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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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.
- Conditions
- Posttraumatic Stress Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) | Active comparator | TF-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 Socialization | Experimental | TF-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.
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)
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
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
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.
- First posted2 Aug 2024
- Study start15 Jul 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sheree Toth, University of Rochester
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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSFORM: Translational Research That Adapts New Science FOR Maltreatment Prevention Project 3
- ClinicalTrials.gov ID
- NCT06535516
- Acronym / sponsor ID
- 2P50HD096698
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Trauma-Focused Cognitive Behavioral Therapy and Socialization
| Arm | Type | Receives |
|---|---|---|
| Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) | Active comparator | Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)TF-CBT will be administered as typically implemented at Pediatric Behavioral Health and Wellness outpatient clinic |
| Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) augmented with Socialization (S)TF-CBT will be implemented enhanced with socialization components |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization |
| 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. | Behavioural | Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Socialization |
Primary outcome
Change in Posttraumatic Stress Symptoms
Time frame: Assessed at pre- and post-intervention (following 12-25 sessions), approximately 6 months later
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).
3 secondary outcomes
Patient Perceptions of Treatment
Time frame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Provider Perceptions of Treatment
Time frame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Participant attendance and participation in treatment
Time frame: Assessed at intervention completion (following 12-25 sessions), approximately 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. The study will share de-identified data using NICHD Data Specimen Hub (DASH).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.