Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of Bright IDEAS for parents
研究概览
简要总结
The goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright IDEAS problem solving skills training for parents of children in palliative care. The main questions it aims to answer are:
- Is bright IDEAS problem solving skills training feasible and acceptable for parents of children referred to pediatric palliative care?
- Does bright IDEAS reduce psychological distress in parents compared to parents receiving standard palliative care support?
Participants will:
- Participate in 6-8 sessions of the bright IDEAS program.
- Complete self report measures of psychological distress and well being.
If there is a comparison group: Researchers will compare bright IDEAS to standard palliative care support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents or legal guardians of male and female children (ages 0-21) of any race or ethnicity and of any underlying medical diagnosis
- •Child received at least one consult from the Comfort and Palliative Care team within the past month
- •One parent or primary caregiver per child
- •Able to speak, read, and write English or Spanish, and give informed consent
排除标准
- •Parent age less than 18 years old
- •Concurrent enrollment on another research study testing psychoeducational interventions for parents and/or patients
- •Child has an estimated life expectancy of less than 4 months at time of study recruitment
- •Inclusion Criteria:
- •Children 8-17 years of age whose primary caregiver has consented to participate
- •Able to read and write English or Spanish and assent
- •Exclusion Criteria:
- •Parent refusal to participate
结局指标
主要结局
Feasibility of Bright IDEAS for parents
时间窗: Baseline to 12 weeks
Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.
Parent Problem-Solving skills
时间窗: Baseline to 16 weeks
Social Problem-Solving Inventory-Revised Short Form. This is a a 25-item self-report instrument that measures five dimensions of problem-solving (positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style) using a five-point Likert scale (0 = "Not at All True of Me" to 4 = "Extremely True of Me"). Summary scores for each subscale as well as a Total Raw Score range from 0-20. Higher scores indicate better self-reported problem-solving skills.
Depression symptoms
时间窗: Baseline to 16 weeks
PROMIS® Depression Short Form-v 1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of depressive symptoms.
Traumatic stress symptoms
时间窗: Baseline to 16 weeks
Abbreviated Posttraumatic Checklist -Civilian Version (PCL-6). This is a 6-item self-report screening measure empirically derived from the PCL-C, consisting of the most highly responsive items from each of the reexperiencing, avoidance, and hyperarousal symptom domains of the PCL-C and has previously been used with parents of children with serious illness. The PCL-6 uses a five-point Likert scale (0 = "Not at all" to 5 = "Extremely"), with total scores ranging from 6-30. Higher scores indicate higher levels of traumatic stress symptoms.
Anxiety symptoms
时间窗: Baseline to 16 weeks
PROMIS® Anxiety Short Form-v1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of anxiety.
次要结局
- Child Quality of Life (QoL) Parent Proxy 0-7 years old(Baseline to 16 weeks)
- Parent Wellbeing(Baseline to 16 weeks)
- Child Quality of Life (QoL) Parent Proxy 8+ years old(Baseline to 16 weeks)
- Child Quality of Life (QoL) Child Self-Report(Baseline to 16 weeks)
研究者
Bemis, Heather
Principal Investigator
Children's Hospital Los Angeles