Clinical trial · Interventional
Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
Optimizing Behavioral Health Services Following Pediatric Trauma Exposure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| PTSD | — | UNRESOLVED | — |
| Trauma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi-lateral Stimulation | Behavioral | — | UNRESOLVED |
| Cognitive Processing | Behavioral | — | UNRESOLVED |
| Emotion Regulation | Behavioral | — | UNRESOLVED |
| Exposure | Behavioral | — | UNRESOLVED |
| Psychological Placebo | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- Treatment Condition 1
- description
- Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
- interventionNames
- Behavioral: Emotion Regulation
- Behavioral: Exposure
- Behavioral: Cognitive Processing
- Behavioral: Bi-lateral Stimulation
- type
- EXPERIMENTAL
- label
- Treatment Condition 2
- description
- Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo
- interventionNames
- Behavioral: Emotion Regulation
- Behavioral: Exposure
- Behavioral: Cognitive Processing
- Behavioral: Psychological Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available