Evaluation of Parent Intervention for Challenging Behaviour in Children With Intellectual Disabilities (EPICC-ID)
Condition: Challenging Behaviour
Study type: Interventional

Summary: 
      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.The 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 (TAU)
      whilst the TAU group receive 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 is also being collected to carry out a cost effectiveness and utility
      evaluation. Findings from this study will inform policy regarding interventions for
      challenging behaviour in young children with moderate to severe intellectual disabilities.
    

Detailed description: 
      About 1-2% of the population have a Learning disability (LD). This is a lifelong condition
      characterised by an intelligence quotient (IQ) of less than 70, general developmental delay
      and limitations in day to day activities. Children and adults with LD are some of the most
      under-served groups in society, with well documented health disparities and at four times the
      risk of developing a mental disorder. Reports indicate that challenging behaviour, e.g.
      temper tantrums, aggression or self injury, occurs in as many as 40,000 young people under 18
      years living in England. There is a significant evidence from research in the general
      population that parenting groups which support parents in developing skills to manage such
      behaviours in their child can be helpful. These programmes, if offered to parents early on,
      may reduce and even prevent serious emotional problems and possible criminality 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 thoroughly researched
      programmes specifically developed for children and young people with LD and challenging
      behaviour. NICE, therefore, recommended that further research should be undertaken to address
      the lack of evidence based interventions to reduce challenging behaviour in the population of
      young people with LD.

      In this study, the investigators propose to evaluate a programme called 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 United Kingdom, indicating that it is
      a potentially helpful. However, it needs to be tested within the UK health system before
      recommendations can be made to roll it out. Level 4 SSTP helps parents understand and manage
      their child's behaviour and parents may benefit from peer support in a group setting. The
      investigators shall recruit 258 parents who will be allocated to one of two groups by chance:
      one will receive SSTP and treatment as usual and the other treatment as usual, a list of
      resources and the Contact a Family guide to challenging behaviour. Treatment as usual
      includes support and advice by General Practitioner's or child development teams. The
      investigators shall use parental reports and observations of child behaviour to examine
      whether SSTP reduces challenging behaviour at four (short term) and 12 (long term) months
      after randomisation. They will also ask other caregivers' about the child's behaviour, 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 using both questionnaires
      and face to face interviews.The investigators shall interview the service managers and the
      therapists about their experience of hosting and delivering the intervention. Parents will
      also be recruited to the Parent Advisory Group to advise about various aspects of the study,
      e.g. materials, interview topic guides, dissemination. The researchers and clinicians have
      expertise in LD, child health and early intervention and have conducted several large trials
      with this population. The trial will last 48 months and will follow all statutory research
      governance requirements to ensure that it is high quality, safe and ethical.
    

Intervention name(s): Level 4 Stepping Stones Triple P (SSTP)
Intervention type(s): Behavioral
Intervention description(s): Stepping Stones Triple P is a system of psychoeducational and behavioural approaches to parenting a child with LD and challenging behaviour that aims to increase parental confidence and skills so that parents are able to manage the child's behavior effectively. SSTP comprises different levels based on increasing family complexity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment