Anxiety & Depression Association of America

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

Purpose

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

Conditions

PTSD
Trauma
Pediatric ALL

Eligibility

Eligible Ages: Between 8 Years and 17 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2^4 Full Factorial Randomized Clinical Trial
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Independent and masked raters of treatment fidelity; Independent and masked raters of processes of change during active treatment

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment Condition 1	Participants receive emotion regulation, exposure, cognitive processing, and bi-lateral stimulation	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Experimental Treatment Condition 2	Participants receive emotion regulation, exposure, cognitive processing, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 3	Participants receive emotion regulation, exposure, bi-lateral stimulation, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 4	Participants receive emotion regulation, exposure, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 5	Participants receive emotion regulation, cognitive processing, bi-lateral stimulation, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 6	Participants receive emotion regulation, cognitive processing, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 7	Participants receive emotion regulation, bi-lateral stimulation, and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 8	Participants receive emotion regulation and psychological placebo	Behavioral: Emotion Regulation Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 9	Participants receive exposure, cognitive processing, bi-lateral stimulation, and psychological placebo	Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 10	Participants receive exposure, cognitive processing, and psychological placebo	Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 11	Participants receive exposure, bi-lateral stimulation, and psychological placebo	Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 12	Participants receive exposure and psychological placebo	Behavioral: Exposure Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 13	Participants receive cognitive processing, bi-lateral stimulation, and psychological placebo	Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 14	Participants receive cognitive processing and psychological placebo	Behavioral: Cognitive Processing Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 15	Participants receive bi-lateral stimulation and psychological placebo	Behavioral: Bi-lateral Stimulation Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Experimental Treatment Condition 16	Participants receive psychological placebo	Behavioral: Psychological Placebo Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Rochester

Study Contact

Chad E Shenk, PhD
(585) 275-8704
chad.shenk@rochester.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.