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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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968559 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-244X (Electronic) Linking ISSN: 1471244X NLM ISO Abbreviation: BMC Psychiatry Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
    • 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.
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    • Grant Information:
      15/162/02 United Kingdom DH_ Department of Health; MCCC-FCO-11-U United Kingdom MCCC_ Marie Curie; 15/162/02 International Health Technology Assessment Programme
    • Contributed Indexing:
      Keywords: Challenging behaviour; Intellectual disabilities; Parenting interventions; Randomised control trial; SSTP; Stepping stones triple P
    • Molecular Sequence:
      ClinicalTrials.gov NCT03086876
    • Publication Date:
      Date Created: 20200201 Date Completed: 20201109 Latest Revision: 20210120
    • Publication Date:
      20240105
    • Accession Number:
      PMC6993328
    • Accession Number:
      10.1186/s12888-020-2451-6
    • Accession Number:
      32000729