Randomized Controlled Trial

. 2020 Jan 30;20(1):35.

doi: 10.1186/s12888-020-2451-6.

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 Farris¹, Rachel Royston², Michael Absoud³, Gareth Ambler⁴, Jacqueline Barnes⁵, Rachael Hunter⁶, Marinos Kyriakopoulos⁷, Kate Oulton⁸, Eleni Paliokosta⁹, Monica Panca⁶, Laura Paulauskaite¹, Michaela Poppe¹, Federico Ricciardi⁴, Aditya Sharma¹⁰, Vicky Slonims³, Una Summerson¹¹, Alastair Sutcliffe¹², Megan Thomas¹³, Angela Hassiotis¹

Affiliations

¹ Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.
² Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. r.royston@ucl.ac.uk.
³ Evelina London Children's Hospital, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH and King's College London, Strand, London, WC2R 2LS, UK.
⁴ Department of Statistical Science, University College London, Gower Street, London, WC1E 6BT, UK.
⁵ Department of Psychological Sciences, Birbeck University of London, Malet Street, London, WC1E 7HX, UK.
⁶ Research Department of Primary Care and Population Health, Royal Free Medical School, NW3 2PF, London, UK.
⁷ South London and Maudsley NHS Foundation Trust and Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO66 De Crespigny Park, London, SE5 8AF, UK.
⁸ Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, WC1N 3JH, UK.
⁹ The Effra Clinic, 4th Floor, 86-90 Paul Street, London, EC2A 4NE, UK.
¹⁰ Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.
¹¹ , Contact, 209-211 City Road, EC1V 1JN, London, UK.
¹² Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
¹³ Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool Victoria Hospital, Whinney Heys Road, Blackpool, FY3 8NR, UK.

PMID: 32000729
PMCID: PMC6993328
DOI: 10.1186/s12888-020-2451-6

Randomized Controlled Trial

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 et al. BMC Psychiatry. 2020.

. 2020 Jan 30;20(1):35.

doi: 10.1186/s12888-020-2451-6.

Authors

Affiliations

¹ Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.
² Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK. r.royston@ucl.ac.uk.
³ Evelina London Children's Hospital, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH and King's College London, Strand, London, WC2R 2LS, UK.
⁴ Department of Statistical Science, University College London, Gower Street, London, WC1E 6BT, UK.
⁵ Department of Psychological Sciences, Birbeck University of London, Malet Street, London, WC1E 7HX, UK.
⁶ Research Department of Primary Care and Population Health, Royal Free Medical School, NW3 2PF, London, UK.
⁷ South London and Maudsley NHS Foundation Trust and Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, PO66 De Crespigny Park, London, SE5 8AF, UK.
⁸ Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London, WC1N 3JH, UK.
⁹ The Effra Clinic, 4th Floor, 86-90 Paul Street, London, EC2A 4NE, UK.
¹⁰ Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, NE1 7RU, UK.
¹¹ , Contact, 209-211 City Road, EC1V 1JN, London, UK.
¹² Institute of Child Health, 30 Guilford Street, London, WC1N 1EH, UK.
¹³ Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool Victoria Hospital, Whinney Heys Road, Blackpool, FY3 8NR, UK.

PMID: 32000729
PMCID: PMC6993328
DOI: 10.1186/s12888-020-2451-6

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://clinicaltrials.gov/ct2/show/NCT03086876.

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

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Conflict of interest statement

The authors declare they have no competing interests.

Figures

**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

See this image and copyright information in PMC

References

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1. Emerson E, Hastings RP, McGill P, Pinney A, Shurlock J. Estimating the number of children in England with learning disabilities and whose behaviours challenge; 2014.
1. Emerson E, Bromley J. The form and function of challenging behaviours. J Intellect Disabil Res. 1995;39(5):388–398. doi: 10.1111/j.1365-2788.1995.tb00543.x. - DOI - PubMed
1. Absoud M, Wake H, Ziriat M, Hassiotis A. Managing challenging behaviour in children with possible learning disability. BMJ. 2019;365:l1663. doi: 10.1136/bmj.l1663. - DOI - PubMed
1. Einfeld SL, Piccinin AM, Mackinnon A, Hofer SM, Taffe J, Gray KM, Bontempo DE, Hoffman LR, Parmenter T, Tonge BJ. Psychopathology in young people with intellectual disability. JAMA. 2006;296(16):1981–1989. doi: 10.1001/jama.296.16.1981. - DOI - PMC - PubMed

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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

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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

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