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Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

NCT ID: NCT06956781Sponsor: University of RochesterLast updated: 2026-04-08

Summary

The goal of this clinical trial is to test the extent to which different treatment components work to improve pediatric post-traumatic stress disorder (PTSD). It will also provide evidence for how these components work. The main research questions are: What are the effects of different components used to treat PTSD? What do these components change to produce benefits in PTSD? Researchers will: Compare components to a psychological placebo to estimate their effects and measure how they work Examine how components work alone and in conjunction with other components Participants will: Receive different combinations of components and placebo Attend weekly treatment sessions Provide information to evaluate changes in PTSD

Arms & interventions

  • BehavioralEmotion Regulation

    Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma

  • BehavioralExposure

    Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals

  • BehavioralCognitive Processing

    Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure

  • BehavioralBi-lateral Stimulation

    Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state

  • BehavioralPsychological Placebo

    Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure

Outcome measures

Primary

  • Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA)

    The CAPS-CA is a clinician-administered diagnostic interview measuring the severity of PTSD symptoms in the past month. The interview assesses 20 PTSD symptoms according to DSM-5 diagnostic criteria with each symptom rated on a severity scale ranging from 0 to 4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS)

    The CPSS is a child-report survey measuring the severity of PTSD symptoms in the past month. Survey items assess 20 PTSD symptoms according to DSM-5 diagnostic criteria with severity ratings for each item ranging from 0-4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2)

    The CATS-2 is a caregiver-reported survey measuring the frequency of pediatric PTSD symptoms in the past four weeks. Survey items assess 20 PTSD symptoms according to DSM-5 and ICD-11 diagnostic criteria with frequency ratings for each item ranging from 0-3. Ratings for each individual item are summed with higher scores indicating greater frequencies of PTSD symptoms (total scores range from 0-60).

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

Secondary

  • Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS)

    Time frame: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)

  • Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2)

    Time frame: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)

  • Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED)

    Time frame: Baseline (pre-treatment, Week 19 (post-treatment)

  • Mean Change in Disruptive Behavior Disorder Symptoms - Child Behavior Checklist (CBCL)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Change in PTSD, Mood, Anxiety, and Disruptive Behavior Disorder Symptom Trajectories - Ecological Momentary Assessment (EMA)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Changes in Trajectories of C-Reactive Protein (CRP)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Changes in Trajectories of Interleukin-6 (IL-6)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Changes in Trajectories of Tumor Necrosis Factor-Alpha

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Brain Aging - Magnetic Resonance Imaging (MRI)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Change in Neural Structure - Magnetic Resonance Imaging (MRI)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Change in Network Connectivity - Magnetic Resonance Imaging (MRI)

    Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)

  • Mean Change in Experiential Avoidance - Avoidance and Fusion Questionnaire for Youth (AFQ-Y)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change in Trauma-Related Cognitions - Child Post-Traumatic Cognitions Inventory (CPTCI)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change in Emotion Transitions - Affect Transition Task

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change Subclinical Psychosis - Prodromal Questionnaire Brief Child Version Screener (PQ-BC)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change Transdiagnostic Psychiatric Symptoms - The Kiddie Schedule for Affective Disorders and Schizophrenia - Cross Cutting Symptoms (K-SADS-CC)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

  • Mean Change Transdiagnostic Psychiatric Symptoms - The Kiddie Schedule for Affective Disorders and Schizophrenia - Cross Cutting Symptoms (K-SADS-CC)

    Time frame: Baseline (pre-treatment), Week 19 (post-treatment)

Eligibility criteria

Sex: AllAge: 8 Years to 17 YearsHealthy volunteers: No
Inclusion Criteria: A child between the ages of 8-17 exposed to at least one DSM-defined trauma Child assent for participation The participation of a caregiver with custodial rights to provide parental permission Willing to participate in treatment delivery and respond to surveys Meet PTSD diagnostic criteria that is the result of exposure to at least one of the identified traumas Ability to read and understand English Willingness to be randomized to an experimental condition Placement in a stable caregiving environment for two months without an impending transition Children currently taking psychotropic medications must have taken the medicine without dose adjustment for two months prior to study entry. Caregiver or child with a smartphone capable of downloading a freely available software application. Exclusion Criteria: Psychiatric concerns requiring a higher level of care (e.g. suicidal ideation with intent; current psychotic disorder) An intelligence quotient (IQ) \< 70 Currently receiving a behavioral health intervention for concerns related to PTSD or pediatric trauma A participating caregiver who is a perpetrator of any identified trauma (e.g. sexual abuse) MRI contraindicators (e.g. presence of metal in the body)

Study locations (1)

The Mt. Hope Family Center

Rochester, New York, 14608

Recruiting
Haley Trehern, BS · Contact
585-481-7609haley_trehern@urmc.rochester.edu
Chad Shenk, PhD · Contact
585-273-3264chad.shenk@rochester.edu
Chad Shenk, PhD · Principal Investigator