Clinical trial NCT06956781: Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
Official title: Optimizing Behavioral Health Services Following Pediatric Trauma Exposure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD
Trauma
Pediatric ALL
Keywords: PTSD
Trauma
Pediatric
Multiphase Optimization Strategy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 125
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2\^4 Full Factorial Randomized Clinical Trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

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)

Primary outcomes:
measure: Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
Secondary outcomes:
measure: Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS)
timeFrame: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)
measure: Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2)
timeFrame: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)
measure: Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: Baseline (pre-treatment, Week 19 (post-treatment)
measure: Mean Change in Disruptive Behavior Disorder Symptoms - Child Behavior Checklist (CBCL)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Change in PTSD, Mood, Anxiety, and Disruptive Behavior Disorder Symptom Trajectories - Ecological Momentary Assessment (EMA)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Changes in Trajectories of C-Reactive Protein (CRP)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Changes in Trajectories of Interleukin-6 (IL-6)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Changes in Trajectories of Tumor Necrosis Factor-Alpha
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Brain Aging - Magnetic Resonance Imaging (MRI)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Change in Neural Structure - Magnetic Resonance Imaging (MRI)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Change in Network Connectivity - Magnetic Resonance Imaging (MRI)
timeFrame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)
measure: Mean Change in Experiential Avoidance - Avoidance and Fusion Questionnaire for Youth (AFQ-Y)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change in Trauma-Related Cognitions - Child Post-Traumatic Cognitions Inventory (CPTCI)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change in Emotion Transitions - Affect Transition Task
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
measure: Mean Change Subclinical Psychosis - Prodromal Questionnaire Brief Child Version Screener (PQ-BC)
timeFrame: Baseline (pre-treatment), Week 19 (post-treatment)
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Chad E Shenk, PhD
role: PRINCIPAL_INVESTIGATOR
References: