NCT06956781 Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
| NCT ID | NCT06956781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-15 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-03-15 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. 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)
Contact & Investigator
Chad E Shenk, PhD
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT06956781 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06956781 currently recruiting?
Yes, NCT06956781 is actively recruiting participants. Contact the research team at chad.shenk@rochester.edu for enrollment information.
Where is the NCT06956781 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06956781 clinical trial?
NCT06956781 is sponsored by University of Rochester. The principal investigator is Chad E Shenk, PhD at University of Rochester. The trial plans to enroll 200 participants.
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