Predictors & Mechanisms of Adolescent PTSD
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age14-18
SponsorMedical University of South Carolina
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Repeated imaginal exposure: Script Driven Imagery (SDI) task
BehavioralRepeated administration (5 repetitions) of a script including details of the individual's exposure to a traumatic event.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Exposure ArmExperimental treatment 1 intervention
Trial outcomes
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)Secondary outcomes
1
Subjective units of distress (SUDS)
Time frame
Visit 1 (baseline) to Visit 2 (1 week)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov
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