Resilient Roots: Supporting Youth and Families

NCT06535516 | Recruiting DMC

• 2 other identifiers: 2P50HD0966982P50HD096698-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Posttraumatic Stress Symptoms

  Change in symptoms of posttraumatic stress as measured by Child Posttraumatic Stress Disorder Symptom Checklist (Child Report). 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 Outcomes (3)

• Patient Perceptions of Treatment

  Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment

• Provider Perceptions of Treatment

  Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment

• Participant attendance and participation in treatment

  Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment

Study Arms (2)

Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

ACTIVE COMPARATOR

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

Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization

EXPERIMENTAL

TF-CBT will be implemented enhanced with socialization components

Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)

Interventions

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) BEHAVIORAL

TF-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.

Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S) BEHAVIORAL

The 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.

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Youth participants will be:
• Youth who are seeking services at the University of Rochester Medical Center Pediatric Behavioral Health and Wellness and whose caregivers consent to participate and youth assent to participate.
• Youth ages 10-15 years at the time of enrollment.
• 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 trauma exposure during the phone screen at intake or on the Child PTSD Symptom Checklist assessment tool completed independently by youth.

You may not qualify if:

• Significant cognitive limitations or psychiatric condition that would interfere with ability to participate in the assessment and treatment portions of the study
• Physical disability, if we do not have a way of providing necessary accommodations to allow them to engage in the study
• Youth in foster care or residential treatment
• Caregivers with self-reported significant psychiatric needs or substance use requiring inpatient treatment that would interfere with their ability to participate in the assessment and treatment of study
• Language: English speaking proficiency that precludes completing assessment measures

Sponsors & Collaborators

• University of Rochester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Mt. Hope Family Center

Rochester, New York, 14608, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Jody T Manly, Ph.D.

CONTACT

5852752991; Jody_Manly@urmc.rochester.edu

Sheree L Toth, Ph.D.

CONTACT

5852752991; sheree_toth@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistants will be blind to which arm the participant has been randomly assigned to and to study hypotheses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Trauma-Focused Cognitive Behavioral Therapy and Socialization

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 2, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)