Pediatric ALL, PTSD, Trauma
Conditions
Keywords
PTSD, Trauma, Pediatric, Multiphase Optimization Strategy
Brief 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
Interventions
BEHAVIORALEmotion Regulation
Participants learn to reduce acute subjective distress, stabilize negative mood, promote positive mood, and alter physiological responses to trauma
BEHAVIORALExposure
Participants engage in written exercises to reduce avoidance of trauma reminders and reinforce approach behaviors consistent with personal goals
BEHAVIORALCognitive Processing
Participants learn ways to identify, challenge, and overcome the influence of cognitive distortions resulting from trauma exposure
BEHAVIORALBi-lateral Stimulation
Participants engage in horizontal eye movements while recalling a traumatic memory and describing their affective and physiological state
BEHAVIORALPsychological Placebo
Participants receive non-directive support therapy, where they will guide the treatment session but not be required to discuss prior trauma exposure
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Independent and masked raters of treatment fidelity; Independent and masked raters of processes of change during active treatment
Intervention model description
2\^4 Full Factorial Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA) | Baseline (pre-treatment), Week 19 (post-treatment) | 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). |
| Mean Change in PTSD Symptoms - Child PTSD Symptom Scale for DSM-5 (CPSS) | Baseline (pre-treatment), Week 19 (post-treatment) | 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). |
| Mean Change in PTSD Symptoms - Child and Adolescent Trauma Screen (CATS-2) | Baseline (pre-treatment), Week 19 (post-treatment) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Participants with a PTSD Diagnosis - The Clinician Administered PTSD Scale for DSM-5 - Child / Adolescent Version (CAPS-CA) | Baseline (pre-treatment), Week 19 (post-treatment) | 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. |
| Change in PTSD Symptom Trajectories - Child PTSD Symptom Scale for DSM-5 (CPSS) | Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment) | 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). |
| Change in PTSD Symptom Trajectories - Child and Adolescent Trauma Screen (CATS-2) | Baseline (pre-treatment), Weeks 1-18 (active treatment), Week 19 (post-treatment) | 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). |
| Mean Change in Mood Disorder Symptoms - Children's Depression Inventory-2 (CDI-2) | Baseline (pre-treatment), Week 19 (post-treatment) | 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. |
| Mean Change in Anxiety Disorder Symptoms - Screen for Child Anxiety Related Disorders (SCARED) | Baseline (pre-treatment, Week 19 (post-treatment) | The SCARED is a child-report survey assessing symptoms of five pediatric anxiety disorders (panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia) in the past three months. Responses assess the presence of 41 anxiety symptoms on a scale ranging from 0-2. Item responses are summed with higher scores indicating more severe anxiety symptoms (total scores range from 0-82). |
| Mean Change in Disruptive Behavior Disorder Symptoms - Child Behavior Checklist (CBCL) | Baseline (pre-treatment), Week 19 (post-treatment) | The CBCL is a caregiver-report survey measuring the frequency of child behavior problems in the past six months, including disruptive behavior disorder symptoms. There are 112 items rated on a scale of 0-2 with individual item ratings summed to indicate greater symptom frequency (total scores range from 0-238). Raw scores can be converted to T-scores. The externalizing disorders broadband scale and the DSM-oriented scales will be used to measure disruptive behavior disorder symptoms. |
| Change in PTSD, Mood, Anxiety, and Disruptive Behavior Disorder Symptom Trajectories - Ecological Momentary Assessment (EMA) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | A 29-item, once-daily EMA will be administered to children via smartphone application for a period of two-weeks at pre-treatment, mid-treatment, and post-treatment. Items assess the presence and duration of PTSD, mood, anxiety, and disruptive behavior disorder symptoms on a scale from 0-100. Higher scores indicate a longer duration of symptoms experienced for the day the survey is completed. |
| Changes in Trajectories of C-Reactive Protein (CRP) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | The Tasso+ device will be used to obtain whole blood samples. Tasso+ is an FDA 510(k)-approved, sterile, disposable blood lancing device approved for use by laypeople (e.g. caregiver, research staff). A sterile lancet punctures the skin with the press of a button that simultaneously creates a slight vacuum to help capillary blood flow into a compatible tube under gravity. Depending on blood yield, CRP will be assayed. |
