Multiphase Optimization Strategy (MOST) for Treating Pediatric Post-traumatic Stress Disorder (PTSD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorUniversity of Rochester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
Emotion Regulation
BehavioralParticipants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
Exposure
BehavioralParticipants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
Cognitive Processing
BehavioralParticipants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
Bi-lateral Stimulation
BehavioralParticipants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
Psychological Placebo
BehavioralParticipants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Treatment groups
200 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Treatment Condition 1Experimental treatment 4 interventions
Group B: Treatment Condition 2Experimental treatment 4 interventions
Group C: Treatment Condition 3Experimental treatment 4 interventions
Group D: Treatment Condition 4Experimental treatment 3 interventions
Group E: Treatment Condition 5Experimental treatment 4 interventions
Group F: Treatment Condition 6Experimental treatment 3 interventions
Group G: Treatment Condition 7Experimental treatment 3 interventions
Group H: Treatment Condition 8Experimental treatment 2 interventions
Group I: Treatment Condition 9Experimental treatment 4 interventions
Group J: Treatment Condition 10Experimental treatment 3 interventions
Group K: Treatment Condition 11Experimental treatment 3 interventions
Group L: Treatment Condition 12Experimental treatment 2 interventions
Group M: Treatment Condition 13Experimental treatment 3 interventions
Group N: Treatment Condition 14Experimental treatment 2 interventions
Group O: Treatment Condition 15Experimental treatment 2 interventions
Group P: Treatment Condition 16Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA)
The CAPS-CA is a clinician-administered diagnostic interview measuring the severity of PTSD symptoms in the past month. The interview assesses 20 PTSD symptoms according to DSM-5 diagnostic criteria with each symptom rated on a severity scale ranging from 0 to 4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).
Time frame
Baseline (pre-treatment), Week 19 (post-treatment)2
Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS)
The CPSS is a child-report survey measuring the severity of PTSD symptoms in the past month. Survey items assess 20 PTSD symptoms according to DSM-5 diagnostic criteria with severity ratings for each item ranging from 0-4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).
Time frame
Baseline (pre-treatment), Week 19 (post-treatment)3
Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2)
The CATS-2 is a caregiver-reported survey measuring the frequency of pediatric PTSD symptoms in the past four weeks. Survey items assess 20 PTSD symptoms according to DSM-5 and ICD-11 diagnostic criteria with frequency ratings for each item ranging from 0-3. Ratings for each individual item are summed with higher scores indicating greater frequencies of PTSD symptoms (total scores range from 0-60).
Time frame
Baseline (pre-treatment), Week 19 (post-treatment)Secondary outcomes
1
Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA)
The CAPS-CA is a clinician-administered interview establishing the presence of a PTSD diagnosis according to DSM-5 diagnostic criteria. The presence of a PTSD diagnosis (yes/no) will be established before and after receiving treatment. Change in PTSD diagnostic status will be used to indicate treatment response.
Time frame
Baseline (pre-treatment), Week 19 (post-treatment)2
Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS)
The CPSS is a child-report survey measuring the severity of PTSD symptoms that will be modified to assess these symptoms in the time since the last treatment session. Survey items assess 20 PTSD symptoms according to DSM-5 diagnostic criteria with severity ratings for each item ranging from 0-4. Ratings for each individual symptom are summed with higher scores indicating greater severities of PTSD symptoms (total scores range from 0-80).
Time frame
Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)3
Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2)
The CATS-2 is a caregiver-reported survey measuring the frequency of pediatric PTSD symptoms that will be modified to assess these symptoms in the time since the last treatment session. Survey items assess 20 PTSD symptoms according to DSM-5 and ICD-11 diagnostic criteria with frequency ratings for each item ranging from 0-3. Ratings for each individual item are summed with higher scores indicating greater frequencies of PTSD symptoms (total scores range from 0-60).
Time frame
Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment)4
Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2)
The CDI-2 is a child-report survey assessing the severity of twenty-eight mood disorder symptoms in the past two weeks. Responses are rated on a scale from 0-2 and summed. Higher scores indicate greater severities of mood disorder symptoms (total raw scores range from 0-56). Raw scores can be converted to T-scores.
Time frame
Baseline (pre-treatment), Week 19 (post-treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov