Optimizing therapy components for pediatric PTSD with a multiphase design
Official title: Optimizing Behavioral Health Services Following Pediatric Trauma Exposure
Run by University of Rochester · NCT06956781 · Data updated 2026-11-12
This project will try different therapy pieces to see which combinations help children and teens (ages 8–17) with PTSD feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | March 15, 2026 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT06956781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 8–17 with PTSD from at least one DSM-defined trauma, a stable caregiving environment, caregiver permission and involvement, ability to read English, and willingness to be randomized are ideal candidates.
✕Probably not a fit
Children with psychiatric conditions requiring a higher level of care (for example active suicidal intent or a current psychotic disorder), significant cognitive impairment, or those unwilling/unable to be randomized or involve a caregiver are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use a multiphase optimization strategy (MOST) to test how specific treatment components—emotion regulation, exposure, cognitive processing, and bi-lateral stimulation—perform alone and in combination against a psychological placebo. Participants who meet DSM-based PTSD criteria will be randomized to different component combinations and attend weekly treatment sessions while researchers collect symptom and process measures. The design compares each active component to a placebo control to estimate direct effects and examines mechanisms by which components produce change. Caregivers must participate to provide permission and support during the treatment period.
Why it matters
Potential benefit: If successful, the approach could identify the most effective component combinations to make PTSD treatment for children faster, more targeted, and more effective.
How similar studies have gone: Core elements like exposure and cognitive processing have strong evidence in pediatric PTSD, while using a MOST framework to optimize combinations of components is a more novel application in this population.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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The Mt. Hope Family Center
Rochester, New York, United States Recruiting
Study contacts
- Principal investigator: Chad E Shenk, PhD — University of Rochester
- Study coordinator: Chad E Shenk, PhD
- Email: chad.shenk@rochester.edu
- Phone: (585) 275-8704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.