The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study

Abstract

BackgroundThis descriptive study aimed to investigate adolescents’ motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspects of the trial design, to examine whether or not they found participation in the trial to be acceptable and what affected this, and to identify whether and how the young people felt that their participation in the RCT impacted on their experience of therapy and on therapeutic change.MethodsSeventy-six adolescents who were taking part in a large-scale RCT to evaluate the clinical and cost effectiveness of psychological therapies for depression were interviewed at two time-points after completing therapy. The semi-structured interviews, which included a focus on the young people’s experience of the research study, were analysed using framework analysis.ResultsThe vast majority of adolescents found it acceptable to participate in the clinical trial, and many agreed to participate for reasons of ‘conditional altruism’. However consent was often given without great understanding of the key elements of the trial, including the difference between treatment arms and the randomisation process. Although the adolescents were largely positive about their experiences from taking part, the study raises questions about whether clinical outcomes may be influenced by participation in the research elements of the trial.ConclusionsAlthough adolescents are under-represented in clinical trials, those who do participate are generally positive about the experience; however, careful thought needs to be given to key elements of the trial design and the potential impact of the research participation on clinical outcomes.Trial registrationISRCTN registry, ISRCTN83033550. Registered on 15 October 2009.

Carers’ Motivations for, and Experiences of, Participating in Suicide Research

“…For example, in a study examining the ethics of general bereavement research, the authors found that bereaved adults felt positive about bereavement research, reporting perceived benefits in line with altruistic motivations [34]. Treatment focused research also suggests that some people are motivated by the hope that research participation will benefit them in personal, direct ways, such as access to treatments [32], a phenomenon termed "conditional altruism" [35].…”

Children and young people’s experiences of completing mental health and wellbeing measures for research: learning from two school-based pilot projects

“…At present, there is relevant literature relating to the experience of CYP research participation more generally [38,39], as well as school-based research engagement [31][32][33][34][35] and mental health measure completion for clinical purposes [40]. However, to our knowledge, there is no prior research exploring CYP's experiences of completing mental health and wellbeing measures for school-based research (though a recent study explored school-based completion of self-harm measures [41]).…”

20/20 Hindsight: A 25-year programme at the Anna Freud Centre of efficacy and effectiveness research on child psychoanalytic psychotherapy

“…Giving the participants a voice on these central subjects, allowing them to provide their own interpretations of their own experiences and "results" may, as we join the quantitative and qualitative findings together across individuals , give us the strongest handle on what can lead to positive change, and sticking with treatment, or may on the other hand leave the young person still facing what might be a life sentence of disabling depression. So far, papers have addressed the following topics from interviews: the experience of depression (Midgley et al, 2015); where depression has come from ; experience of treatment (Midgley, Holmes, et al, 2016); experience of participating in an RCT (Midgley, Isaacs, Weitkamp, & Target, 2016); and experience of being a parent of a depressed adolescent . Many further questions are to be explored from the very large set of often rich interviews.…”