研究方案：一项随机对照试验，调查针对自闭症谱系障碍青少年的性心理训练项目的效果。
Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.
作者信息
Visser Kirsten, Greaves-Lord Kirstin, Tick Nouchka T, Verhulst Frank C, Maras Athanasios, van der Vegt Esther J M
机构信息
Department of Child and Adolescent Psychiatry/psychology, Erasmus MC-Sophia, Wytemaweg 8, 3015 CN, Rotterdam, The Netherlands.
Yulius Organization for Mental Health, Dennenhout 1, 2994 GC, Barendrecht, The Netherlands.
出版信息
BMC Psychiatry. 2015 Aug 28;15:207. doi: 10.1186/s12888-015-0586-7.
BACKGROUND
Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group.
METHODS/DESIGN: The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3).
DISCUSSION
To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results.
TRIAL REGISTRATION
Dutch Trial Register NTR2860. Registered on 20 April 2011.
背景
先前的研究表明，患有自闭症谱系障碍（ASD）的青少年在性心理发展方面面临多种风险，且这些青少年获取有关青春期和性方面可靠信息的渠道有限，这凸显了对患有ASD的青少年在其性心理发展方面进行特定指导的必要性。很少有研究调查针对患有ASD的青少年的性心理培训项目的效果，迄今为止，尚无随机对照试验可用于研究针对该目标群体的性心理干预的效果。
方法/设计：本研究方案中描述的随机对照试验（RCT）旨在调查应对青少年培训（TTT）项目对患有ASD的青少年性心理发展的影响。这项平行临床试验在荷兰西南部进行，采用简单的等随机化设计，设有干预组和等待名单对照组。200名青少年及其父母参与本研究。我们在1年中的三个时间点使用自我报告以及父母报告问卷对两组参与者进行评估：基线时（T1）、治疗后（T2）和随访时（T3）。
讨论
据我们所知，当前研究是首个采用随机对照设计来研究针对患有ASD的青少年的性心理培训项目效果的研究。它具有一些方法学优势，即样本量大、一系列功能相关的结局测量指标、使用多个信息提供者以及标准化的研究和干预方案。同时也指出了所描述研究的一些局限性，例如未在两种治疗条件之间进行比较，以及未使用盲法观察测量来调查研究结果的生态效度。
试验注册
荷兰试验注册编号NTR2860。于2011年4月20日注册。
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