Resilient Roots: Supporting Youth and Families
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT06535516
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 15 Years
- Healthy Volunteers
- Accepted
Interventions
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) — BEHAVIORALTF-CBT is a well-established trauma treatment for children ages 3-17 years that demonstrates improved outcomes relative to other active treatments. Originally developed for treatment of childhood sexual abuse, evidence from numerous randomized clinical trials (RCT) demonstrates that TF-CBT is one of the most effective treatments for children with PTSD and/or depression resulting from many forms of child abuse and neglect as well as other traumatic experiences.TF-CBT is rated by California Evidence-Based Clearinghouse for Child Welfare as highly relevant for child welfare and well-supported in improving children's outcomes, including reduced PTSD symptoms, behavior problems, depression, and shame, and improving parental support related to their children's experiences.
- Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S) — BEHAVIORALThe study will compare standard TF-CBT with TF-CBT augmented with Socialization enhancements. TF-CBT+S includes enhancements to address socioecological stress and trauma and provide coping strategies to support positive socialization.
Study Details
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 socioecological stress, the trauma associated with CAN may be compounded by stress and trauma deriving from experiences of stress in their communities. Interventions to address specific socioecological stress for symptomatic youth receiving human centered mental health services are lacking, and use of mental health services that are acceptable to 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 socialization and coping skills specific to addressing contextual stress and trauma has relevance for 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 socialization components is urgently needed to address these gaps and provide optimal intervention. 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 socialization into enhanced TF-CBT, while identifying barriers and facilitators to implementation to guide future larger-scale trials.
Key Dates
- Start date
- Jul 15, 2024
- Status verified
- Jul 2025
- Primary completion
- Aug 1, 2027
- Completion
- Aug 1, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)TF-CBT will be administered as typically implemented at Pediatric Behavioral Health and Wellness outpatient clinic
- Experimental: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and SocializationTF-CBT will be implemented enhanced with socialization components
Primary Outcome Measure
Change in Posttraumatic Stress Symptoms [ Time Frame: Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later ]
Central Contacts
- Jody T Manly, Ph.D.5852752991
- Sheree L Toth, Ph.D.5852752991
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mt. Hope Family Center | Rochester | New York | 14608 | Sheree Toth, PhD (PRINCIPAL_INVESTIGATOR) Jody T Todd Manly, PhD (SUB_INVESTIGATOR) |
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