Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
Launched by UNIVERSITY OF ROCHESTER · Apr 24, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to find out how effective different treatments are for children aged 8 to 17 who have been diagnosed with post-traumatic stress disorder (PTSD) after experiencing trauma. Researchers want to learn which parts of the treatments work best and how they help improve PTSD symptoms. Participants will receive various combinations of treatment options and a placebo, which is a fake treatment that does not contain any active ingredients. They will attend weekly sessions and share their experiences to help the researchers understand the changes in their PTSD symptoms.
To be eligible for the trial, children must have experienced at least one traumatic event and meet certain criteria for PTSD. They need consent from a parent or guardian and must be willing to participate in the treatment and answer surveys. Children currently facing severe mental health issues or receiving other treatments for PTSD may not qualify. The study is not yet recruiting participants, but it aims to provide valuable insights into how to better support young people dealing with the effects of trauma.
Gender
ALL
Eligibility criteria
- 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.
- 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)
About University Of Rochester
The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Chad E Shenk, PhD
Principal Investigator
University of Rochester
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported