Recruiting

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

Sponsor:

University of Rochester

Code:

NCT06956781

Conditions

PTSD

Trauma

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Emotion Regulation

Exposure

Cognitive Processing

Bi-lateral Stimulation

Psychological Placebo

Study Details

Brief 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

Study ID

NCT06956781

Start date

Mar 15, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Emotion Regulation

Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma

Exposure

Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals

Cognitive Processing

Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure

Bi-lateral Stimulation

Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state

Psychological Placebo

Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure

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) ]
Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS) [ Time Frame: Baseline (pre-treatment), Week 19 (post-treatment) ]
Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2) [ Time Frame: Baseline (pre-treatment), Week 19 (post-treatment) ]

Central Contacts and Locations

Central contacts

Chad E Shenk, PhD

(585) 275-8704 chad.shenk@rochester.edu

Locations

The Mt. Hope Family Center

Recruiting

Rochester, New York, United States, 14608

Contacts

Haley Trehern, BS

585-481-7609 haley_trehern@urmc.rochester.edu

Chad Shenk, PhD

585-273-3264 chad.shenk@rochester.edu

Principal Investigator:

Chad Shenk, PhD

More Information

Sponsor

University of Rochester

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

PTSD
Trauma
Pediatric
Multiphase Optimization Strategy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-04-08.