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Recruiting NCT06956781

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

No phase Interventional PTSD Trauma Pediatric ALL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emotion Regulation, Exposure, Cognitive Processing, Bi-lateral Stimulation.
Who it may be relevant to
Registry conditions: PTSD, Trauma, Pediatric ALL. Basic parameters: 8 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

Overview

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

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

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA) [Time frame: Baseline (pre-treatment), Week 19 (post-treatment)]
  • Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS) [Time frame: Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)]
  • Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2) [Time frame: 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) [Time frame: Baseline (pre-treatment), Week 19 (post-treatment)]
  • Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED) [Time frame: Baseline (pre-treatment, Week 19 (post-treatment)]
  • Mean Change in Disruptive Behavior Disorder Symptoms - Child Behavior Checklist (CBCL) [Time frame: Baseline (pre-treatment), Week 19 (post-treatment)]
  • Change in PTSD, Mood, Anxiety, and Disruptive Behavior Disorder Symptom Trajectories - Ecological Momentary Assessment (EMA) [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
  • Changes in Trajectories of C-Reactive Protein (CRP) [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
  • Changes in Trajectories of Interleukin-6 (IL-6) [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
  • Changes in Trajectories of Tumor Necrosis Factor-Alpha [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
  • Brain Aging - Magnetic Resonance Imaging (MRI) [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]
  • Change in Neural Structure - Magnetic Resonance Imaging (MRI) [Time frame: Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment)]

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.

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Mt. Hope Family Center — Rochester

Identifiers

NCT: NCT06956781 · STUDY00010448

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