RecruitingNot ApplicableNCT06956781

Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure


Sponsor

University of Rochester

Enrollment

200 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Inclusion Criteria10

  • 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 Criteria5

  • 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)

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


Locations(1)

The Mt. Hope Family Center

Rochester, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06956781


Related Trials