60 Participants Needed

Trauma-Focused Cognitive Behavioral Therapy for PTSD

(IDEA Trial)

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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

Research shows that group therapy can effectively reduce PTSD symptoms across different racial groups, and Cognitive Processing Therapy (a similar approach to TF-CBT) has been effective for both Black and White female veterans with military-related PTSD. This suggests that TF-CBT, especially when considering racial factors, could be beneficial for diverse populations.12345

Is Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) safe for treating PTSD?

The research suggests that Cognitive Processing Therapy (CPT), a form of trauma-focused therapy, is generally well-tolerated and safe for treating PTSD in veterans, regardless of race. While the studies focus on effectiveness, they imply that the therapy is safe as no significant safety concerns were reported.14567

How is Trauma-Focused Cognitive Behavioral Therapy with Racial Socialization different from other PTSD treatments?

This treatment is unique because it combines Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which is a well-established method for treating PTSD, with Racial Socialization (RS), which involves discussing and understanding racial identity and experiences. This combination aims to address both trauma and the specific cultural and racial experiences that may impact mental health, making it particularly relevant for individuals from diverse racial backgrounds.89101112

What is the purpose of this trial?

Resilient Roots is integrated into the TRANSFORM Center to promote translation of research findings into clinical interventions, to inform the next generation of research on child abuse and neglect (CAN), and to facilitate dissemination of research and practice knowledge/skills to varied stakeholders. Exposure to CAN frequently results in long-term detrimental effects on mental health. For youth who have experienced racial and ethnic marginalization, the trauma associated with CAN may be compounded by stress and trauma deriving from experiences of racism, discrimination, and other forms of oppression. Interventions to address racial stress for symptomatic youth receiving mental health services are lacking, and use of mental health services that are acceptable to Black families are too often misaligned with their representation in the population in general and overrepresentation in the child welfare system specifically. Incorporating support for families in enhancing racial socialization and coping skills specific to addressing racial stress and trauma has relevance for public health, where systemic racism is acknowledged as a core social determinant of health posing a threat to public health. Although Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based treatment for children who have experienced CAN, determining best practices for implementing enhanced TF-CBT with racial socialization components is urgently needed to address these gaps and provide optimal intervention for this population. Resilient Roots is a pilot study within a RE-AIM/PRISM framework (including Reach, Effectiveness, Adoption, Implementation, and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting) that will incorporate stakeholder perspectives and evaluate the incorporation of racial socialization into TF-CBT, while identifying barriers and facilitators to implementation to guide future larger-scale trials.

Eligibility Criteria

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

I am a Black youth aged 10-14.
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.

Exclusion Criteria

Severe psychiatric disorders requiring a higher level of care (e.g., imminent suicidal ideation requiring hospitalization, psychotic features)
Non-English proficiency
I have a physical disability that prevents me from completing study tasks.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Racial SocializationExperimental Treatment2 Interventions
TF-CBT will be implemented enhanced with racial socialization components
Group II: Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Active Control1 Intervention
TF-CBT will be administered as typically implemented at Pediatric Behavioral Health and Wellness outpatient clinic

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
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 (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.
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]

References

Examination of Racial Differences in a Posttraumatic Stress Disorder Group Therapy Program for Veterans. [2019]
Impact of race on early treatment termination and outcomes in posttraumatic stress disorder treatment. [2022]
Racial/ethnic match and treatment outcomes for women with PTSD and substance use disorders receiving community-based treatment. [2023]
Advancing health equity by understanding race disparities and other factors associated with PTSD symptom improvement following evidence-based psychotherapy. [2023]
Therapeutic response to Cognitive Processing Therapy in White and Black female veterans with military sexual trauma-related PTSD. [2022]
Factors Associated with Engaging in Evidence-Based Psychotherapy During the First Year of Posttraumatic Stress Disorder Treatment Between 2017 and 2019. [2023]
Factors associated with completing evidence-based psychotherapy for PTSD among veterans in a national healthcare system. [2020]
Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]
Asylum-seekers' experiences of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder: a qualitative study. [2018]
Trauma-focused cognitive behavioral therapy for children and youth in low and middle-income countries: A systematic review. [2022]
Reappraisal-related neural predictors of treatment response to cognitive behavior therapy for post-traumatic stress disorder. [2022]
Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]
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