Optimizing therapy components for pediatric PTSD with a multiphase design

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

This project will try different therapy pieces to see which combinations help children and teens (ages 8–17) with PTSD feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: University of Rochester (other)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT06956781 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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)

Where this trial is running

Rochester, New York

• 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

Conditions: PTSD, Trauma, Pediatric ALL, Pediatric, Multiphase Optimization Strategy