Problem-Solving Skills Training for Parents of Children Undergoing Hematopoietic Stem Cell Transplantation: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Feasibility of Bright IDEAS for parents
研究概览
简要总结
The goal of this clinical trial is to test the feasibility and acceptability of the Bright IDEAS problem-solving skills training (PSST) intervention for parents of children undergoing hematopoietic stem cell transplantation (HSCT). The main question aims to answer:
- Determine the feasibility and acceptability of a multimodal PSST intervention for English and Spanish-speaking parents of children and adolescents undergoing autologous and allogeneic HSCT using a randomized controlled trial design and mixed methods approach to evaluation
- To evaluate the effectiveness of a PSST intervention on PSS acquisition and psychological distress compared to a control group of parents receiving non-directive psychosocial care (n=25).
- To explore the effect of the parent PSST on child quality of life (QoL) and self-reported symptoms, mediated by parent psychological distress
If there is a comparison group: Researchers will compare PSST intervention usual or standard psychosocial care.
Participants will complete 6-8 sessions of intervention. All participants will complete surveys.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Male and females of any race or ethnicity, ages 0 to 21 years
- •Allogeneic or autologous HSCT planned with reduced intensity or myeloablative conditioning
排除标准
- •Concurrent enrollment on a research study testing psychoeducational interventions for parents and/or patients
- •Inclusion Criteria:
- •One parent or primary caregiver per child
- •Able to speak, read, and write English or Spanish, and give informed consent
- •Exclusion Criteria:
- •Child or adolescent refusal to participate
- •Parent age less than 18 years.
研究组 & 干预措施
Problem-Solving Skills Training
Bright ideas problem solving skills intervention.
干预措施: Bright Ideas Problem-Solving Skills Training (Behavioral)
Control
Standard of care.
结局指标
主要结局
Feasibility of Bright IDEAS for parents
时间窗: Baseline to 180 days
Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.
Bright IDEAS Acceptability
时间窗: Between day 60 and day 90
Qualitative Interviews will assess participant satisfaction with the intervention format, timing, and content; impact; barriers; and suggestions for refinement.
次要结局
- Parent Negative Affectivity(Baseline to 180 days)
- Children Symptom Burden(Baseline to 180 days)
- Parent Problem Solving Skills(Baseline to 180 days)
- Parent Anxiety(Baseline to 180 days)
- Parent Depression(Baseline to 180 days)
- Parent Post-traumatic Stress(Baseline to 180 days)
- Children Health-Related Quality of Life(Baseline to 180 days)
研究者
Bemis, Heather
Assistant Professor of Clinical Pediatrics
Children's Hospital Los Angeles