Sorsdahl K, van der Westhuizen C, Neuman M, Weiss H A, Myers B
Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry & Mental Health, University of Cape Town, Cape Town, South Africa.
MRC Tropical Epidemiology Group, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, England.
Pilot Feasibility Stud. 2021 Mar 16;7(1):69. doi: 10.1186/s40814-021-00803-5.
Like many low- and middle-income countries, almost half of the proportion of the South African population is under the age of 25. Given the peak age of onset for most mental health problems is in adolescence, it is vital that adolescents have access to mental health counselling. There are several initiatives to increase access to mental health counselling in South Africa, primarily through the integration of counselling for common mental disorders (CMD) into primary health care services, but adolescents (15-18 years of age) generally do not utilize these services. To address this gap, we will undertake a study to explore the feasibility of conducting a trial of the effectiveness of a community-based mental health counselling intervention for adolescents at-risk for a CMD.
The study is a feasibility trial of the ASPIRE intervention, a four-session blended multi-component counselling intervention adapted for South African adolescents at risk for depression and alcohol use disorders. We will enrol 100 adolescents from community settings and randomly assign them to the ASPIRE intervention or a comparison condition. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, will be calculated. Qualitative interviews with participants and counsellors will explore the acceptability of the intervention. The primary outcomes for a subsequent trial would be reductions in symptoms of depression and days of heavy drinking which will be measured at baseline, 6 weeks, and 3 months post-randomization.
This feasibility trial using a mixed-methods design will allow us to determine whether we can move forward to a larger effectiveness trial of the ASPIRE intervention.
The trial is registered with the Pan African Clinical Trials Registry (PACTR20200352214510). Registered 28 February 2020-retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9795.
与许多低收入和中等收入国家一样，南非近一半人口年龄在25岁以下。鉴于大多数心理健康问题的发病高峰年龄在青春期，青少年能够获得心理健康咨询服务至关重要。南非有多项举措来增加心理健康咨询服务的可及性，主要是通过将常见精神障碍（CMD）咨询纳入初级卫生保健服务，但青少年（15 - 18岁）通常不使用这些服务。为了填补这一空白，我们将开展一项研究，以探索对有患CMD风险的青少年进行基于社区的心理健康咨询干预效果试验的可行性。
该研究是对ASPIRE干预的可行性试验，这是一种针对有抑郁和酒精使用障碍风险的南非青少年的四节混合多成分咨询干预。我们将从社区环境中招募100名青少年，并将他们随机分配到ASPIRE干预组或对照条件组。将计算诸如招募率、同意参与试验率和保留率等可行性指标。对参与者和咨询师进行定性访谈，以探讨干预措施的可接受性。后续试验的主要结局将是抑郁症状的减轻和重度饮酒天数的减少，这些将在随机分组后的基线、6周和3个月时进行测量。
这项采用混合方法设计的可行性试验将使我们能够确定是否可以推进对ASPIRE干预进行更大规模的效果试验。
该试验已在泛非临床试验注册中心（PACTR20200352214510）注册。于2020年2月28日注册——追溯注册，https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9795。