| Changes in Trajectories of Interleukin-6 (IL-6) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | The Tasso+ device will be used to obtain whole blood samples. Tasso+ is an FDA 510(k)-approved, sterile, disposable blood lancing device approved for use by laypeople (e.g. caregiver, research staff). A sterile lancet punctures the skin with the press of a button that simultaneously creates a slight vacuum to help capillary blood flow into a compatible tube under gravity. Depending on blood yield, IL-6 will be assayed. |
| Changes in Trajectories of Tumor Necrosis Factor-Alpha | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | The Tasso+ device will be used to obtain whole blood samples. Tasso+ is an FDA 510(k)-approved, sterile, disposable blood lancing device approved for use by laypeople (e.g. caregiver, research staff). A sterile lancet punctures the skin with the press of a button that simultaneously creates a slight vacuum to help capillary blood flow into a compatible tube under gravity. Depending on blood yield, tumor necrosis factor-alpha will be assayed. |
| Brain Aging - Magnetic Resonance Imaging (MRI) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | MRIs will be performed to measure changes in brain aging, the difference between a participant's chronological age and biological age estimated through several established neural markers. Positive brain aging scores indicate faster brain aging. Negative brain aging scores indicate slower brain aging. |
| Change in Neural Structure - Magnetic Resonance Imaging (MRI) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | MRIs will be performed to measure changes in neural structures (e.g. hippocampal and amygdala volume) involved in memory retrieval as well as threat and fear processing associated with PTSD and treatment of PTSD. |
| Change in Network Connectivity - Magnetic Resonance Imaging (MRI) | Baseline (pre-treatment), A randomly selected two-week period during active treatment (Weeks 5-18), Week 19 (post-treatment) | MRIs will be performed to measure changes in network connectivity (e.g. default mode network) related to working memory performance, autobiographical recall, and fear processing. |
| Mean Change in Experiential Avoidance - Avoidance and Fusion Questionnaire for Youth (AFQ-Y) | Baseline (pre-treatment), Week 19 (post-treatment) | The AFQ-Y is a 17-item child report survey assessing experiential avoidance in the presence of aversive private stimuli. Items are anchored on a 0-4 scale with responses summed to indicate greater levels of avoidance (total scores range from 0-68). |
| Mean Change in Trauma-Related Cognitions - Child Post-Traumatic Cognitions Inventory (CPTCI) | Baseline (pre-treatment), Week 19 (post-treatment) | The CPTCI is a 25-item measure assessing the presence of different cognitions that may occur following exposure to pediatric trauma. Each item is ranked on a 1-4 scale with individual responses summed to indicate a greater number of trauma-related cognitions (total scores range from 25-100). |
| Mean Change in Emotion Transitions - Affect Transition Task | Baseline (pre-treatment), Week 19 (post-treatment) | Subjects rate the likelihood that a person would transition between two hypothetical affective states. In each trial, subjects are presented with two states connected by an arrow (e.g. happy - angry) and are informed that the state to the left of the arrow is the person's current state and the state on the right side of the arrow is a state the person might experience next. The states included are: hate, love, happy, hurt, mad, sad, scared, and tired. Subjects then rate the likelihood of that person making that transition on a continuous scale from 0-100% with higher scores indicating a greater likelihood of that transition. For a second set of tasks, subjects rate the similarity between each pair of states using a scale from 0-100% with higher ratings indicating greater similarity. Variation in the likelihood ratings for each paired states are examined across participants. |
| Mean Change Subclinical Psychosis - Prodromal Questionnaire Brief Child Version Screener (PQ-BC) | Baseline (pre-treatment), Week 19 (post-treatment) | The PQ-BC is a 21-item child-report survey assessing subclinical psychotic symptoms, including unusual beliefs and perceptual distortions in the past month. Each item assesses the presence of a subclinical psychotic symptom in a yes/no response format. A distress score, which weights the endorsed item by the level of distress experienced by that item on a scale of 0-6, is obtained for each of the 21 items. Total scores range from 0-126 with higher scores indicating greater distress. |
| Mean Change Transdiagnostic Psychiatric Symptoms - The Kiddie Schedule for Affective Disorders and Schizophrenia - Cross Cutting Symptoms (K-SADS-CC) | Baseline (pre-treatment), Week 19 (post-treatment) | The K-SADS-CC is a 21-item child-report survey assessing psychiatric symptoms common across different psychiatric disorders. Each item assesses the severity of a psychiatric symptom during the past two weeks on a scale of 0-4. Total scores range from 0-84 with higher scores indicating a greater severity of psychiatric symptoms. |
Countries
United States
Contacts
CONTACTChad E Shenk, PhD
PRINCIPAL_INVESTIGATORChad E Shenk, PhD
University of Rochester
Outcome results
None listed