Trauma-Focused Cognitive Behavioral Therapy for PTSD

(IDEA Trial)

Overseen By Sheree L Toth, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Cognitive limitations, Psychiatric condition, Physical disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) combined with socialization practices for children who have experienced abuse or neglect. The researchers aim to determine if adding socialization can better support mental health recovery for youth facing community-related stress. Participants will receive either standard TF-CBT or the enhanced version with socialization. This study suits children aged 10-15 with a history of maltreatment who are seeking services at a specific clinic. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance therapeutic approaches for child maltreatment recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators for more details.

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

Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) effectively treats children who have experienced trauma, such as abuse or neglect. TF-CBT reduces mental health issues like PTSD, depression, and stress.

Combining TF-CBT with Racial Socialization (RS), which helps young people understand and manage racial stress, appears to offer additional benefits. Studies indicate that adding RS to TF-CBT can be particularly beneficial for Black youth facing racial stress.

Previous studies report that both TF-CBT and the enhanced version with RS are generally well-received by participants. While specific side effects are rarely mentioned, the focus often remains on the positive effects on mental health. This suggests that the treatment is considered safe and effective for many participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Racial Socialization because it uniquely addresses PTSD by incorporating cultural and social elements into the therapeutic process. Unlike standard TF-CBT, which focuses primarily on trauma processing, this enhanced version integrates racial socialization, helping individuals navigate and make sense of racial and cultural experiences that may influence their trauma. This approach not only aims to treat PTSD symptoms but also empowers individuals by fostering a deeper understanding of their social identity, potentially leading to more comprehensive and enduring healing.

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

Research has shown that Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) reduces post-traumatic stress disorder (PTSD) symptoms in children. Studies have found that TF-CBT outperforms other treatments for children with these symptoms. In this trial, participants will receive either standard TF-CBT or TF-CBT enhanced with socialization components. Early results suggest that adding Racial Socialization (RS) to TF-CBT may further assist by addressing cultural and social challenges children face. This combination aims not only to reduce PTSD symptoms but also to improve coping skills in difficult situations. Overall, TF-CBT with RS appears promising for children needing support after trauma. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

The IDEA trial is for young individuals who have experienced child abuse and neglect (CAN) and are dealing with Post-Traumatic Stress Disorder (PTSD). It's especially focused on those from racially marginalized communities. The study seeks participants who may benefit from therapy that includes coping strategies for racial stress.

Inclusion Criteria

Youth with histories of child maltreatment as determined by screening positive on at least 1 child abuse or neglect item from the ACE scale completed by caregiver report and/or report of child abuse or neglect on the UCLA PTSD assessment tool completed independently by youth and caregivers.

I am a Black youth aged 10-14.

Exclusion Criteria

Severe psychiatric disorders requiring a higher level of care (e.g., imminent suicidal ideation requiring hospitalization, psychotic features)

Non-English proficiency

Foster care or residential placements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) with or without racial socialization components

6 months

12-25 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Racial Socialization (RS)

Trial Overview This trial tests Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), both in its standard form and augmented with Racial Socialization (RS) to address the specific needs of racially marginalized youth. It aims to find out if adding RS improves mental health outcomes.

How Is the Trial Designed?

Group I: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization Experimental Treatment 2 Interventions

TF-CBT will be implemented enhanced with socialization components

Group II: Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) Active Control 1 Intervention

TF-CBT will be administered as typically implemented at Pediatric Behavioral Health and Wellness outpatient clinic

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

Trauma-focused cognitive behavioral therapy (TF-CBT) has been shown to be effective in treating trauma-related symptoms and improving psychosocial functioning in children and adolescents affected by conflict in low- and middle-income countries, based on a systematic review of 11 studies involving 1,354 participants.

Most studies were conducted in low-resource settings in East or Central Africa, where cultural adaptations were made to the TF-CBT delivery, highlighting the importance of tailoring interventions to meet local needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. Thomas, FC., Puente-Duran, S., Mutschler, C., et al.[2022]

Trauma-focused cognitive behavioral therapy (TFCBT) is generally accepted by asylum-seekers with PTSD, with most participants finding it helpful despite the challenges they faced during treatment.

Fear of repatriation can hinder engagement in TFCBT, highlighting the importance of a strong therapeutic relationship to support asylum-seekers in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asylum-seekers' experiences of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder: a qualitative study. Vincent, F., Jenkins, H., Larkin, M., et al.[2018]

A mobile phone-delivered serious game designed to enhance trauma-focused cognitive behavioral therapy (TF-CBT) for PTSD was found to be acceptable to both patients and clinicians, indicating potential for improved treatment engagement.

Both service users and clinicians suggested that the game should be therapist-guided and acknowledged that it may not be suitable for all patients, emphasizing the need for careful prescription by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

Out of 263,018 patients diagnosed with PTSD between 2017 and 2019, only 11.6% initiated evidence-based psychotherapies (EBPs) within their first year, highlighting a significant gap in treatment engagement.

Factors such as older age and comorbid mental health conditions were associated with lower rates of initiating EBPs, while those reporting military sexual trauma (MST) were more likely to start treatment, indicating the need to address disparities in access to effective PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated with Engaging in Evidence-Based Psychotherapy During the First Year of Posttraumatic Stress Disorder Treatment Between 2017 and 2019. Cameron, D., Shiner, B., O'Neill, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4396183/

Trauma-Focused Cognitive Behavioral Therapy: Assessing ... TF-CBT has demonstrated positive outcomes in reducing symptoms of posttraumatic stress disorder, although it is less clear whether TF-CBT is effective in ...

2. tfcbt.org tfcbt.org/tf-cbt-and-racial-socialization/

TF-CBT and Racial Socialization This manual addresses strategies for implementing Trauma‐Focused Cognitive Behavioral Therapy (TF-CBT+RS, Metzger, Dandridge, Cohen, & Mannarino, 2023) and ...

3. withpower.com withpower.com/trial/phase-stress-disorders-post-traumatic-6-2024-eb0a6

Trauma-Focused Cognitive Behavioral Therapy for PTSD What data supports the effectiveness of the treatment Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Racial Socialization (RS) for PTSD?

4. files.calio.org files.calio.org/BIBS/Trauma_focused_CBT_bib_NCAC06_251001.pdf

Trauma-Focused Cognitive Behavioral Therapy Subgroup analyses showed that group TF-CBT was superior to other treatments in studies including children with post-traumatic stress symptoms (PTSS) (SMD: -0.54 ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1077559517725403

A Pilot Study of Trauma-Focused Cognitive–Behavioral ... The present study is proof-of-concept pilot of trauma-focused cognitive–behavioral therapy (TF-CBT) delivered to underserved trauma-exposed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8673910/

Trauma-Focused Cognitive Behavioral Therapy in 13 ... In this pilot study, 31 clinicians in 13 urban public schools received TF-CBT training to improve access to a high-quality trauma treatment for youth in need.

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ps.201300255

Trauma-Focused Cognitive-Behavioral Therapy for ... TF-CBT was associated with lower levels of mental health symptoms (PTSD, depression, and general symptoms) and greater improvements in functional impairment, ...

8. researchprotocols.org researchprotocols.org/2025/1/e77762

Application of the ADAPT-ITT Model to Develop Trauma ... Objective: This study integrated racial socialization (RS)—a protective process for Black youth—into trauma-focused cognitive behavioral therapy ...