对儿童的性兴趣(SIC)是性侵犯的主要风险因素,然而,临床试验很少。本方案概述了一项随机对照试验(RCT),旨在研究氟西汀和认知行为疗法(CBT)在SIC寻求帮助的男性中的有效性。
■联系瑞典电话求助热线PrevenTell的成年男性将被筛选纳入其中,并被邀请在现场进行进一步评估。11名SIC男性(定义为DSM-5恋童癖障碍或hebephilia)将被随机分配(1:1:1比例)接受三种干预措施之一,为期14周:(1)互联网管理的心理教育计划(iPP),(2)iPP和添加氟西汀20-40mg或(3)iPP和添加互联网施用的CBT(iCBT)。排除标准包括严重的精神病,禁忌症治疗和增加动手性犯罪的风险。在基线时评估症状强度,预处理,连续12周每隔一周,和后处理。主要结果指标是儿童的性兴趣:当前评估量表(SIC:CAS),该量表量化与SIC相关的性行为以及感知的困扰和损害。次要结果包括性犯罪的动态风险因素的度量。
■对招募的最初20个月中收集的数据进行了分析,以预测需要筛选的个体数量,并估计数据收集阶段的可能长度。截至2022年3月至2023年11月,已有146名男性致电PrevenTell,并披露了对未成年人的性兴趣。预筛查后,110名男性被排除在试验之外。目前的SSRI治疗是排除的主要原因(n=24;22%),其次是动手性犯罪的风险增加(n=14;13%)。在现场接受筛查的31名男子中,26个被分配给任一iPP,iPP+氟西汀,或iPP+iCBT。征聘率表明,审判将在预先估计的时间框架内结束。
■这是SIC寻求帮助的男性人群中使用SSRI和iCBT治疗的第一个RCT。讨论了该试验的意义及其方法学优势和局限性。
UNASSIGNED: Sexual Interest in Children (SIC) is a major risk factor for sexual offending, yet clinical trials are sparse. The present protocol outlines a randomized controlled trial (RCT) that aims to investigate the effectiveness of fluoxetine and Cognitive Behavioral Therapy (CBT) in help-seeking men with SIC.
UNASSIGNED: Adult men contacting the Swedish telephone helpline PrevenTell are screened for inclusion and invited to further assessment on site. One hundred and eleven men with SIC (defined as DSM-5 pedophilic disorder or hebephilia) will be randomized (1:1:1 ratio) to receive one of three interventions for 14 weeks: (1) an internet-administered psychoeducational program (iPP), (2) iPP and the addition of fluoxetine 20-40 mg or (3) iPP and the addition of internet-administered CBT (iCBT). Exclusion criteria include severe psychiatric illness, contraindicating treatment and an elevated risk of committing hands-on sexual offences. Symptom intensity is assessed at baseline, pre-treatment, every other week for 12 weeks, and post treatment. The primary outcome measure is the Sexual Interest in Children: Current Assessment Scale (SIC: CAS) that quantifies sexual behaviors associated with SIC as well as perceived distress and impairment. Secondary outcomes include measures of dynamic risk-factors for committing sexual offences.
UNASSIGNED: The data collected during the initial 20 months of recruitment were analyzed to predict the required number of individuals to be screened and estimate the probable length of the data collection phase. As of March 2022 to November 2023, 146 men have called PrevenTell and disclosed a sexual interest in minors. Following pre-screening, 110 men were excluded from participation in the trial. Current SSRI therapy was the primary reason for exclusion (n = 24; 22%), followed by an elevated risk of committing hands-on sexual offences (n = 14; 13%). Among the 31 men who underwent the screening procedure on site, 26 were allocated to either iPP, iPP+fluoxetine, or iPP+iCBT. The recruitment rate indicates that the trial will be concluded within the pre-estimated timeframe.
UNASSIGNED: This is the first RCT of treatment with SSRI and iCBT in a population of help-seeking men with SIC. The significance of this trial and its methodological strengths and limitations are discussed.