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Posttraumatic Stress DisorderNCT06535516

Resilient Roots: Supporting Youth and Families

A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S) in people with Posttraumatic Stress Disorder, run by University of Rochester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
15 Jul 2024to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Mt. Hope Family Center

    Rochester, New York, 14608

    Sheree Toth, PhD, 585-275-2991, sheree_toth@urmc.rochester.edu

    Jody T Manly, Ph.D., (585) 275-2991 ext. 251, jody_manly@urmc.rochester.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Behavioural

    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)Behavioural

    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.

Study groups in NCT06535516
Study groupRoleWhat they receive
Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)Active comparatorTF-CBT will be administered as typically implemented at Pediatric Behavioral Health and Wellness outpatient clinic
Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and SocializationExperimentalTF-CBT will be implemented enhanced with socialization components
Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT); Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)
  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

    Measured: 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

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

  3. Participant attendance and participation in treatment

    Number of sessions completed

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start15 Jul 2024
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Trauma-Focused Cognitive Behavioral Therapy and Socialization
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06535516
Sponsor's protocol ID
2P50HD096698
Other IDs
2P50HD096698-06
Status last verified
Aug 2026
First submitted
17 Jul 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study will share de-identified data using NICHD Data Specimen Hub (DASH).

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S) in people with Posttraumatic Stress Disorder, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jody T Manly, Ph.D. (5852752991 ext. 251, Jody_Manly@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Posttraumatic Stress Symptoms (time frame: Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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