Clinical trial NCT03086876: Evaluation of Parent Intervention for Challenging Behaviour in Children With Intellectual Disabilities (EPICC-ID)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Challenging Behaviour
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 261
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age: Parents 18 years or over; Child aged 30-59 months at identification;
* Child has moderate to severe intellectual disability (parent reported Adaptive Behaviour Assessment System (ABAS) General Adaptive Functioning 20-69);
* Written informed consent by parent/caregiver;
* Reports of challenging behaviour over a 6-month period but no less than 2 months.

Exclusion Criteria:

* Child has mild, profound or no LD on parent reported ABAS;
* Parent/carer has insufficient English language to complete study questionnaires;
* Another sibling is taking part in the study.

Primary outcomes:
measure: Child Behaviour Check List (CBCL)
timeFrame: 12 months
Secondary outcomes:
measure: Revised Family Observation Schedule (FOS-RIII)
timeFrame: 12 months
measure: Child Behaviour Checklist Caregiver-Teacher Report Forms (C-TRF)
timeFrame: 12 months
measure: General Health Questionnaire (GHQ)
timeFrame: 12 months
measure: Questionnaire on Resources and Stress (QRS-F short form)
timeFrame: 12 months
measure: Caregiving Problem Checklist-Difficult Child Behaviour
timeFrame: 12 months
measure: Parenting Sense of Competence Scale (PSOC)
timeFrame: 12 months
measure: Child and Adolescent Service Use Schedule (CA-SUS)
timeFrame: 12 months
measure: Pediatric Quality of Life (PedsQL)
timeFrame: 12 months
measure: EuroQoL (EQ-5D)
timeFrame: 12 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 4 months
Other outcomes:
Locations:
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Central and North West London NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Northumberland, Tyne and Wear NHS Foundation Trust
Study officials:
affiliation: University College, London
name: Angela Hassiotis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farris O, Royston R, Absoud M, Ambler G, Barnes J, Hunter R, Kyriakopoulos M, Oulton K, Paliokosta E, Panca M, Paulauskaite L, Poppe M, Ricciardi F, Sharma A, Slonims V, Summerson U, Sutcliffe A, Thomas M, Hassiotis A. 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. BMC Psychiatry. 2020 Jan 30;20(1):35. doi: 10.1186/s12888-020-2451-6.