by Michelle Janas
On offer from the Department for Education (DfE) is a portion of £15million to evaluate the use of family group conferences (FGCs) at the pre-proceedings stage in child protection cases via a randomised control trial (RCT). As a former medical researcher now training to be a social worker, the decision to use an RCT particularly caught my attention.
Until two years ago I was the principal scientist at a multinational biotechnology company that develops and trials the latest cell therapies for hard-to-treat cancers. So, while not a clinical trial expert, I feel somewhat equipped to write about the practicalities and ethics of RCTs, whether they pertain to medicine or social care.
RCTs are an attractive concept for researchers because of their ‘gold-standard’ status for generating empirical evidence. But ethically RCTs are contentious, because by their nature they test a group that has received a treatment or intervention against one for whom it has been deliberately denied. As such, RCTs should be used only under certain circumstances, with rules and checks in place that ensure they are conducted efficaciously.
Family group conferences’ benefits are known
The first premise for conducting an RCT is that there is a professional equipoise – that is, that there is genuine uncertainty about whether a treatment or intervention is beneficial. RCTs are useful when there is a stalemate in the field and they begin with a null hypothesis, in other words the assumption that there will be no difference between the two groups.
With regard to FGCs though, there is already a wealth of research demonstrating their benefit within the context of child safeguarding. In addition, a 2017 DfE report on the use of Daybreak family group conferencing for children on the edge of care conclusively showed an increased proportion of children remaining with their families when FGCs were used.
Interestingly, Daybreak, a charity specialising in providing FGCs, is the identified partner for conducting the proposed RCT – yet the 2017 study recommendations make no mention of such an approach. Rather, they call for an extended follow-up period and strategies for integrating FGCs into local authorities.
There are detractors, perhaps most notably a meta-analysis of 14 non-UK studies which showed no significant reduction in out-of-home placements when FGCs were used. But its relevance to FGC use in the UK has rightly been critiqued by David Wilkins, who pointed out that the spirit in which FCGs are conducted, and the way in which outcomes are measured, will influence any evaluation.
With reference to RCTs specifically, the results of a large US study by Tyler Corwin and others on the effectiveness of FGCs in active child protection cases have just been published. They add to the strong favourable discourse for including FGCs at the pre-proceedings stage. Thus, questions must be asked as to what added value this newly proposed RCT will bring, and whether the What Works Centre is merely repeating and confirming published evidence rather than conducting genuinely novel research.
The ethics of consent and non-treatment controls
RCTs that have a non-treatment (or placebo) group, as for the FCG proposal, bring up a unique ethical dilemma. As with any research study, the explicit consent of all participants is paramount, and thus those families allocated to the control group will (presumably) be aware that they are being denied an FGC.
Although it may be tempting to conceal the existence of the trial to these families, their resulting data cannot be published without their explicit consent (and could otherwise be challenged lawfully). Presumably the What Works Centre’s research partner CASCADE and its approving ethics committee at Cardiff University understand this.
Aside from this practicality, there is something unpalatable about the active withholding of a support option at a time when a family is at risk of losing their child(ren). In the US study mentioned above, the control group was offered a family team meeting instead of an FGC, but they were also able to override the study protocol and ask for an FGC.
A similar issue of contention arises in medicine. For example, when conducting surgical RCTs a placebo group is considered tolerable if the risks are minimal and when the procedure offers some benefit (such as a diagnosis).
However, in cancer therapy, where the stakes are high, RCTs will never include a placebo group where the potential for a life-saving treatment is available. Indeed, a notable 2016 study forcefully asserts that participants can only be assigned to a placebo if they “are not substantially more likely than those in active treatment group(s) to die; suffer irreversible morbidity, disability, or other substantial harms; suffer reversible but serious harm; or suffer severe discomfort”.
One could argue that the removal of a child to state care also risks serious harm, for both the child, parent(s), and extended family.
Randomisation and blinding
The essence of RCTs is that they are designed to minimise bias. This is achieved by randomly assigning individuals to groups (as the name suggests) and by a process of blinding.
This is important because, as has been shown in medical trials, a lack of concealment at the time of allocation and/or assessment is known to produce an outcome bias in favour of the intervention. A trial can be single-blind (the participants do not know which group they have been assigned to) or double-blind (neither the participants nor researchers are aware of the allocation).
In the proposed RCT for FGCs, blinding is not practically possible. Although a researcher in an office might randomly assign the families to cohorts, the families will obviously know which group they are in, as will the professionals assessing them. Indeed, this was one of the major limitations of the Corwin study, and arguably negated its objectivity and status as an RCT.
Reporting for an FGC trial will always be subjective, unless one is crudely measuring whether a child remains in their family’s care or not. Even then accidental bias needs to be considered, as the mere act of offering a family an FGC may render them more hopeful, responsive and engaged than those for whom an FGC has been denied (who might in turn become increasingly despondent, especially in the face of pre-proceedings).
RCTs are time and resource intensive
While RCTs might be considered the ultimate in data generation, they are time and resource heavy. The What Works Centre cites a two-year evaluation period for its proposal, yet the protocol and evaluation plan have yet to be published.
For comparison, the study design (including ethics) for the Corwin RCT was approved in 2012, and the results published seven years later. One of the recommendations from the 2017 Daybreak report, which also had a two-year runtime, was for a longer-term follow-up on families, which would be impossible to implement within another two-year restriction.
Further consideration must also be given to the number of families that would need to be recruited for an RCT. The Corwin RCT accepted 544 families onto the study, but only 287 (53%) were included in the final analysis. This was in part due to families in the control group exercising their right to an FGC, thereby excluding themselves from the trial.
While the resulting data was statistically significant (in favour of the inclusion of FGCs), the study limitations, including the inability to conduct a blinded trial and ensure objectivity, led to an authors’ statement that “these results should be interpreted with caution”. Surely the WWC does not seek to do the same.
With that in mind, perhaps it is better to design a trial that is appropriate for the practical and ethical realities of family group conferences and ensure success, rather than retrofitting into an RCT and producing another study full of caveats (a conclusion others have also reached).
A randomised control trial will never improve research rigour if the ethics are compromised and the design is flawed. There are many alternative options that the FGC portion of the £15 million DfE money could support, and I am confident the What Works Centre, academic community and family-advocate groups could work together to design a study that is robust and beneficial for all.
Michelle Janas graduated with a PhD in medicine in 2000 and is currently studying for a social work master’s at Oxford Brookes University.