Predictors & Mechanisms of Adolescent PTSD

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• State Anxiety (State and Trait Anxiety Inventory for Children - State Scale) [Срок оценки: 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 [Срок оценки: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)]
• Heart Rate Reactivity During Script-Driven Imagery [Срок оценки: During script-driven imagery tasks at baseline (Visit 1) and 1 week after baseline (Visit 2)]
• Skin Conductance Reactivity During Script-Driven Imagery [Срок оценки: 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) [Срок оценки: Baseline (Visit 1) and 1 month after baseline (Visit 3)]

Вторичные конечные точки (1)

• Subjective units of distress (SUDS) [Срок оценки: Visit 1 (baseline) to Visit 2 (1 week)]

Критерии участия

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:

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07537764 · Pro00149051 · 1K23MH141303-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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