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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06956781
Status
Recruiting
Apply to this trial

Conditions

  • PTSD
  • Pediatric ALL
  • Trauma

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 15, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Condition 1
    Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
  • Experimental: Treatment Condition 2
    Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo
  • Experimental: Treatment Condition 3
    Participants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 4
    Participants receive emotion regulation, exposure, and psychological placebo
  • Experimental: Treatment Condition 5
    Participants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 6
    Participants receive emotion regulation, cognitive processing, and psychological placebo
  • Experimental: Treatment Condition 7
    Participants receive emotion regulation, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 8
    Participants receive emotion regulation and psychological placebo
  • Experimental: Treatment Condition 9
    Participants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 10
    Participants receive exposure, cognitive processing, and psychological placebo
  • Experimental: Treatment Condition 11
    Participants receive exposure, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 12
    Participants receive exposure and psychological placebo
  • Experimental: Treatment Condition 13
    Participants receive cognitive processing, bi-lateral stimulation, and psychological placebo
  • Experimental: Treatment Condition 14
    Participants receive cognitive processing and psychological placebo
  • Experimental: Treatment Condition 15
    Participants receive bi-lateral stimulation and psychological placebo
  • Experimental: Treatment Condition 16
    Participants receive psychological placebo

Primary Outcome Measure

Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA) [ Time Frame: Baseline (pre-treatment), Week 19 (post-treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Mt. Hope Family CenterRochesterNew York14608
Haley Trehern, BS
[email protected]
585-481-7609
Chad Shenk, PhD
[email protected]
585-273-3264
Chad Shenk, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, NY

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
The Mt. Hope Family Center· Rochester, NY

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