Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
MOST for PTSD
Optimizing Behavioral Health Services Following Pediatric Trauma Exposure
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
April 8, 2026
April 1, 2026
2.4 years
April 24, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA)
The CAPS-CA is a clinician-administered diagnostic interview measuring the severity of PTSD symptoms in the past month. The interview assesses 20 PTSD symptoms according to DSM-5 diagnostic criteria with each symptom rated on a severity scale ranging from 0 to 4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).
Baseline (pre-treatment), Week 19 (post-treatment)
Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS)
The CPSS is a child-report survey measuring the severity of PTSD symptoms in the past month. Survey items assess 20 PTSD symptoms according to DSM-5 diagnostic criteria with severity ratings for each item ranging from 0-4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).
Baseline (pre-treatment), Week 19 (post-treatment)
Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2)
The CATS-2 is a caregiver-reported survey measuring the frequency of pediatric PTSD symptoms in the past four weeks. Survey items assess 20 PTSD symptoms according to DSM-5 and ICD-11 diagnostic criteria with frequency ratings for each item ranging from 0-3. Ratings for each individual item are summed with higher scores indicating greater frequencies of PTSD symptoms (total scores range from 0-60).
Baseline (pre-treatment), Week 19 (post-treatment)
Secondary Outcomes (19)
Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA)
Baseline (pre-treatment), Week 19 (post-treatment)
Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS)
Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)
Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2)
Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)
Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2)
Baseline (pre-treatment), Week 19 (post-treatment)
Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED)
Baseline (pre-treatment, Week 19 (post-treatment)
- +14 more secondary outcomes
Study Arms (16)
Treatment Condition 1
EXPERIMENTALParticipants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
Treatment Condition 2
EXPERIMENTALParticipants receive emotion regulation, exposure, cognitive processing, and psychological placebo
Treatment Condition 3
EXPERIMENTALParticipants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo
Treatment Condition 4
EXPERIMENTALParticipants receive emotion regulation, exposure, and psychological placebo
Treatment Condition 5
EXPERIMENTALParticipants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo
Treatment Condition 6
EXPERIMENTALParticipants receive emotion regulation, cognitive processing, and psychological placebo
Treatment Condition 7
EXPERIMENTALParticipants receive emotion regulation, bi-lateral stimulation, and psychological placebo
Treatment Condition 8
EXPERIMENTALParticipants receive emotion regulation and psychological placebo
Treatment Condition 9
EXPERIMENTALParticipants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo
Treatment Condition 10
EXPERIMENTALParticipants receive exposure, cognitive processing, and psychological placebo
Treatment Condition 11
EXPERIMENTALParticipants receive exposure, bi-lateral stimulation, and psychological placebo
Treatment Condition 12
EXPERIMENTALParticipants receive exposure and psychological placebo
Treatment Condition 13
EXPERIMENTALParticipants receive cognitive processing, bi-lateral stimulation, and psychological placebo
Treatment Condition 14
EXPERIMENTALParticipants receive cognitive processing and psychological placebo
Treatment Condition 15
EXPERIMENTALParticipants receive bi-lateral stimulation and psychological placebo
Treatment Condition 16
EXPERIMENTALParticipants receive psychological placebo
Interventions
Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Mt. Hope Family Center
Rochester, New York, 14608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad E Shenk, PhD
University of Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Independent and masked raters of treatment fidelity; Independent and masked raters of processes of change during active treatment
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychology
Study Record Dates
First Submitted
April 24, 2025
First Posted
May 4, 2025
Study Start
March 15, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- De-identified data and statistical code will be shared following closure of the trial and after primary hypotheses have been tested and results published
- Access Criteria
- Freely available to scientists via open science outlets
De-identified data and analytic code will be shared on open science outlets