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水平的痛苦，并且大约20%的父母在移植完成后一年半报告了临床显著水平的痛苦。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科HSCT后父母长期痛苦反应的重要预测因素。基于这项工作和社会和认知加工理论，我们已经开发了一个家长社会认知加工干预（P-SCIP）。我们的初步干预试验表明，P-SCIP是有效的，并积极评价家长。我们将在300名接受HSCT的儿童父母中评估P-SCIP在减轻短期和长期痛苦和养育压力方面的疗效。P-SCIP将在儿童HSCT住院期间提供，专门用于改善父母的社交（例如，共享关注）和认知（例如，接受）移植经验的处理。干预包括五个面对面的会议，伴随着一个互动的CD-ROM。CD-ROM补充了面对面会议的材料，并为家长提供了机会，以提高和深化他们的认知和社会处理的HSCT的经验。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。该干预措施将根据美国四个丰富的儿科HSCT环境中可用的最佳实践心理社会护理（BPC）进行测试。P-SCIP将提供给讲西班牙语和英语的父母。参与者将在HSCT时，HSCT后两个月，六个月和十二个月完成心理困扰，幸福感以及社会和认知处理的测量。研究问题将解决P-SCIP与BPC对父母心理适应和社会认知处理的影响，以及评估父母的个人资源以及有助于干预反应的儿童医学课程变量。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之间的参与障碍来检查参与干预的障碍。这项研究对改善接受HSCT儿童的父母的生活质量和护理质量具有临床意义，并对设计潜在有效和可传播的心理社会干预措施对患有其他身体疾病的儿童的父母护理人员具有影响。与公共卫生的相关性 为接受造血干细胞移植（HSCT）的儿童提供护理是一项 非常紧张的经历。我们之前的研究表明， 在HSCT期间为孩子提供初级护理的母亲被诊断为 抑郁或焦虑相关障碍或经历中度至重度 移植时出现抑郁或焦虑症状。新颖、有效、实用， 以及可接受的干预措施，以减少HSCT期间和之后的父母痛苦， 预防长期持续的创伤性压力是必要的。使用认知和社会 加工理论，我们已经能够确定关键的认知和社会过程， 这有助于在一个大型的纵向观察研究的痛苦反应， 父母照顾者的群体。在拟议的研究中，我们沿着使用了这些信息 以理论指导父母社会认知处理干预的内容 程序（P-SCIP）。P-SCIP将面对面会议与互动CD结合在一起- 罗我们将在300例随机临床试验中评估P-SCIP的疗效。 接受HSCT的儿童的父母。

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. Relevance to Public Health Providing care for a child undergoing hematopoietic stem cell transplant (HSCT) is an extremely stressful experience. Our prior research indicates that between 20% and 30% of mothers providing primary care to their children during HSCT are diagnosed with either a depressive or anxiety-related disorder or experience moderate to severe symptoms of depression or anxiety at the time of transplant. Novel, efficacious, practical, and acceptable interventions to reduce parent distress during and after HSCT and prevent long-term, persistent traumatic stress are needed. Using cognitive and social processing theory, we have been able to identify key cognitive and social processes which contribute to distress reactions in a longitudinal observational study of a large group of parent caregivers. For the proposed study, we have used this information along with theory to guide the content of a Parent Social-Cognitive Processing Intervention Program (P-SCIP). P-SCIP incorporates in-person sessions with an interactive CD- ROM. We will evaluate the efficacy of P-SCIP in a randomized clinical trial of 300 parents of children undergoing HSCT.