Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe intellectual disability (EPICC-ID) study protocol: a multi-centre, parallel-group randomised controlled trial

Olayinka Farris, Rachel Royston, Michael Absoud, Gareth Ambler, Jacqueline Barnes, Rachael Hunter, Marinos Kyriakopoulos, Kate Oulton, Eleni Paliokosta, Monica Panca, Laura Paulauskaite, Michaela Poppe, Federico Ricciardi, Aditya Sharma, Vicky Slonims, Una Summerson, Alastair Sutcliffe, Megan Thomas, Angela Hassiotis, Olayinka Farris, Rachel Royston, Michael Absoud, Gareth Ambler, Jacqueline Barnes, Rachael Hunter, Marinos Kyriakopoulos, Kate Oulton, Eleni Paliokosta, Monica Panca, Laura Paulauskaite, Michaela Poppe, Federico Ricciardi, Aditya Sharma, Vicky Slonims, Una Summerson, Alastair Sutcliffe, Megan Thomas, Angela Hassiotis

Abstract

Background: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.

Methods: This trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual, whilst the Treatment as Usual only group receive other available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data will also be collected to carry out a cost effectiveness and utility evaluation.

Discussion: Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.

Trial registration number: Clinicaltrials.gov, NCT03086876. Registered 22nd March 2017, https://ichgcp.net/clinical-trials-registry/NCT03086876.

Keywords: Challenging behaviour; Intellectual disabilities; Parenting interventions; Randomised control trial; SSTP; Stepping stones triple P.

Conflict of interest statement

The authors declare they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study design. This chart demonstrates the flow of participants through the trial from initial contact to the completion of the follow-up assessments

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