Müller Anne D, Gjøde Ida C T, Eigil Mette S, Busck Helle, Bonne Merete, Nordentoft Merete, Thorup Anne A E
Research Unit, Child and Adolescent Mental Health Center, Lersø Parkallé 107, 1 th, 2100, Copenhagen, Capital Region of Denmark, Denmark.
Mental Health Center, Copenhagen, Capital Region of Denmark, Denmark.
Trials. 2019 Feb 8;20(1):112. doi: 10.1186/s13063-019-3191-0.
Children born to parents with a severe mental illness, like schizophrenia, bipolar disorder, or major recurrent depression, have an increased risk of developing a mental illness themselves during life. These children are also more likely to have developmental delays, cognitive disabilities, or social problems, and they may have a higher risk than the background population of experiencing adverse life events. This is due to both genetic and environmental factors, but despite the well-documented increased risk for children with a familial high risk, no family-based early intervention has been developed for them. This study aims to investigate the effect of an early intervention that focuses on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.
METHODS/DESIGN: The study is a randomized clinical trial with 100 children aged 6-12 with familial high risk. It is performed in the context of the Danish health-care system. Families will be recruited from registers or be referred from the primary sector or hospitals. The children and their parents will be assessed at baseline and thereafter randomized and allocated to either treatment as usual or VIA Family. The intervention group will be assigned to a multidisciplinary team of specialists from adult mental health services, child and adolescent mental health services, and social services. This team will provide the basic treatment elements: case management, psychoeducation for the whole family, parental training, a safety plan, and potentially an early intervention if the child has mental problems. The study period is 18 months for both groups, and all participants will be assessed at baseline and after 18 months. The primary outcome measure will be daily functioning of the child, and the secondary measures are the psychopathology of the child, days of absence from school, family functioning, child's home environment, and parental stress.
This study is to our knowledge the first to explore the effects of a multidisciplinary team intervention that provides an intensive and flexible support to match the families' needs for children with a familial high risk for severe mental illness. The study will provide important knowledge about the potential for increasing resilience and reducing risk for children by supporting the whole family. However, a longer follow-up period may be needed.
ClinicalTrials.gov, NCT03497663 . Registered on 13 April 2018.
父母患有严重精神疾病（如精神分裂症、双相情感障碍或重度复发性抑郁症）的儿童，其一生中患精神疾病的风险会增加。这些儿童也更有可能出现发育迟缓、认知障碍或社会问题，并且他们经历不良生活事件的风险可能高于一般人群。这是由遗传和环境因素共同导致的，但尽管有充分记录表明有家族高风险的儿童患病风险增加，但尚未为他们开发基于家庭的早期干预措施。本研究旨在调查一项早期干预措施对于至少有一位父母患有严重精神疾病的家庭中儿童的影响，该干预措施侧重于降低风险并增强其恢复力。
方法/设计：本研究是一项随机临床试验，对象为100名6至12岁有家族高风险的儿童。研究在丹麦医疗保健系统的背景下进行。家庭将从登记册中招募，或由初级部门或医院转介。儿童及其父母将在基线时接受评估，然后随机分配到常规治疗组或“通过家庭”（VIA Family）干预组。干预组将被分配到一个由成人心理健康服务、儿童和青少年心理健康服务以及社会服务领域的专家组成的多学科团队。该团队将提供基本治疗要素：病例管理、全家心理教育、家长培训、安全计划，以及如果儿童有心理问题可能进行的早期干预。两组的研究周期均为18个月，所有参与者将在基线时和18个月后接受评估。主要结局指标将是儿童的日常功能，次要指标包括儿童的精神病理学、缺课天数、家庭功能、儿童的家庭环境和家长压力。
据我们所知，本研究是首次探索多学科团队干预措施的效果，该干预措施提供密集且灵活的支持，以满足有严重精神疾病家族高风险儿童家庭的需求。该研究将提供重要知识，说明通过支持整个家庭来增强儿童恢复力和降低风险的潜力。然而，可能需要更长的随访期。
ClinicalTrials.gov，NCT03497663。于2018年4月13日注册。
