Resilient Roots: Supporting Youth and Families (IDEA)

TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention Project 3

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)

Detailed Description

Child abuse and neglect (CAN) represents a pathogenic relational environment that confers significant risk for maladaptation. The deleterious sequelae accompanying child abuse and neglect result in adverse physical and mental health consequences during childhood and initiate a negative developmental cascade that continues throughout the life course. The proximal environment involving the nuclear family, as well as more distal factors associated with the community and context, transact to undermine normal biological and psychological developmental processes in these vulnerable children. For youth from high-risk communities, these negative sequelae are compounded by the effects of additional socioecological stress that may further undermine their wellbeing and adaptive functioning. Some youth are disproportionately represented within Child Protective Services (CPS) and child welfare systems and yet less likely to receive mental health services, particularly high-quality evidence-based treatments. Within families, socioecological stress may impact developmental trajectories from pregnancy through adulthood. Caregivers' wellbeing and stress levels, parenting practices, and competence in promoting positive identity may influence youths' development of accurate appraisal strategies and positive coping skills to protect them from stress. Families with effective communication strategies to discuss community strengths, navigate through stressful encounters, and build self-esteem may be more likely to buffer the effects of stress on their children's development. Although evidence-based trauma treatments to address the effects of child abuse and neglect, such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), have demonstrated efficacy in reducing symptoms of posttraumatic stress (PTSD) broadly speaking, they are not designed to address the specific challenges that youth from socioecological contexts with multiple risk factors along with child abuse and neglect experiences face in counteracting both PTSD and additional stress. Novel approaches are being developed that can support families in building socialization skills. This pilot study examines the feasibility and acceptability of augmenting TF-CBT with socialization practices to improve outcomes for youth ages 10-15 who have experienced child abuse and neglect and their families by supporting parenting strategies. A RE-AIM/PRISM framework (including Reach, Effectiveness, Adoption, Implementation, and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting) is incorporating stakeholder perspectives and evaluating the enhanced version of TF-CBT compared with current practices, while identifying barriers and facilitators to implementation to guide future larger-scale trials. Developing interventions to support parenting strategies that can promote positive socialization and identity for youth facing the combined effects of child abuse and neglect and socioecological stress is of high public health significance. Given the lifelong cascades that accompany child abuse and neglect and discrimination, determining best practices for improving behavioral health outcomes for youth who have experienced child abuse and neglect is highly significant.

This Resilient Roots Pilot is integrated into the TRANSFORM Center on Child Abuse and Neglect to promote translation of research findings into clinical interventions, to inform the next generation of research on child abuse and neglect, and to facilitate dissemination of research and practice knowledge/skills to varied stakeholders. The research utilizes a developmental psychopathology perspective, incorporating multiple methods within a lifespan framework and implementation science approach. Exposure to child abuse and neglect frequently results in long-term detrimental effects on mental health. 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 TF-CBT is an evidence-based treatment for children who have experienced trauma, determining best practices for implementing enhanced TF-CBT with socialization components is urgently needed to address these gaps and provide optimal intervention.

The study Aims for the full project are as follows:

Aim 1: From a community-based participatory research framework, engage community partners and assess acceptability of augmenting TF-CBT for youth ages 10-15, as well as to inform study design, and implementation via focus groups with diverse stakeholders (youth, family, mental health clinicians) to inform Aim 2.

Aim 2: Evaluate the feasibility of a pilot randomized control trial testing the augmentation of TF-CBT to improve coping and socialization, and to reduce mental health symptoms in youth with CAN histories.

Aim 3: Investigate whether TF-CBT leads to greater improvement in mental health symptoms for youth with CAN when augmented with addressing socioecological stresses.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jody T Manly, Ph.D.; Phone Number: 251 5852752991; Email: Jody_Manly@urmc.rochester.edu
• Study Contact Backup: Name: Sheree L Toth, Ph.D.; Phone Number: 5852752991; Email: sheree_toth@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14608
      • Recruiting
      • Mt. Hope Family Center
      • Contact: Sheree Toth, PhD; Phone Number: 585-275-2991; Email: sheree_toth@urmc.rochester.edu
      • Contact: Jody T Manly, Ph.D.; Phone Number: 251 (585) 275-2991; Email: jody_manly@urmc.rochester.edu
      • Principal Investigator: Sheree Toth, PhD
      • Sub-Investigator: Jody T Todd Manly, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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.
Experimental: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization; TF-CBT will be implemented enhanced with socialization components	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant attendance and participation in treatment	Number of sessions completed	Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Patient Perceptions of Treatment	Participant satisfaction with intervention assessed through a Client Satisfaction Questionnaire, 4 point scale that will be scored with reverse scoring on some items such that higher scores are reflective of higher satisfaction, range 9-36	Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Provider Perceptions of Treatment	Clinician satisfaction with intervention assessed through Clinician Evaluation Questionnaire, with 7-point scale with higher scores indicating more agreement across domains of knowledge, confidence, intentions, consequences, resources, social influences, priorities, intervention characteristics, and memory	Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2P50HD096698 (U.S. NIH Grant/Contract); 2P50HD096698-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will share de-identified data using NICHD Data Specimen Hub (DASH).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No