← Back to Search

Behavioral Intervention

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Racial Socialization for Post-Traumatic Stress Disorder (IDEA Trial)

N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Youth ages 10-14 years who self-identify as Black.
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Awards & highlights

Summary

IDEA 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. IDEA 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves psychological therapy, side effects might include emotional discomfort or distress when discussing traumatic experiences. However, these therapies are generally considered safe and aim to reduce PTSD symptoms over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Posttraumatic Stress Symptoms
Secondary study objectives
Participant attendance and participation in treatment
Perceptions of Treatment

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
2012
N/A
~160

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
853 Previous Clinical Trials
538,854 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,001 Previous Clinical Trials
2,688,154 Total Patients Enrolled
~40 spots leftby Aug 2027