Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Self-Reported Arousal
研究概览
简要总结
There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to treatment as usual (TAU) participants.
The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=44 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will,
- Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction;
- Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to:
- Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient referred to the SHARK Program
- •Patients must be at least 12 years old
- •Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.
- •If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;
- •Patient is able to complete study activities in English.
排除标准
- •Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;
- •Inability to provide informed consent or assent, and/or complete procedures in English.
结局指标
主要结局
Change in Self-Reported Arousal
时间窗: Day 0 baseline, 10 months
Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)
Change in Trauma-Related Cognitions
时间窗: Day 0 baseline, 10 months
Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)
Change in Stress Management Skill Use
时间窗: Day 0 baseline, 10 months
Changes in PTSD related arousal levels measured Measure of Adolescent Coping Strategies (MACS; Total 0-102, higher scores indicate higher use of specified coping), and use of the breathing retraining techniques as measured by self-reports during in-session review.
Change in PTSD Knowledge
时间窗: Day 0 baseline, 10 months
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Intervention Implementation and Acceptability
时间窗: Day 0 baseline, 10 months
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth. Additionally, data will be collected regarding participant completion of therapy, no show rates, barriers to treatment, and attendance. Additionally, study therapists will complete qualitative and quantitative measures regarding intervention delivery feasibility and study protocols.
次要结局
- Change in PTSD Symptoms(Day 0 baseline, 10 months)
- Change in Functional Impairment(Day 0 baseline, 10 months)
- Change in Anxiety Symptoms(Day 0 baseline, 10 months)
- Change in pro-inflammatory cytokine biomarkers(Day 0 baseline, 10 months)
- Change in pro-inflammatory transcription factor activation(Day 0 baseline, 10 months)
- Change in Trauma Symptoms(Day 0 baseline, 10 months)
- Change in Adverse Childhood Experiences(Day 0 baseline, 10 months)
- Change in Substance Use(Day 0 baseline, 10 months)
- Change in Depression Symptoms(Day 0 baseline, 10 months)
研究者
Lauren Ng, PhD
Principal Investigator
University of California, Los Angeles