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

Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests which parts of treatment help children ages 8–17 with PTSD, a mental health condition after a traumatic event. It looks at how these parts work alone and together, compared with a placebo treatment used for comparison. Children will attend weekly sessions and share information about changes in their PTSD.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 8–17 and have PTSD caused by at least one traumatic event that meets the study’s rules.
  • The child must agree to join, and a caregiver with legal custody must take part and give permission.
  • Be willing to take part in treatment and answer surveys.
  • Be able to read and understand English.
  • Be willing to have the treatment group chosen by chance.
  • Have a stable caregiving home for two months, with no upcoming change planned.
  • If taking medicine for mental health, have no dose changes for two months before joining.
  • The child or caregiver must have a smartphone that can download a free app.

Who can't join

  • Have mental health needs that require more intensive care, such as intent to act on suicidal thoughts or a current disorder that affects what seems real.
  • Have an IQ score below 70, a measure of thinking and learning skills.
  • Already receive behavioral or mental health treatment for PTSD or childhood trauma.
  • The caregiver taking part caused any of the identified traumas, such as sexual abuse.
  • Have a reason an MRI scan would not be safe, such as metal in the body.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

NY