Parents' understanding and motivation to take part in a randomized controlled trial in the field of adolescent mental health: a qualitative study.

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.

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

BACKGROUND: This 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. METHODS: Seventy-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. RESULTS: The 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. CONCLUSIONS: Although 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 REGISTRATION: ISRCTN registry, ISRCTN83033550 . Registered on 15 October 2009.