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临床试验/NCT00939380
NCT00939380已完成不适用

Facilitating Parent Adaptation to Pediatric Transplant: The P-SCIP Trial

Rutgers, The State University of New Jersey8 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
8
主要终点
Beck Depression Inventory

研究概览

简要总结

The investigators have developed a parent social-cognitive processing intervention (P-SCIP) to help decrease distress among parent caregivers of children undergoing hematopoietic stem cell transplant (HSCT). The investigators will evaluate the efficacy of P-SCIP in reducing short- and long-term distress and parenting stress among 300 parents of children undergoing HSCT. P-SCIP will be delivered during the child's inpatient HSCT hospitalization and is specifically designed to improve parent social (e.g., sharing concerns) and cognitive (e.g., acceptance) processing of the transplant experience. The intervention includes five in-person sessions that are accompanied by an interactive CD-ROM. The CD-ROM complements the materials in the in-person sessions and provides parents with the opportunity to enhance and deepen their cognitive and social processing of the HSCT experience. The intervention will be tested against best-practices psychosocial care (BPC) available in four enriched pediatric HSCT settings across the United States. P-SCIP will be provided to both Spanish- and English-speaking parents. Participants will complete measures of psychological distress, well-being, and social and cognitive processing at the time of HSCT, two, six and twelve months after HSCT. Research questions will address the effects of P-SCIP versus BPC on parent psychological adaptation and social and cognitive processing, as well as evaluate parent personal resources as well as child medical course variables that contribute to intervention response. The investigators will also examine barriers to participation in the intervention by comparing barriers to participation among parents who refuse participation in the trial and parents who accept.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • biological or foster parent of children under 19 years of age who are scheduled for HSCT within the next month
  • participant is the primary caregiver
  • participant must have phone service
  • caregiver speaks, reads, and writes English or Spanish (Spanish is for Childrens Hospital Los Angeles and Columbia University only)

排除标准

  • pediatric patient has a diagnosis of medulloblastoma or other cancer of the brain

结局指标

主要结局

Beck Depression Inventory

时间窗: 7 years

Beck Anxiety Inventory

时间窗: 7 years

Mental Health Inventory

时间窗: 7 years

Impact of Events Scale-Revised

时间窗: 7 years

Axis I Structured Clinical Interview for DSM-IV (SCID)

时间窗: 7 years

次要结局

  • Fear Structure(7 years)
  • Brief COPE(7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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