Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD) (MOST for PTSD)
Status
Conditions
Treatments
Details and patient eligibility
About
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
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
125 participants in 16 patient groups
Trial contacts and locations
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Central trial contact
Chad E Shenk, PhD
Data sourced from clinicaltrials.gov
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