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

描述（由申请人提供）：我们之前的研究表明，接受造血干细胞移植（HSCT）的儿童的父母在HSCT住院期间报告了显著的痛苦水平，大约20%的父母在移植完成一年半后报告了临床显著的痛苦水平。我们的研究还评估了社会和认知过程在父母痛苦中的作用，这项工作已经确定了社会和认知过程是儿童HSCT后父母长期痛苦反应的重要预测因素。在此基础上，结合社会和认知加工理论，我们开发了父母社会认知加工干预（P-SCIP）。我们的试点干预试验表明，P-SCIP是有效的，并得到家长的积极评价。我们将评估P-SCIP在300名接受HSCT儿童的父母中减少短期和长期痛苦和育儿压力的功效。P-SCIP将在儿童HSCT住院期间进行，专门用于改善父母对移植经历的社交（例如，分享担忧）和认知（例如，接受）处理。干预包括五次面对面的会议，并配有交互式光盘。光盘是对面对面交流材料的补充，为家长提供了加强和深化他们对HSCT经验的认知和社会处理的机会。在拟议的试验中，我们将开发P-SCIP的CD-ROM组件，然后进行P-SCIP的全面随机临床试验。该干预措施将与美国四个强化儿童HSCT设置中可用的最佳实践心理社会护理（BPC）进行测试。P-SCIP将同时提供给讲西班牙语和英语的家长。参与者将在HSCT时、HSCT后2个月、6个月和12个月完成心理困扰、幸福感、社会和认知加工的测量。研究问题将探讨P-SCIP与BPC对父母心理适应和社会认知加工的影响，以及评估父母个人资源和儿童医学课程变量对干预反应的影响。我们还将通过比较拒绝参与试验的父母和接受试验的父母的参与障碍来检查参与干预的障碍。本研究对改善接受HSCT儿童父母的生活质量和护理质量具有临床意义，同时也对设计潜在有效和可传播的心理社会干预措施具有临床意义，适用于患有其他身体疾病儿童的父母和照顾者。

DESCRIPTION (provided by applicant): Our prior research has indicated that parents of children undergoing hematopoietic stem cell transplant (HSCT) report significant levels of distress during HSCT hospitalization and that approximately twenty percent of parents report clinically-significant levels of distress one and a half years after transplant is complete. Our research has also evaluated the role of social and cognitive processes in parent distress and this work has identified social and cognitive processes that are important predictors of parents' long-term distress responses after pediatric HSCT. Based on this work and social and cognitive processing theory, we have developed a parent social-cognitive processing intervention (P-SCIP). Our pilot intervention trial indicated P-SCIP was efficacious and positively evaluated by parents. We 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. In the proposed trial, we will develop the CD-ROM component of P-SCIP and then conduct a full-scale randomized clinical trial of P-SCIP. 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. We 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. The proposed study has clinical implications for improving the quality of life and the quality of care for parents of children undergoing HSCT as well as implications for the design of potentially effective and disseminable psychosocial interventions for parent caregivers of children with other physical illnesses.