Predictors & Mechanisms of Adolescent PTSD

NCT07537764 | Not Yet Recruiting Early Phase 1 DMC

• 2 other identifiers: Pro001490511K23MH141303-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Trauma Exposure; Posttraumatic Stress Disorder (PTSD)

Keywords

Adolescent PTSD; Trauma Exposure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Subjective units of distress (SUDS)

  Visit 1 (baseline) to Visit 2 (1 week)

Study Arms (1)

Exposure Arm

EXPERIMENTAL

Behavioral: Repeated imaginal exposure: Script Driven Imagery (SDI) task

Interventions

Repeated imaginal exposure: Script Driven Imagery (SDI) task BEHAVIORAL

Repeated administration (5 repetitions) of a script including details of the individual's exposure to a traumatic event.

Exposure Arm

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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, parent, or legal guardian of an adolescent between the ages of 14 and 18 years old.
• Ability to comprehend English.
• \. Previous diagnosis indicating intellectual disability or pervasive developmental disorder that would preclude participant from understanding study procedures.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Rachel Siciliano, Ph.D.

CONTACT

843-792-3629; siciliar@musc.edu

Carla Kmett Danielson, Ph.D.

CONTACT

843-792-3599; danielso@musc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)