Luijks Marie-Jolette A, Bevaart Floor, Zijlmans Josjan, van Duin Laura, Marhe Reshmi, Doreleijers Theo A H, Tiemeier Henning, Asscher Jessica J, Popma Arne
VU University Medical Center, Department of Child and Adolescent Psychiatry, Meibergdreef 5, 1105 AZ, Amsterdam, The Netherlands.
Erasmus Medical Center, Department of Epidemiology and Department of Child and Adolescent Psychiatry, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Trials. 2017 May 19;18(1):225. doi: 10.1186/s13063-017-1950-3.
Effective interventions for young adults with severe, multiple problems - such as psychosocial and psychiatric problems, delinquency, unemployment and substance use - are scarce but urgently needed in order to support an adequate transition to adulthood. A multimodal day treatment program called "New Opportunities" (in Dutch: "De Nieuwe Kans"; DNK) was specifically developed to target multi-problem young adults in The Netherlands. The aim of this study protocol is to describe the design of a randomized controlled trial (RCT) in clinical practice to examine the effectiveness of DNK in comparison with care as usual (CAU).
METHODS/DESIGN: Multi-problem young adults in Rotterdam, The Netherlands, will be assigned randomly to DNK (expected N = 150) and CAU (expected N = 150). Primary outcome measures are recidivism and self-sufficiency. Secondary outcome measures include quality of life, attending school/work, psychological functioning, cognitive distortions and substance use. Participant and program characteristics will be examined as potential moderators of effectiveness. Additionally, cost-effectiveness will be measured. During 14 months, data from multiple resources will be collected at four time points.
This study is one of the first RCTs on the effectiveness of interventions developed for multi-problem young adults. The results will contribute to the currently scant knowledge about what works for various multi-problem young adults in their transition to adulthood. In addition, the study protocol will provide insight into implementing an RCT in a dynamic setting of clinical practice.
Dutch Trial Register, identifier: NTR5163 . Registered on 17 April 2015; retrospectively registered during the recruitment phase.
针对有严重多种问题的年轻人，如心理社会和精神问题、犯罪、失业及药物使用等，有效的干预措施稀缺，但为支持其顺利过渡到成年，这类措施又迫切需要。一个名为“新机会”（荷兰语：“De Nieuwe Kans”；简称DNK）的多模式日间治疗项目专门为荷兰的多问题年轻人设计。本研究方案的目的是描述一项在临床实践中进行的随机对照试验（RCT）的设计，以检验DNK相较于常规护理（CAU）的有效性。
方法/设计：荷兰鹿特丹的多问题年轻人将被随机分配至DNK组（预计N = 150）和CAU组（预计N = 150）。主要结局指标是再犯率和自给自足情况。次要结局指标包括生活质量、上学/工作情况、心理功能、认知扭曲及药物使用情况。将研究参与者和项目特征作为有效性的潜在调节因素。此外，还将衡量成本效益。在14个月期间，将在四个时间点从多个来源收集数据。
本研究是首批针对为多问题年轻人开发的干预措施有效性的随机对照试验之一。研究结果将有助于补充目前关于何种措施对各类多问题年轻人过渡到成年有效的稀缺知识。此外，该研究方案将为在临床实践动态环境中实施随机对照试验提供见解。
荷兰试验注册库，标识符：NTR5163。于2015年4月17日注册；在招募阶段进行回顾性注册。
