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

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

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

Sponsors & Collaborators

• University of Rochester

  lead OTHER

Principal Investigators

• Chad E Shenk, PhD · University of Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2028-08-31

Completion

2028-08-31

Countries

• United States

Study Locations