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Randomised controlled trials (RCTs) are considered the bedrock of evidence‐based practice. However, they raise important issues about participant recruitment and the ethics of group allocation. In this article we report relevant literature on how participants with learning disabilities and other stakeholders experience RCTs. Five quantitative studies have been published, one reporting on the views of people with learning disabilities and the remainder on carers' views. Despite the methodological limitations of the studies, carers appear to have a positive experience of RCT participation, and people with learning disabilities are able to understand certain aspects of research methods. We conclude that stakeholders are not hostile to RCTs, but the therapeutic misconception may affect their experiences. Further research is required to investigate interventions that might help promote RCTs in learning disabilities.

Realism is emerging as a paradigm for research and explanation in the natural and social sciences. A realist framework is elaborated and applied to the four possible situations that may generate the observations of randomised, controlled trials. It is demonstrated that by using two realist concepts “mechanism” and “context” a number of misinterpretations of such trials from within the dominant empiricist paradigm may be rectified. Evidence based medicine should adopt realism to temper a misleading empiricism, this will involve relegating statistical arguments to their proper subsidiary place and adopting an adequate theory of causation.

The purpose of this paper is to describe and discuss both the early implementation of a US mental health intervention for young children in the context of its introduction to a pilot site in a London borough and the progress made in establishing a randomised controlled trial (RCT).

This paper describes an evaluation of a new intervention and the learning that followed in terms of its implementation and future evaluation. Qualitative data were collected from a range of stakeholders and practitioners through interviews and small group discussions. These interviews focussed on both of these issues, with particular reference to the proposal to conduct an RCT.

The findings of this evaluation add to the evidence on how best to support new initiatives that have been introduced from other settings and countries to embed in a receiving site and the optimal timing and feasibility of conducting an RCT. At the end of the feasibility study, which took place within the year of the service being introduced and which was only open to clients for six months of this year the conclusion was that an RCT at that point was neither possible nor desirable. Over the following years, the commitment of the judiciary to examine if there was a way to make an RCT study in respect of this intervention meant that a template was established that may well have broader application.

At a time when there is an increasing demand for evidence on effective interventions this paper makes a valuable contribution to the development of RCTs in general and specifically in the family court arena. It also recommends that attention must also be paid to the time, which is needed to implement and establish interventions and then to test them.

This paper highlights the need to establish realistic timescales not only around the implementation of initiatives but also for their evaluation.

This study breaks new ground in considering implementation challenges in the court and children’s services’ context. It brings to the fore the important role of the judiciary in approving new processes.

Randomised controlled trials (RCTs) have been offered a privileged position in terms of the evidence base for preventive interventions for children, but practical and theoretical issues challenge this research methodology. This paper aims to address this issue.

This paper analyses practical and methodological issues of using RCTs within children's preventive services and presents the results of a qualitative study using data collected from parents who were asked to take part in an RCT of a preventive intervention.

Well recognised issues include the impossibility of blinding participants, the problem of identifying a pre‐eminent outcome measure for complex interventions, and problems with limiting access to equivalent interventions in real world settings. A further theoretical problem is the exclusion from RCTs of families who are most ready to change, resulting in a reduced level of intervention effectiveness. Qualitative evidence from one recent RCT suggests that this problem could be operating in some prevention trials. Increasing sample sizes can overcome some of these problems, but the cost of the necessarily huge trials becomes disproportionate to the intervention?

Given the limitations on RCTs in preventive settings, the paper argues their privileged position in terms of research evidence maybe undeserved.

The randomised control trial is regarded as the gold standard among the methods used in treatment outcome studies, whatever the treatment. This method imposes the highest level of control over other factors that may influence outcome so that the true effects of the treatment can be tested. In this paper the key features of an RCT are examined, along with potential challenges that emerge when applied to evaluations of psychotherapeutic interventions with people who have learning disabilities.

The World Health Organization Suicide trends in at-risk territories study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU) or TAU plus Brief Intervention and Contact (BIC), which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless – given its importance – the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country.

The need for randomised controlled trials (RCTs) to support evidence‐based services to improve outcomes for children is increasingly recognised by researchers and policy‐makers. However, this brings a pressing requirement to build research capacity for conducting RCTs and to address the concerns of practitioners who may be suspicious about the method. This article reviews a variety of texts on the subject, ranging from analyses of the historical and political context of RCTs, to concise introductions of the key methodological and practical issues, to more in‐depth discussions of complex designs and statistics. The article seeks to help readers navigate these resources by focusing on seven questions that seem particularly salient for those considering whether and how to commission, undertake, participate in or use results from RCTs.

The purpose of this paper is to evaluate the effectiveness of a free book gifting programme, called “Bookstart+”, in improving family reading outcomes.

Bookstart+ consists of a pack of books and reading materials provided to families at their two-year-old child's statutory health visit. The pack is accompanied by a short priming demonstration, delivered by the health visitor, on shared reading. The evaluation took the form of a randomised controlled trial (RCT) with 460 families from the client lists of 115 health visitors.

The study found evidence of: a positive significant effect on parents’ attitudes to reading and books (Cohen's d=+0.192, p=0.034); no significant effect on parental attitudes to their child reading (d=+0.085, p=0.279); and a negative effect, approaching significance, on public library usage (d=−0.160, p=0.055).

The attrition rate was high, with only 43.9 per cent of the target families completing all of the research. However, this level of attrition did not lead to any significant differences between the control and intervention groups on their pre-test measures.

The study provides recommendations for free book gifting service provision in relation to pack contents and delivery.

This paper contributes to the limited international RCT evidence on free book gifting programmes.

The purpose of this paper is to focus upon the challenges faced by a research team when conducting a computerised cognitive behaviour therapy (CCBT) trial for adolescents with low mood/depression and how solutions were sought to eliminate these difficulties in future child and adolescent mental health clinical research.

The authors have presented a number of problems faced by the research team when conducting a randomised controlled trial (RCT) concerning adolescents with low mood/depression.

From examining the problems faced by the research team, the authors have provided key pieces of advice for prospective adolescent mental health RCTs. This advice includes developing clear project plans, setting strategies to encourage and maintain study information in the community and support recruitment, and keeping your organisation appraised of study needs and network and involve governance departments, IT and finance departments in these discussions early.

RCTs, particularly those focusing on child and adolescent mental health, can face a number of difficulties throughout its stages of completion (from protocol development to follow-up analysis). Studies involving the use of technologies add a layer of complexity to this. This review will be of value to researchers aiming to run a high-quality RCT concerning child and adolescent mental health.