Resilient Roots: Supporting Youth and Families

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-15
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Active comparator 1 intervention
Group B: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and SocializationExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later

Secondary outcomes

1

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

Time frame
Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
2

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

Time frame
Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
3

Participant attendance and participation in treatment

Number of sessions completed

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator