Robotham, D.J.; (2010) Participant opinions of randomised controlled trials within intellectual disability services. Doctoral thesis , UCL (University College London).

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Abstract

OBJECTIVE: This study examined participants’ opinions and beliefs about Randomised Controlled Trials (RCTs) in an intellectual disability context. BACKGROUND: RCTs in this field require co-operation from various stakeholders, including carers and professionals from a variety of disciplines. However, previous research indicates that local stakeholders may have negative views regarding RCTs in this population, and that it may be difficult for researchers to gain access to participants. This is compounded by the potential problems surrounding communication with a proportion of the service users. METHOD: The present study builds upon an RCT for a behaviour therapy intervention for people with intellectual disability, which was situated within community based services in one county of South East England. Fifty-one individuals were interviewed; 11 paid carers, 7 family carers, 6 adults with mild intellectual disability, and 27 professionals from health and social care services. The interviews elicited opinions, beliefs and decision-making processes relating to stakeholder experiences of the RCT. Data was analysed through coding emergent categories into a framework, which evolved throughout the analysis. RESULTS: The data revealed that opinions about RCTs were shaped by several concerns. The most important of these included the following; continued ability to access interventions, the ethical concerns surrounding randomisation, perceptions of limited financial resources, and problems involving communication and consent. DISCUSSION: RCTs are ubiquitous in clinical research, including psychiatry. However, they present difficulties for researchers and participants in the field of intellectual disability. Good communication with all stakeholders is essential to ensure the successful conduct of an RCT. This study provides information for academics and clinicians who plan to conduct future research and RCTs with people who have intellectual disability. The findings may be used in future to develop appropriate strategies to assist with recruitment for RCTs in intellectual disability, and to increase stakeholders’ acceptance of the procedure.

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