Clinical trial NCT06535516: Resilient Roots: Supporting Youth and Families
Official title: TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention Project 3
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trauma-Focused Cognitive Behavioral Therapy and Racial Socialization
Primary purpose: TREATMENT

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 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. 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 racial socialization into TF-CBT, while identifying barriers and facilitators to implementation to guide future larger-scale trials.

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 culture, transact to undermine normal biological and psychological developmental processes in these vulnerable children. For Black youth, these negative sequelae are compounded by the effects of racial stress that further undermine their wellbeing and adaptive functioning. Black 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, racial stress may impact developmental trajectories from pregnancy through adulthood. Caregivers' wellbeing and stress levels, parenting practices, and competence in promoting positive racial identity may influence youths' development of accurate appraisal strategies and positive coping skills to protect them from racial stress. Families with effective communication strategies to discuss cultural strengths, navigate through racially stressful encounters, and build self-esteem may be more likely to buffer the effects of racial 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 Black youth with child abuse and neglect experiences face in counteracting both PTSD and racial stress. Mental health clinicians are often unprepared to address the impact of experiences of racism and may underestimate the impact of racial stress. Novel approaches are being developed that can support families in building racial socialization skills. One such approach has been designed to incorporate racial socialization into a standard course of TF-CBT. This pilot study will examine the feasibility and acceptability of incorporating racial socialization practices with TF-CBT to enhance outcomes for Black youth ages 10-15 who have experienced child abuse and neglect. A RE-AIM/PRISM framework (including Reach, Effectiveness, Adoption, Implementation, and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting) will incorporate stakeholder perspectives and evaluate TF-CBT with integrated racial socialization to ascertain whether this approach is acceptable based on stakeholder input. Additionally, identification of barriers and facilitators to implementation to guide future larger-scale trials will be addressed. Developing interventions to support parenting strategies that can promote positive racial socialization and racial identity for Black youth facing the combined effects of child abuse and neglect and racial stress is of high public health significance. Given the lifelong cascades that accompany child abuse and neglect and racial discrimination, determining best practices for improving behavioral health outcomes for Black 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. Disproportionate representation of Black youth in the Child Protective Services (CPS) and child welfare system is associated with health disparities. For youth who have experienced racial and ethnic marginalization, the trauma associated with child abuse and neglect 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 TF-CBT is an evidence-based treatment for children who have experienced trauma, 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.

The study Aims for the full project are as follows:

Aim 1: From a community-based participatory research framework (CBPR), engage community partners and assess acceptability of racial socialization (RS) procedures to augment TF-CBT for Black youth ages 10-15, as well as to inform study design, and implementation plans through 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 (RCT) testing the incorporation of racial socialization into standard TF-CBT to improve coping, racial socialization, and to reduce mental health symptoms in Black youth with child abuse and neglect histories.

Aim 3: Investigate whether TF-CBT leads to greater improvement in mental health symptoms for Black youth with child abuse and neglect when augmented with incorporated racial socialization principles into TF-CBT.

Eligibility criteria: Inclusion Criteria:

Participants will be:

* Youth who are seeking services at the University of Rochester Medical Center Pediatric Behavioral Health and Wellness
* Youth ages 10-15 years at the time of enrollment who self-identify as Black.
* 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

Primary outcomes:
measure: Change in Posttraumatic Stress Symptoms
timeFrame: Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later
Secondary outcomes:
measure: Patient Perceptions of Treatment
timeFrame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
measure: Provider Perceptions of Treatment
timeFrame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
measure: Participant attendance and participation in treatment
timeFrame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
References: