Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
NCT ID: NCT06956781
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2026-01-31
2028-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Treatment Condition 10
Participants receive exposure, cognitive processing, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Treatment Condition 11
Participants receive exposure, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Exposure
Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
Bi-lateral Stimulation
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Treatment Condition 12
Participants receive exposure and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Exposure
Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
Treatment Condition 13
Participants receive cognitive processing, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Treatment Condition 14
Participants receive cognitive processing and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Cognitive Processing
Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
Treatment Condition 15
Participants receive bi-lateral stimulation and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Bi-lateral Stimulation
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Treatment Condition 16
Participants receive psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Treatment Condition 1
Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
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
Treatment Condition 2
Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Treatment Condition 3
Participants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Bi-lateral Stimulation
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Treatment Condition 4
Participants receive emotion regulation, exposure, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Treatment Condition 5
Participants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Emotion Regulation
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
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
Treatment Condition 6
Participants receive emotion regulation, cognitive processing, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Emotion Regulation
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
Cognitive Processing
Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
Treatment Condition 7
Participants receive emotion regulation, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Emotion Regulation
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
Bi-lateral Stimulation
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Treatment Condition 8
Participants receive emotion regulation and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Emotion Regulation
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
Treatment Condition 9
Participants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo
Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Interventions
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Psychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
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
Eligibility Criteria
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Inclusion Criteria
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
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)
8 Years
17 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Responsible Party
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Chad Shenk
Professor of Psychology
Principal Investigators
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Chad E Shenk, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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The Mt. Hope Family Center
Rochester, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00010448
Identifier Type: -
Identifier Source: org_study_id
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