Kauer Sylvia D, Buhagiar Kerrie, Blake Victoria, Cotton Sue, Sanci Lena
Department of General Practice, The University of Melbourne, Carlton, Australia.
ReachOut Australia, Sydney, Australia.
BMJ Open. 2017 Jul 9;7(7):e015303. doi: 10.1136/bmjopen-2016-015303.
To explore the feasibility of a dedicated online youth mental health help-seeking intervention and to evaluate using a randomised controlled trial (RCT) study design in order to identify any modifications needed before commencement of the full-scale RCT.
A pilot RCT with 1:1 randomisation to either the intervention or comparison arm.
An online study conducted Australia-wide.
18-25 year olds living in Australia were recruited via social media.
Link is a dedicated online mental health help-seeking navigation tool that matches user's mental health issues, severity and service-type preferences (online, phone and face-to-face) with appropriate youth-friendly services. The comparison arm was usual help-seeking strategies with a link to Google.com.
The primary outcome was the number of acceptability and feasibility criteria successfully met. Intervention and study design acceptability and feasibility were assessed by nine criteria. Secondary outcomes, via online surveys (at baseline, 1 week and 1 month) measured service use, help-seeking intentions, psychological distress, barriers to help-seeking, attitudes towards mental health help-seeking, mental health literacy, satisfaction and trust.
Fifty-one participants were randomised (intervention: n=24; comparison: n=27). Three out of four of the intervention and two out of five of the study design criteria were met. Unmet criteria could be addressed by modifications to the study design. Qualitative analysis demonstrated that Link was useful to participants and may have increased their positive experiences towards help-seeking. There were no observable differences between arms in any outcome measures and no harms were detected.
Generally, the Link intervention and study design were acceptable and feasible with modifications suggested for the four out of nine unmet criteria. The main trial will hence have shorter surveys and a simpler recruitment process, use positive affect as the primary outcome and will not link to Google.com for the comparison arm.
Australian New Zealand Clinical Trials Registry, ACTRN12614000386639.
探讨一项专门的在线青少年心理健康求助干预措施的可行性，并采用随机对照试验（RCT）研究设计进行评估，以便在全面开展RCT之前确定所需的任何修改。
一项试点RCT，按1:1随机分为干预组或对照组。
在全澳大利亚范围内进行的一项在线研究。
通过社交媒体招募居住在澳大利亚的18 - 25岁青年。
Link是一款专门的在线心理健康求助导航工具，可将用户的心理健康问题、严重程度和服务类型偏好（在线、电话和面对面）与合适的青少年友好型服务相匹配。对照组采用常规求助策略并提供谷歌网站链接。
主要结局是成功满足的可接受性和可行性标准的数量。通过九条标准评估干预措施和研究设计的可接受性和可行性。次要结局通过在线调查（基线、1周和1个月时）测量服务使用情况、求助意愿、心理困扰、求助障碍、对心理健康求助的态度、心理健康素养、满意度和信任度。
51名参与者被随机分组（干预组：n = 24；对照组：n = 27）。干预措施的四条标准中有三条、研究设计的五条标准中有两条得到满足。未满足的标准可通过修改研究设计来解决。定性分析表明，Link对参与者有用，可能增加了他们对求助的积极体验。在任何结局指标上两组之间均未观察到差异，也未发现有害影响。
总体而言，Link干预措施和研究设计是可接受且可行的，针对九条未满足标准中的四条提出了修改建议。因此，主要试验将采用更简短的调查问卷和更简单的招募流程，将积极情绪作为主要结局指标，并且对照组不再链接到谷歌网站。
澳大利亚新西兰临床试验注册中心，ACTRN12614000386639。
