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NCT Number: NCT07537764

Predictors & Mechanisms of Adolescent PTSD

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).

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. Corrugator Supercilii Electromyography (EMG) Reactivity

    Time frame: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)

  3. 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)

  4. 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)

  5. Posttraumatic Stress Disorder Symptoms (UCLA PTSD Reaction Index for DSM-5)

    Time frame: Baseline (Visit 1) and 1 month after baseline (Visit 3)

Secondary outcomes

  1. Subjective units of distress (SUDS)

    Time frame: Visit 1 (baseline) to Visit 2 (1 week)

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Kmett Danielson, Ph.D.

CONTACT

[email protected]

843-792-3599

Rachel Siciliano, Ph.D.

CONTACT

[email protected]

843-792-3629

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Identifying Biobehavioral Predictors and Targeting Mechanisms of Intervention in Adolescent Posttraumatic Stress Disorder

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 17, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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