EPICC-ID Randomised Controlled Trial

  • Research type

    Research Study

  • Full title

    Clinical and cost effectiveness of a parent mediated intervention to reduce challenging behaviour in pre-schoolers with moderate to severe learning disability: a randomised controlled trial

  • IRAS ID

    223015

  • Contact name

    Angela Hassiotis

  • Contact email

    a.hassiotis@ucl.ac.uk

  • Sponsor organisation

    University College London Hospitals

  • Clinicaltrials.gov Identifier

    NCT03086876

  • Clinicaltrials.gov Identifier

    Z6364106/2017/03/46 , Data Protection Registration Number

  • Duration of Study in the UK

    3 years, 11 months, 31 days

  • Research summary

    Summary of Research

    Children with intellectual Disabilities are one of the most under-served groups in society, facing well documented health inequalities and at four times the risk of developing a mental disorder compared to neuro-typical children. Reports indicate that challenging behaviour, e.g. temper tantrums, aggression occurs in as many as 40,000 young people under 18 years living in England. There is significant research evidence from the general population that parenting groups can be helpful. These programmes, if offered early, may reduce and even prevent serious emotional problems from developing in the child, later in life. Cost benefits are associated with improved health and social outcomes in the young person. The National Institute of Health and Care Excellence (NICE) guideline on behaviour that challenges reviewed all the available evidence and found very few programmes specifically developed for children and young people with ID and challenging behaviour; it recommended further research to address the lack of such interventions.
    In this study, we propose to evaluate level 4 Stepping Stones Triple P (SSTP)
    delivered by trained practitioners to groups of parents of young children aged 30-59 months with moderate to severe LD. The programme lasts for 9 weeks and has shown positive results in small trials outside the UK. However, it needs to be tested within the UK health system before it is rolled out. We shall examine whether SSTP reduces challenging behaviour at four and 12 months after randomisation. We shall ask about the child's and the parent's health related quality of life, difficulties with care, parent stress, service use and how the parent has found the intervention.
    We shall interview the service managers and the therapists about their experience of hosting and delivering the intervention. We shall recruit parents to the Parent Advisory Group to advise about various aspects of the study, e.g. materials, interview topic guides, dissemination.

    Summary of Results

    Research shows that in children without intellectual disabilities, parenting groups which support parents in developing skills to manage such behaviours in their child can be helpful. The National Institute of Health and Care Excellence recommended that more research was needed to strengthen the evidence for such interventions for children with moderate to severe intellectual disability who are more likely to display behaviours that challenge in England. In this study, we tested in real-world conditions a programme called level 4 Stepping Stones Triple P which showed positive results in trials outside the UK. Trained therapists delivered 6 groups and 3 individual sessions over 9 weeks to parents of children aged 30-59 months with moderate to severe intellectual disability. Two hundred and sixty-one parents were allocated to one of two arms by chance (randomisation): one received Stepping Stones Triple P and treatment as usual and the other treatment as usual only. Treatment as usual included support and advice by GPs or community child development teams. Our primary outcome was parent-reported child behaviour at 12 months after randomisation. We also collected data on other outcomes and carried out interviews with parents, service managers and therapists to find out their views about Stepping Stones Triple P. We did not find that Stepping Stones Triple P reduces the child’s behaviour more than treatment as usual at 12 months. However, when we examined the group who received more than half of the sessions, it showed a larger reduction in such behaviours which suggests that Stepping Stones Triple P works for families if they attend the full programme. Stepping Stones Triple P is fairly cheap to deliver and a suitable option for early intervention for behaviours that challenge especially as parents are positive about it. Throughout the trial, we included a Parent Advisory Group who oversaw study materials, interview topic guides, and promotion of the study.

  • REC name

    London - Camden & Kings Cross Research Ethics Committee

  • REC reference

    17/LO/0659

  • Date of REC Opinion

    19 May 2017

  • REC opinion

    Further Information Favourable Opinion