Clinical trial for PTSD
Official title Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
ClinicalTrials.gov ID: NCT06956781
What this study is testing
- What it's testing
- The study aims to find out which treatment components improve pediatric PTSD and how they produce those changes.
- Who it's for
- Children who have been diagnosed with post‑traumatic stress disorder.
- What's involved
- Kids will attend weekly sessions where they receive different combinations of therapy components and a psychological placebo, and they will provide information about their PTSD symptoms.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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 assigned by chance 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.
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Rochester, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.