NCT06956781

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

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• PTSD
• Trauma
• Pediatric ALL

Interventions

Type	Name	Description
BEHAVIORAL	Emotion Regulation	Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
BEHAVIORAL	Exposure	Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
BEHAVIORAL	Cognitive Processing	Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
BEHAVIORAL	Bi-lateral Stimulation	Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
BEHAVIORAL	Psychological Placebo	Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-05-04
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States