Predictors & Mechanisms of Adolescent PTSD

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Exposure; Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Repeated imaginal exposure: Script Driven Imagery (SDI) task

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rachel Siciliano, Ph.D.; Phone Number: 843-792-3629; Email: siciliar@musc.edu
• Study Contact Backup: Name: Carla Kmett Danielson, Ph.D.; Phone Number: 843-792-3599; Email: danielso@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Contact: Carla Kmett Danielson, Ph.D.; Phone Number: 843-792-3599; Email: danielso@musc.edu
      • Principal Investigator: Rachel Siciliano, Ph.D.
      • Contact: Rachel Siciliano, Ph.D.; Phone Number: 8437923629; Email: siciliar@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Adolescent Inclusion Criteria:

1. Adolescent of any sex, race, or ethnicity; between the ages of 14 and 18 years old.
2. 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.
3. 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.
4. 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.
5. 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:

1. Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.
2. Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
3. 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.
4. Individuals on psychotropic medications must be stabilized on the medication for at least four weeks prior to study start date.
5. Individuals currently engaged in trauma-focused, exposure-based treatment.

Caregiver Inclusion Criteria:

1. Caregiver, parent, or legal guardian of an adolescent between the ages of 14 and 18 years old.
2. Ability to comprehend English.

Caregiver Exclusion Criteria:

1. Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure Arm	Behavioral: Repeated imaginal exposure: Script Driven Imagery (SDI) task; Repeated administration (5 repetitions) of a script including details of the individual's exposure to a traumatic event.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
State Anxiety (State and Trait Anxiety Inventory for Children - State Scale)	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	During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Heart Rate Reactivity During Script-Driven Imagery	During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)
Skin Conductance Reactivity During Script-Driven Imagery	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)	Baseline (Visit 1) and 1 month after baseline (Visit 3)

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjective units of distress (SUDS)	Visit 1 (baseline) to Visit 2 (1 week)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Trauma Exposure; Adolescent PTSD
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; potassium channel subfamily K member 3
• Other Study ID Numbers: Pro00149051; 1K23MH141303-01A1 (Other Grant/Funding Number: National Institute of Mental Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data from the K23 study will be made available to other researchers upon request after the completion of the K23 major aims papers, and available for 5 years after that date.
• IPD Sharing Access Criteria: Data from the K23 study will be made available to other researchers upon written request stating the investigators names, affiliated institution, and proposed specific research question. Investigators should 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No