Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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Optimizing Behavioral Health Services Following Pediatric Trauma Exposure

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
The Mt. Hope Family Center
RECRUITING
Rochester
Contact Information
Primary
Chad E Shenk, PhD
chad.shenk@rochester.edu
(585) 275-8704
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2028-08
Participants
Target number of participants: 200
Treatments
Experimental: Treatment Condition 1
Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation
Experimental: Treatment Condition 2
Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo
Experimental: Treatment Condition 3
Participants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 4
Participants receive emotion regulation, exposure, and psychological placebo
Experimental: Treatment Condition 5
Participants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 6
Participants receive emotion regulation, cognitive processing, and psychological placebo
Experimental: Treatment Condition 7
Participants receive emotion regulation, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 8
Participants receive emotion regulation and psychological placebo
Experimental: Treatment Condition 9
Participants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 10
Participants receive exposure, cognitive processing, and psychological placebo
Experimental: Treatment Condition 11
Participants receive exposure, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 12
Participants receive exposure and psychological placebo
Experimental: Treatment Condition 13
Participants receive cognitive processing, bi-lateral stimulation, and psychological placebo
Experimental: Treatment Condition 14
Participants receive cognitive processing and psychological placebo
Experimental: Treatment Condition 15
Participants receive bi-lateral stimulation and psychological placebo
Experimental: Treatment Condition 16
Participants receive psychological placebo
Related Therapeutic Areas
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov

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