Parents\u2019 understanding and motivation to take part in a randomized controlled trial in the field of adolescent mental health: a qualitative study

Sally O’Keeffe,Mary Target,Nick Midgley,Danny Isaacs,Virginia Eatough,Katharina Weitkamp

doi:10.1186/s13063-020-04857-3

Abstract

BackgroundLittle 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.MethodsSixty-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.ResultsFor 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.ConclusionsThis 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 registrationISRCTN registry ISRCTN83033550. Registered on 15 October 2009

Highlights

Little is known about why parents agree to take part in randomized controlled trials for adolescent mental health
Setting for the study This study involved secondary data analysis of interviews carried out as part of a larger longitudinal, qualitative study examining the experiences of a group of young people, their parents and therapists who were taking part in a randomized clinical trial investigating the treatment of adolescent depression
The parents in this study were in one of three treatment arms, the focus of this study is on their experience of the Randomized controlled trial (RCT) rather than of treatment itself

Summary

Introduction

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. Randomized controlled trials (RCTs) are considered the ‘gold standard’ when it comes to evaluating the effectiveness of treatments. Such studies rely upon participation from service users, and in recent years, there has been growing emphasis on the inclusion of service users both in the design of such studies [1], and in order to better understand the barriers and facilitators to study participation [2, 3]. The inclusion of parents in such studies is necessary as parents will often have a key role in psychological therapies for their children and in some cases may be actively involved in the sessions themselves [7] or maybe offered individual sessions alongside their child’s treatment [8]

Methods

Results

Conclusion