BACKGROUND Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health (SEHER) is a multicomponent, whole-school health promotion intervention delivered by a lay counsellor or a teacher in government-run secondary schools in Bihar, India. The objective of this study is to examine the effects of the intervention after two years of follow-up and to evaluate the consistency of the findings observed over time. METHODS AND FINDINGS We conducted a cluster randomised trial in which 75 schools were randomised (1:1:1) to receive the SEHER intervention delivered by a lay counsellor (SEHER Mitra [SM]) or a teacher (Teacher as SEHER Mitra [TSM]), respectively, alongside a standardised, classroom-based life skills Adolescence Education Program (AEP), compared to AEP alone (control group). The trial design was a repeat cross-sectional study. Students enrolled in grade 9 (aged 13-15 years) in the 2015-2016 academic year were exposed to the intervention for two years and the outcome assessment was conducted at three time points─at baseline in June 2015; 8-months follow-up in March 2016, when the students were still in grade 9; and endpoint at 17-months follow-up in December 2016 (when the students were in grade 10), the results of which are presented in this paper. The primary outcome, school climate, was measured with the Beyond Blue School Climate Questionnaire (BBSCQ). Intervention effects were estimated using mixed-effects linear or logistic regression, including a random effect to adjust for within-school clustering, minimisation variables, baseline cluster-level score of the outcome, and sociodemographic characteristics. In total, 15,232 students participated in the 17-month survey. Compared with the control group, the participants in the SM intervention group reported improvements in school climate (adjusted mean difference [aMD] = 7.33; 95% CI: 6.60-8.06; p < 0.001) and most secondary outcomes (depression: aMD = -4.64; 95% CI: -5.83-3.45; p < 0.001; attitude towards gender equity: aMD = 1.02; 95% CI: 0.65-1.40; p < 0.001; frequency of bullying: aMD = -2.77; 95% CI: -3.40 to -2.14; p < 0.001; violence victimisation: odds ratio [OR] = 0.08; 95% CI: 0.04-0.14; p < 0.001; and violence perpetration: OR = 0.16; 95% CI: 0.09-0.29; p < 0.001). There was no evidence of an intervention effect in the TSM group compared with control group. The effects of the lay counsellor-delivered intervention were larger for most outcomes at 17-months follow-up compared with those at 8 months: school climate (effect size [ES; 95% CI] = 2.23 [1.97-2.50] versus 1.88 [1.44-2.32], p < 0.001); depression (ES [95% CI] = -1.19 [-1.56 to -0.82] versus -0.27 [-0.44 to -0.11], p < 0.001); attitude towards gender equity (ES [95% CI] = 0.53 [0.27-0.79] versus 0.23 [0.10-0.36], p < 0.001); bullying (ES [95% CI] = -2.22 [-2.84 to -1.60] versus -0.47 [-0.61 to -0.33], p < 0.001); violence victimisation (OR [95% CI] = 0.08 [0.04-0.14] versus 0.62 [0.46-0.84], p < 0.001); and violence perpetration (OR [95% CI] = 0.16 [0.09-0.29] versus 0.68 [0.48-0.96], p < 0.001), suggesting incremental benefits with an extended intervention. A limitation of the study is that 27% of baseline participants did not complete the 17-month outcome assessment. CONCLUSIONS The trial showed that the second-year outcomes were similar to the first-year outcomes, with no effect of the teacher-led intervention and larger benefits on school climate and adolescent health accruing from extending lay counsellor-delivered intervention. TRIAL REGISTRATION ClinicalTrials.gov NCT02907125.

中文翻译：

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一项多元的中学健康促进干预措施和青少年健康措施：在印度比哈尔邦进行的SEHER群集随机对照试验的扩展。

背景技术基于基于学校的青少年健康干预措施的强化证据是由多名顾问在印度比哈尔邦的公立中学中由非专业顾问或教师提供的全校健康促进干预措施。这项研究的目的是在两年的随访后检查干预措施的效果，并评估随时间推移所观察到的结果的一致性。方法和结果我们进行了一项整群随机试验，将75所学校随机分配（1：1：1），以接受由非专业顾问（SEHER Mitra [SM]）或老师（教师为SEHER Mitra [TSM]）进行的SEHER干预。 ）与标准化的，基于课堂的生活技能青少年教育计划（AEP）相比，与单独的AEP（对照组）相比。试验设计是重复的横断面研究。在2015-2016学年就读9年级（13至15岁）的学生接受了为期两年的干预，并在三个时间点（即2015年6月的基线）进行了结果评估；2016年3月，当学生仍在9年级时进行了8个月的随访；并在2016年12月（当学生处于10年级时）的17个月随访中达到终点，其结果在本文中进行介绍。主要结果是学校气候，是通过“超越蓝学校气候调查表”（BBSCQ）进行测量的。使用混合效应线性或逻辑回归评估干预效果，包括调整校内聚类的随机效应，最小化变量，基线聚类水平结局评分和社会人口统计学特征。总共15,232名学生参加了为期17个月的调查。与对照组相比，SM干预组的参与者报告了学校氛围的改善（调整后的平均差异[aMD] = 7.33； 95％CI：6.60-8.06； p <0.001）和大多数次要结局（抑郁：aMD =- 4.64; 95％CI：-5.83-3.45; p <0.001;对待性别平等的态度：aMD = 1.02; 95％CI：0.65-1.40; p <0.001;欺凌频率：aMD = -2.77; 95％CI：- 3.40至-2.14； p <0.001；暴力受害：优势比[OR] = 0.08； 95％CI：0.04-0.14； p <0.001；暴力行为：OR = 0.16； 95％CI：0.09-0.29； p < 0.001）。与对照组相比，没有证据表明TSM组有干预作用。与8个月的随访结果相比，在17个月的随访中大多数情况下，由外行辅导员提供的干预效果更大：学校气候（影响大小[ES; 95％CI] = 2.23 [1.97-2.50]对1.88 [ 1.44-2.32]，p <0.001）；抑郁（ES [95％CI] = -1.19 [-1.56至-0.82]与-0.27 [-0.44至-0.11]，p <0.001）；对性别平等的态度（ES [95％CI] = 0.53 [0.27-0.79]对0.23 [0.10-0.36]，p <0.001）；欺凌（ES [95％CI] = -2.22 [-2.84至-1.60]与-0.47 [-0.61至-0.33]，p <0.001）；暴力受害（OR [95％CI] = 0.08 [0.04-0.14]对0.62 [0.46-0.84]，p <0.001）；和暴力行为（OR [95％CI] = 0.16 [0.09-0.29]与0.68 [0.48-0.96]，p <0.001），表明在扩大干预措施后会增加收益。该研究的局限性在于27％的基线参与者未完成17个月的结果评估。结论该试验表明，第二年的结局与第一年的结局相似，没有由老师主导的干预的影响，并且由于延长了由非专业顾问提供的干预而对学校的气候和青少年健康产生了更大的好处。试验注册ClinicalTrials.gov NCT02907125。