Block sizes achieved by stratum.

BackgroundYouth in sub-Saharan Africa are at high risk of substance use yet lack access to appropriate interventions. The goal of this project was to evaluate the feasibility of a definitive trial to explore efficacy of a peer-delivered single-session brief intervention (SSBI) for youth with substance use in Kenya.MethodsSeventy youth aged 15−24 years with moderate risk substance use were randomized to SSBI or to psychoeducation. Data was collected at baseline and month three. Primary outcomes: Feasibility criteria, e.g., study participation rate, proportion of participants willing to be randomized, and study completion rate. Strategies for recruitment in a future trial were collected using focus group discussions with the youth at month three. Secondary outcomes: (i) Change in substance use (Alcohol, Smoking & Substance Use Involvement Screening Test for Youth [ASSIST-Y] questionnaire), depression (Patient Health Questionnaire [PHQ-9]), anxiety (Generalized Anxiety Disorder [GAD-7 scale]), and quality of life (World Health Organization-Quality of Life Brief Version [WHO-QOL BREF]) scores between baseline and month 3; (ii) Fidelity to the intervention assessed using fidelity checklists.ResultsThis pilot met most of the predefined minimum requirements for feasibility. For instance, 96.9% of those meeting eligibility criteria consented to participate (benchmark was 80%), and 100% of those who consented were willing to be randomized to either study arm. Youth reported that young people who use substances can be most effectively recruited from community settings. The SSBI showed a small effect on reducing total ASSIST-Y (Standardized Mean Difference [SMD] −0.33 95% Confidence Interval [CI] −0.83,0.16) scores in the intervention group compared to the control. There was a moderate improvement in the quality of life for the intervention group compared to the control (SMD −0.41 CI −0.91,0.09). The intervention had no effect on depression (SMD 0.23 CI −0.27,0.72) and anxiety symptoms (SMD 0.70 CI 0.19,1.2) at month 3.ConclusionIt is feasible to conduct a randomized controlled trial of a peer-delivered SSBI for youth with moderate risk substance use in Kenya.Trial registrationClinicalTrials.gov NCT05545904 Registration date: 16/09/2022, https://clinicaltrials.gov/study/NCT05545904.

背景 撒哈拉以南非洲地区的青少年物质使用风险极高，却难以获得适宜的干预措施。本研究旨在评估一项确证性试验的可行性，该试验旨在探索肯尼亚针对物质使用青少年开展的同伴递送单次简短干预（single-session brief intervention, SSBI）的有效性。

方法 本研究纳入70名年龄在15~24岁、存在中等风险物质使用问题的青少年，将其随机分配至单次简短干预组或心理教育组。分别在基线及第3个月收集数据。主要结局指标包括可行性相关标准，如研究参与率、自愿接受随机分组的受试者占比及研究完成率。于第3个月通过与青少年开展焦点小组讨论，收集未来试验的招募策略相关信息。次要结局指标包括：① 基线及第3个月时，物质使用情况[采用青少年酒精、吸烟与物质使用卷入筛查量表（Alcohol, Smoking & Substance Use Involvement Screening Test for Youth, ASSIST-Y）评估]、抑郁症状[采用患者健康问卷（Patient Health Questionnaire, PHQ-9）评估]、焦虑症状[采用广泛性焦虑障碍量表（Generalized Anxiety Disorder, GAD-7 scale）评估]及生活质量[采用世界卫生组织生活质量简表（World Health Organization-Quality of Life Brief Version, WHO-QOL BREF）评估]的评分变化；② 采用干预保真度核查清单评估干预实施的保真度。

结果 本试点研究达到了大部分预先设定的可行性最低标准。例如，符合纳入标准的受试者中96.9%签署了知情同意书（预设基准值为80%），且所有签署同意书的受试者均自愿被随机分配至两个研究组之一。青少年表示，可通过社区场景最有效地招募物质使用青少年。与对照组相比，单次简短干预组的ASSIST-Y总分呈小幅下降[标准化均数差（Standardized Mean Difference, SMD）=-0.33，95%置信区间（Confidence Interval, CI）：-0.83~0.16]。与对照组相比，干预组的生活质量呈中等程度改善（SMD=-0.41，95%CI：-0.91~0.09）。第3个月时，该干预对抑郁症状（SMD=0.23，95%CI：-0.27~0.72）及焦虑症状（SMD=0.70，95%CI：0.19~1.2）无显著影响。

结论 在肯尼亚针对存在中等风险物质使用问题的青少年开展同伴递送单次简短干预的随机对照试验具备可行性。

试验注册 临床试验注册平台（ClinicalTrials.gov）编号：NCT05545904，注册日期：2022年9月16日，链接：https://clinicaltrials.gov/study/NCT05545904。