Posttraumatic Stress Disorder (PTSD)Early Phase 1NCT07537764
Predictors & Mechanisms of Adolescent PTSD
A Early Phase 1 study testing Repeated imaginal exposure: Script Driven Imagery (SDI) task in people with Posttraumatic Stress Disorder (PTSD) and Trauma Exposure, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Trauma Exposure
- What is being tested?
- Repeated imaginal exposure: Script Driven Imagery (SDI) task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Mar 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Adolescent Inclusion Criteria:
- Adolescent of any sex, race, or ethnicity; between the ages of 14 and 18 years old.
- Accompaniment by a caregiver willing to participate. Note: Adolescents aged 18 years old are able to provide their own consent though still require caregiver participation to be eligible for study participation.
- Ability to comprehend English. Rationale: Public census data indicates that the overwhelming majority of youth in the local community are English-speaking (>98%), inclusive of multi-lingual households.
- Endorsement of exposure to one or more potentially traumatic event(s), as defined by DSM-5 Criterion A event, that the adolescent remembers and is able to verbalize.
- A total score ≥15 on the Child and Adolescent Trauma Screen (CATS) or report at least one clinically significant symptom on Intrusion/Re-experiencing, Avoidance, and Hyperarousal symptom domains, as defined by DSM-5 PTSD criteria, and one area of impairment.
Adolescent Exclusion Criteria:
- Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.
- Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
- Active suicide risk with ideation, plan and intent and/or recent (past 6 months) hospitalization for suicidality. These individuals will be referred directly for immediate services and treatment. All participants who endorse suicidal ideation will be engaged in safety planning as part of the study protocol.
- Individuals on psychotropic medications must be stabilized on the medication for at least four weeks prior to study start date.
- Individuals currently engaged in trauma-focused, exposure-based treatment.
Caregiver Inclusion Criteria:
- Caregiver, parent, or legal guardian of an adolescent between the ages of 14 and 18 years old.
- Ability to comprehend English.
Caregiver Exclusion Criteria:
- Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
Rachel Siciliano, Ph.D., 843-792-3629, siciliar@musc.edu
Carla Kmett Danielson, Ph.D., 843-792-3599, danielso@musc.edu
About this study
Official title: Identifying Biobehavioral Predictors and Targeting Mechanisms of Intervention in Adolescent Posttraumatic Stress Disorder
This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally experienced stressful or traumatic event using a script-driven imagery task.
The study evaluates whether repeated imaginal exposure is associated with changes in anxiety and physiological responses across sessions, and whether baseline patterns of threat reactivity and emotion regulation are associated with individual differences in response to the exposure task. Outcomes include self-reported anxiety, subjective distress ratings, and psychophysiological indices such as heart rate, skin conductance, and electromyographic activity.
The goal of this research is to improve understanding of biobehavioral processes related to trauma exposure in adolescents and to identify potential predictors of response to exposure-based intervention components relevant to posttraumatic stress disorder (PTSD).
