家长参与青少年心理健康领域随机对照试验的理解和动机：一项定性研究。
Parents' understanding and motivation to take part in a randomized controlled trial in the field of adolescent mental health: a qualitative study.
机构信息
Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, 4-8 Rodney Street, London, N1 9JH, UK.
School of Health Sciences, City, University of London, London, UK.
出版信息
Trials. 2020 Nov 23;21(1):952. doi: 10.1186/s13063-020-04857-3.
BACKGROUND
Little is known about why parents agree to take part in randomized controlled trials for adolescent mental health. This study aimed to investigate parents' perspectives on participating in a trial for psychological treatment of depression. The study explored parents' motivations, understanding of the trial and perspectives on the acceptability of the trial.
METHODS
Sixty-five parents took part in this qualitative study. Their adolescent children had been randomly allocated to one of three active psychological treatments for depression as part of the IMPACT trial and were interviewed about their experiences of participating in the study. Semi-structured interviews were analysed using framework analysis.
RESULTS
For seven of the sixty-five parents, their experience of taking part in the trial was not covered in their interview so they were excluded from the analysis. The analysis was therefore based on the data from the parents of 58 adolescents taking part in the trial. The most commonly cited motivation for taking part in the study reported by parents was a desire to help others going through similar difficulties. Parents generally reported finding trial participation acceptable, although there were aspects that some reported finding less acceptable, including randomization and the burden of research assessments. Others spoke positively about the experience of trial participation and found it enjoyable or even therapeutic. Importantly, some did not appear to have a good understanding of the trial design, including randomization and treatment allocation.
CONCLUSIONS
This study indicates that trial participation can be a positive experience for parents, yet it raises concerns about how trialists can ensure that consent is fully informed, given that some parents appeared to have a poor understanding of the trial. Future studies should seek to explore how communication with trial participants can be improved, to ensure that trial participation is fully informed. Patient and public involvement will be crucial in ensuring this communication is accessible to stakeholders.
TRIAL REGISTRATION
ISRCTN registry ISRCTN83033550 . Registered on 15 October 2009.
背景
对于父母为何同意参与青少年心理健康的随机对照试验，知之甚少。本研究旨在调查父母对参与抑郁心理治疗试验的看法。该研究探讨了父母的参与动机、对试验的理解以及对试验可接受性的看法。
方法
65 位家长参与了这项定性研究。他们的青少年子女已被随机分配到 IMPACT 试验中的三种积极心理治疗之一中，他们接受了关于参与研究的经验的半结构化访谈。使用框架分析对访谈进行了分析。
结果
在 65 位家长中，有 7 位家长的参与试验经历未在访谈中涉及，因此他们被排除在分析之外。因此，分析的依据是参与试验的 58 位青少年家长的数据。父母参与研究的最常见动机是帮助其他经历类似困难的人。父母普遍报告说，他们发现试验参与是可以接受的，尽管有些方面他们觉得不太能接受，包括随机化和研究评估的负担。其他人则对试验参与的经历评价很高，认为这是愉快的，甚至是有治疗作用的。重要的是，有些家长似乎对试验设计，包括随机化和治疗分配，没有很好的理解。
结论
本研究表明，试验参与对父母来说可能是一种积极的体验，但也引发了人们对试验人员如何确保知情同意的关注，因为有些家长似乎对试验设计理解不够。未来的研究应探讨如何改进与试验参与者的沟通，以确保试验参与是充分知情的。患者和公众的参与将是确保这种沟通对利益相关者具有可及性的关键。
试验注册
ISRCTN 注册处 ISRCTN83033550。于 2009 年 10 月 15 日注册。
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