Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intervention Implementation
研究概览
简要总结
This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers.
Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness.
Following RE-AIM guidelines, the investigators will assess:
- Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions)
- Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings.
To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers.
This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.
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
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 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 6 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.
- •Patient is over the age of 11
结局指标
主要结局
Intervention Implementation
时间窗: 1 month
Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
Change in PTSD Knowledge
时间窗: Day 0 baseline, 3 months
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Intervention Acceptability
时间窗: 1 month
Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
Intervention Engagement
时间窗: 1 month
Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Change in Self-Reported Arousal
时间窗: Day 0 baseline, 3 months
Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
次要结局
- Change in Depression Symptoms(Day 0 baseline, 3 months)
- Change in Anxiety Symptoms(Day 0 baseline, 3 months)
- Change in PTSD and Trauma Symptoms(Day 0 baseline, 3 months)
- Change in Positive Parenting Practices(Day 0 baseline, 3 months)
研究者
Lauren Ng, PhD
Principal Investigator
University of California, Los Angeles