- Being tested
- Repeated imaginal exposure: Script Driven Imagery (SDI) task
- Keywords
- Adolescent PTSD, Trauma Exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated imaginal exposure: Script Driven Imagery (SDI) taskBehavioural
Repeated administration (5 repetitions) of a script including details of the individual's exposure to a traumatic event.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Arm | Experimental | Not described Receives: Behavioral: Repeated imaginal exposure: Script Driven Imagery (SDI) task |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety (State and Trait Anxiety Inventory for Children - State Scale)
Measured: Baseline (Visit 1, prior to first script-driven imagery task) and 1 week after baseline (Visit 2, following repeated imaginal exposure)
Corrugator Supercilii Electromyography (EMG) Reactivity
Measured: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Heart Rate Reactivity During Script-Driven Imagery
Measured: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Skin Conductance Reactivity During Script-Driven Imagery
Measured: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Posttraumatic Stress Disorder Symptoms (UCLA PTSD Reaction Index for DSM-5)
Measured: Baseline (Visit 1) and 1 month after baseline (Visit 3)
Secondary outcomes (1)
Subjective units of distress (SUDS)
Measured: Visit 1 (baseline) to Visit 2 (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537764
- Sponsor's protocol ID
- Pro00149051
- Other IDs
- 1K23MH141303-01A1
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set will use unique identifier numbers that are not related to any personal identifying information. After the completion of the K23 major aims papers, data from the K23 study will be made available to other researchers upon request. A written request should state the investigators names, affiliated institution, and proposed specific research question. Investigators should also submit a conflict of interest statement. To gain access to the data, the investigator making the request must provide: (1) agreement to use data only for research purposes; (2) a commitment not to identify any individual participant (information will be de-identified); (3) a promise to secure the data according to NIMH, institutional, and IRB guidelines to ensure data safety and participant confidentiality; and (4) a commitment to destroy or return the data after the specified analyses are completed. All data sharing will follow the guidelines and rules of the NIH and IRB.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biobehavioral Predictors and Targeting Mechanisms of Intervention in Adolescent Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07537764
- Acronym / sponsor ID
- Pro00149051
- Keywords
- Adolescent PTSD, Trauma Exposure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines how adolescents with trauma-related symptoms respond to stress and strong emotions. The study assesses brain activity, physiological responses, and behavior during experimental tasks that involve responding to potential threats, regulating emotions, and repeatedly imagining details of a personally experienced stressful or traumatic event using a script-driven imagery task.
The study evaluates whether repeated imaginal exposure is associated with changes in anxiety and physiological responses across sessions, and whether baseline patterns of threat reactivity and emotion regulation are associated with individual differences in response to the exposure task. Outcomes include self-reported anxiety, subjective distress ratings, and psychophysiological indices such as heart rate, skin conductance, and electromyographic activity.
The goal of this research is to improve understanding of biobehavioral processes related to trauma exposure in adolescents and to identify potential predictors of response to exposure-based intervention components relevant to posttraumatic stress disorder (PTSD).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure Arm | Experimental | Behavioral: Repeated imaginal exposure: Script Driven Imagery (SDI) task |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated imaginal exposure: Script Driven Imagery (SDI) taskRepeated administration (5 repetitions) of a script including details of the individual's exposure to a traumatic event. | Behavioural | Exposure Arm |
Primary outcome
State Anxiety (State and Trait Anxiety Inventory for Children - State Scale)
Time frame: Baseline (Visit 1, prior to first script-driven imagery task) and 1 week after baseline (Visit 2, following repeated imaginal exposure)
Corrugator Supercilii Electromyography (EMG) Reactivity
Time frame: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Heart Rate Reactivity During Script-Driven Imagery
Time frame: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Skin Conductance Reactivity During Script-Driven Imagery
Time frame: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Posttraumatic Stress Disorder Symptoms (UCLA PTSD Reaction Index for DSM-5)
Time frame: Baseline (Visit 1) and 1 month after baseline (Visit 3)
1 secondary outcome
Subjective units of distress (SUDS)
Time frame: Visit 1 (baseline) to Visit 2 (1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. A de-identified data set will use unique identifier numbers that are not related to any personal identifying information. After the completion of the K23 major aims papers, data from the K23 study will be made available to other researchers upon request. A written request should state the investigators names, affiliated institution, and proposed specific research question. Investigators should also submit a conflict of interest statement. To gain access to the data, the investigator making the request must provide: (1) agreement to use data only for research purposes; (2) a commitment not to identify any individual participant (information will be de-identified); (3) a promise to secure the data according to NIMH, institutional, and IRB guidelines to ensure data safety and participant confidentiality; and (4) a commitment to destroy or return the data after the specified analyses are completed. All data sharing will follow the guidelines and rules of the NIH and IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Repeated imaginal exposure: Script Driven Imagery (SDI) task in people with Posttraumatic Stress Disorder (PTSD) and Trauma Exposure, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Siciliano, Ph.D. (843-792-3629, siciliar@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (State and Trait Anxiety Inventory for Children - State Scale) (time frame: Baseline (Visit 1, prior to first script-driven imagery task) and 1 week after baseline (Visit 2, following repeated imaginal exposure)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.