Department of Child and Adolescent Psychiatry and Neurology, University Medical Centre Rostock, Gehlsheimer Str. 20, 18147, Rostock, Germany.
Department of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
BMC Public Health. 2020 Nov 25;20(1):1780. doi: 10.1186/s12889-020-09878-w.
Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11-17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up.
In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11-17 year old boys with MBID without any alcohol experience.
This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID.
German Clinical Trials Register, DRKS00014042 . Registered on March 19th 2018.
轻度至边缘智力障碍（MBID）的男孩一旦开始饮酒，就有特别大的风险以有害的方式饮酒。基于正念的干预措施已被证明可有效预防物质使用，但主要针对 MBID 的成年人。一项针对 11-17 岁男孩的正念导向干预措施将在一项随机对照试验中进行测试。研究目的是在 12 个月的随访中，调查与积极对照条件相比，这种新干预措施的益处。
在这项随机对照概念验证研究中，82 名在过去一年中曾饮酒的 MBID 男孩将被随机分配到 6 周的正念导向干预组或对照组，对照组接受剂量和长度相等的对照干预。干预组接受正念训练结合互动药物教育，而对照组则接受健康训练结合相同的教育。在意向治疗分析中，主要结果是在 12 个月的随访时间内，自我报告的首次干预后醉酒延迟，每周使用基于应用程序的简短问卷进行测量。次要结果是干预后 30 天内使用酒精、烟草和其他药物。还研究了神经生物学行为参数的变化，例如冲动控制、奖励预期和决策。其他次要结果涉及特质正念、情绪调节、心理病理症状、同伴网络、感知压力和生活质量。此外，还将建立一个前瞻性登记处，以记录无任何饮酒经历的 11-17 岁 MBID 男孩群体的特定数据。
这项研究为预防 MBID 男孩物质使用的正念导向计划的有效性提供了首次证据。
德国临床试验注册处，DRKS00014042。于 2018 年 3 月 19 日注册。
