understand and help me follow therapy instructions.
See 6 more

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

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

6 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 an adapted Cognitive Behavioral Therapy called pSC-CBT-CT, which starts with less intense sessions and increases in intensity if needed. The focus is on personalizing care for Latino children with trauma-related stress disorders.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)Experimental Treatment1 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+

University of Houston

Collaborator

Trials
155
Recruited
48,600+

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+

Citations

Increasing Treatment Access in Trauma Exposed Children ...

Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best ...

Cognitive behavioral therapy for the treatment of post ... - PMC

The current review suggests that CBT is an effective treatment for both acute and chronic PTSD, with both short-term and long-term benefit.

Systematic Review and Meta-Analysis of Stepped Care ...

A randomized controlled effectiveness trial of training strategies in cognitive processing therapy for posttraumatic stress disorder: Impact on patient outcomes ...

Effectiveness of stepped care for mental health disorders

This umbrella review synthesized existing meta-analyses on the effectiveness of stepped care for mental health disorders.

Stepped care for posttraumatic stress disorder

This pilot study tested the efficacy of combining a low-intensity program (This Way Up [TWU]) with the option to step up to an established higher intensity ...

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 ...

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

The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater ...

Personalized Cognitive Behavioral Therapy for Post ...

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

Full article: Stepping together for children after trauma

The study consists of three work-packages: WP1: Investigates (a) the effectiveness of ST-CT compared to therapy as usual (TAU) in reducing post-traumatic stress ...