Infusing Diversity to Enhance Adapted Treatment (IDEA)
NCT Number: NCT06535516
Acronym: IDEA
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Posttraumatic Stress Disorder
Interventions: BEHAVIORAL: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)|BEHAVIORAL: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Racial Socialization (RS)
Sponsor: University of Rochester
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2028-08
Locations: Mt. Hope Family Center, Rochester, New York, 14608, United States

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.

Primary Outcome Measures: Change in Posttraumatic Stress Symptoms, Change in symptoms of posttraumatic stress as measured by the UCLA PTSD Reaction Index. Lower scores indicate lower symptoms of posttraumatic stress (range 0-80)., Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later
Secondary Outcome Measures: Perceptions of Treatment, Participant satisfaction with intervention assessed through Participant Evaluation Questionnaire, Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment|Perceptions of Treatment, Clinician satisfaction with intervention assessed through Clinician Evaluation Questionnaire, Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment|Participant attendance and participation in treatment, Number of sessions completed, Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment