The George Institute for Global Health, New Delhi, India.
All India Institute of Medical Sciences, New Delhi, India.
Trials. 2022 Jul 29;23(1):612. doi: 10.1186/s13063-022-06539-8.
There are around 250 million adolescents in India. Adolescents are vulnerable to common mental disorders with depression and self-harm accounting for a major share of the burden of death and disability in this age group. Around 20% of children and adolescents are diagnosed with/ or live with a disabling mental illness. A national survey has found that suicide is the third leading cause of death among adolescents in India. The authors hypothesise that an intervention involving an anti-stigma campaign co-created by adolescents themselves, and a mobile technology-based electronic decision support system will help reduce stigma, depression, and suicide risk and improve mental health for high-risk adolescents living in urban slums in India.
The intervention will be implemented as a cluster randomised control trial in 30 slum clusters in each of the cities of Vijayawada and New Delhi in India. Adolescents aged 10 to 19 years will be screened for depression and suicide ideation using the Patient Health Questionnaire (PHQ-9). Two evaluation cohorts will be derived-a high-risk cohort with an elevated PHQ-9 score ≥ 10 and/or a positive response (score ≥ 2) to the suicide risk question on the PHQ-9, and a non-high-risk cohort comprising an equal number of adolescents not at elevated risk based on these scores.
The key elements that ARTEMIS will focus on are increasing awareness among adolescents and the slum community on these mental health conditions as well as strengthening the skills of existing primary healthcare workers and promoting task sharing. The findings from this study will provide evidence to governments about strategies with potential for addressing the gaps in providing care for adolescents living in urban slums and experiencing depression, other significant emotional or medically unexplained complaints or increased suicide risk/self-harm and should have relevance not only for India but also for other low- and middle-income countries.
Protocol version - V7, 20 Dec 2021 Recruitment start date: tentatively after 15th July 2022 Recruitment end date: tentatively 14th July 2023 (1 year after the trial start date) TRIAL REGISTRATION: The trial has been registered in the Clinical Trial Registry India, which is included in the WHO list of Registries ( https://www.who.int/clinical-trials-registry-platform/network/primary-registries ) Reference No. CTRI/2022/02/040307 . Registered on 18 February 2022. The tentative start date of participant recruitment for the trial will begin after 15th July 2022.
印度约有 2.5 亿青少年。青少年易患常见精神障碍，其中抑郁症和自残占该年龄段死亡和残疾负担的很大一部分。约 20%的儿童和青少年被诊断患有/或患有致残性精神疾病。一项全国性调查发现，自杀是印度青少年的第三大死因。作者假设，一项涉及由青少年自己共同创作的反污名运动和基于移动技术的电子决策支持系统的干预措施，将有助于减少污名、抑郁和自杀风险，并改善印度城市贫民窟中高风险青少年的心理健康。
该干预措施将在印度维杰亚瓦达和新德里市的每个城市的 30 个贫民窟集群中以集群随机对照试验的形式实施。使用患者健康问卷（PHQ-9）对 10 至 19 岁的青少年进行抑郁和自杀意念筛查。将衍生出两个评估队列-一个高风险队列，其 PHQ-9 得分≥10，或 PHQ-9 上的自杀风险问题的阳性反应（得分≥2）；另一个非高风险队列，由根据这些分数确定的数量相等的没有高风险的青少年组成。
ARTEMIS 将重点关注的关键要素是提高青少年和贫民窟社区对这些心理健康状况的认识，以及加强现有初级保健工作者的技能和促进任务分担。这项研究的结果将为政府提供有关战略的证据，这些战略有可能解决为生活在城市贫民窟中、经历抑郁、其他重大情绪或医学上无法解释的投诉或自杀风险/自残增加的青少年提供护理方面的差距，并且不仅对印度，而且对其他中低收入国家也具有相关性。
方案版本-V7，2021 年 12 月 20 日。招募开始日期：暂定在 2022 年 7 月 15 日之后。招募结束日期：暂定在 2023 年 7 月 14 日（试验开始日期后 1 年）。试验已在印度临床试验注册处注册，该注册处被列入世界卫生组织登记处名单（https://www.who.int/clinical-trials-registry-platform/network/primary-registries）参考号 CTRI/2022/02/040307。2022 年 2 月 18 日注册。该试验的参与者招募暂定在 2022 年 7 月 15 日之后开始。
