Recruiting

Enhanced TF-CBT

Sponsor:

University of Rochester

Code:

NCT06535516

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Accepted

Interventions

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

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

Study Details

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

Study ID

NCT06535516

Start date

Jul 15, 2024

Status verified date

Aug, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 15

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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 Socialization

TF-CBT will be implemented enhanced with socialization components

Interventions

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

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.

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

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.

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 and Locations

Central contacts

Locations

Mt. Hope Family Center

Recruiting

Rochester, New York, United States, 14608

Contacts

Principal Investigator:

Sheree Toth, PhD

More Information

Sponsor

University of Rochester

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-09-03.