Treatment Components for Pediatric Post-Traumatic Stress Disorder
(MOST for PTSD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how well different therapy components help children with post-traumatic stress disorder (PTSD) improve. The study will examine various therapy elements, such as emotion regulation and cognitive processing, and compare them to a placebo treatment to identify the most effective approach. Participants will attend weekly sessions and provide feedback on their PTSD symptoms. Children aged 8-17 who have experienced a traumatic event and meet PTSD criteria may find this trial suitable. The trial employs a Multiphase Optimization Strategy (MOST) to evaluate these therapy components. As an unphased trial, it offers a unique opportunity to contribute to understanding effective PTSD treatments for children.
Will I have to stop taking my current medications?
If your child is currently taking psychotropic medications, they must have been on the same dose for at least two months before joining the study. There is no mention of needing to stop these medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that treatments using the Multiphase Optimization Strategy (MOST) for children with PTSD (post-traumatic stress disorder) are generally safe. Previous studies have found that components of the treatment, such as helping children manage emotions, face fears, understand thoughts, and use techniques like bilateral stimulation, are well-tolerated.
Reports of negative side effects from these treatment components are rare. For instance, cognitive processing therapy, often used to treat PTSD, has been safely adapted for various groups, including veterans, suggesting its safety for broader use.
Although detailed safety data for each treatment component isn't always available, these methods are based on evidence-supported practices. They have been tested and refined to ensure safety for participants. Overall, available data indicates that these treatments are safely managed in controlled settings.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it uses a Multiphase Optimization Strategy (MOST) to explore the best combination of therapeutic techniques for treating pediatric post-traumatic stress disorder (PTSD). Unlike standard treatments like trauma-focused cognitive behavioral therapy (CBT) or medication, this approach investigates various combinations of emotion regulation, exposure, cognitive processing, and bi-lateral stimulation. This method allows for a more tailored treatment plan that could potentially enhance effectiveness and reduce treatment duration, providing a more personalized approach to manage PTSD symptoms in children. By identifying the most effective combinations, researchers aim to optimize treatment outcomes and improve the quality of care for young patients.
What evidence suggests that this trial's treatments could be effective for pediatric PTSD?
This trial will evaluate various treatment components for pediatric post-traumatic stress disorder (PTSD). Research has shown that several types of psychological therapy can effectively treat PTSD in children. Techniques like Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) are strongly recommended for reducing PTSD symptoms. Studies have also found that Eye Movement Desensitization and Reprocessing (EMDR) works well, especially for young people who find it hard to discuss their trauma. In this trial, different treatment arms will explore combinations of emotion regulation, exposure, cognitive processing, and bilateral stimulation. These methods, used alone or together, aim to improve symptoms by helping the brain process traumatic events more effectively.678910
Who Is on the Research Team?
Chad E Shenk, PhD
Principal Investigator
University of Rochester
Are You a Good Fit for This Trial?
This trial is for children aged 8-17 who have experienced trauma and meet the criteria for PTSD. They must understand English, agree to be randomly assigned to a treatment group, and live in a stable environment. A caregiver with custody must give permission. Children on stable psychotropic medication doses for two months can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive different combinations of treatment components and placebo for PTSD, attending weekly treatment sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Multiphase Optimization Strategy (MOST)
Trial Overview
The study tests how different treatments help with pediatric PTSD by comparing them to a psychological placebo. Treatments include Bi-lateral Stimulation, Emotion Regulation, Exposure, Cognitive Processing. Kids will get various combinations of these or placebo during weekly sessions.
How Is the Trial Designed?
16
Treatment groups
Experimental Treatment
Participants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo
Participants receive emotion regulation and psychological placebo
Participants receive emotion regulation, bi-lateral stimulation, and psychological placebo
Participants receive emotion regulation, cognitive processing, and psychological placebo
Participants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo
Participants receive emotion regulation, exposure, and psychological placebo
Participants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo
Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo
Participants receive psychological placebo
Participants receive bi-lateral stimulation and psychological placebo
Participants receive cognitive processing and psychological placebo
Participants receive cognitive processing, bi-lateral stimulation, and psychological placebo
Participants receive exposure and psychological placebo
Participants receive exposure, bi-lateral stimulation, and psychological placebo
Participants receive exposure, cognitive processing, and psychological placebo
Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Citations
Psychological therapies for post‐traumatic stress disorder in ...
Many of the psychological therapies used in treating PTSD include specific techniques, such as psychoeducation to normalise PTSD reactions; ...
Clinical Efficacy of Psychotherapeutic Interventions for Post ...
EMDR has been found to be effective in reducing PTSD symptoms in children and adolescents, and it is advantageous for those who struggle to verbalize their ...
3.
frontiersin.org
frontiersin.org/journals/behavioral-neuroscience/articles/10.3389/fnbeh.2018.00258/fullTreating PTSD: A Review of Evidence-Based ...
Both guidelines strongly recommended use of Prolonged Exposure (PE), Cognitive Processing Therapy (CPT) and trauma-focused Cognitive Behavioral Therapy (CBT).
PTSD Psychotherapy Outcome Predicted by Brain ...
The authors examined brain systems relevant to emotional reactivity and regulation, constructs that are thought to be central to PTSD and exposure therapy ...
NCT01391832 | Novel Treatment of Emotional Dysfunction ...
The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances ...
Multiphase Optimization Strategy (MOST) for Treating ...
The goal of this clinical trial is to test the extent to which different treatment components work to improve pediatric post-traumatic stress disorder ...
Using the multiphase optimization strategy to adapt cognitive ...
Importance of adapting CPT into a brief format. Approximately 10% of US military veterans [1, 2] suffer from posttraumatic stress disorder (PTSD) ...
Using the Multiphase Optimization Strategy to Adapt ...
The long-term goal of this line of research is to adapt, test, and implement brief, evidence-based treatment for Veterans with PTSD. The overall objective of ...
The efficacy of psychological interventions for child and ...
Abstract. Pediatric post-traumatic stress disorder (PTSD) is a common and debilitating mental disorder and its effective treatment ...
Using the multiphase optimization strategy to adapt cognitive ...
This factorial design will identify which CPT components contribute meaningfully to a reduction in PTSD symptoms.
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