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
Funder: Department of Health and Social Care

Abstract: DESIGN: Two arm multicentre pragmatic single blind randomised controlled trial of level 4 Stepping Stones Triple P (SSTP) and TAU versus TAU alone. SETTING: NHS, social care and third sector services in England TARGET POPULATION: Children aged 30 to 59 months with moderate to severe intellectual disability (ID) and challenging behaviour. INCLUSION CRITERIA: Parents aged 18 years and over; child aged 30-59 months with moderate to severe ID (ABAS general adaptive composite 20-69); parent/service concerns about challenging behaviour over 6 but no less than 2 months; informed consent by parent EXCLUSION CRITERIA: Child has mild, profound or no LD; parent/carer has insufficient English language to complete study questionnaires; another sibling is taking part in the study. HEALTH TECHNOLOGY BEING ASSESSED: Weekly 6 x 2.5 hours group sessions followed by 3 x half hour individual contacts of level 4 SSTP delivered by trained practitioners in addition to TAU. TREATMENT AS USUAL: Any type of care currently available to families and their children with challenging behaviour. The control group will also receive a list of local and national resources and the Contact a Family guide to challenging behaviour. MEASUREMENT OF COST & OUTCOMES: The primary outcome is parent reported reduction in challenging behaviour at 12 months post randomisation using the parent completed preschool Child Behaviour Checklist (CBCL). Secondary outcomes measured at baseline, 4 and 12 months are: Direct parent-child observations (Revised Family Observation Schedule, FOS-RIII); caregiver reported child behaviour (Child Behaviour Checklist Caregiver-Teacher Report Forms; C-TRF); parent psychiatric morbidity (General Health Questionnaire, GHQ-12); parenting activities (Questionnaire on Resources and Stress, QRS-F); frequency of behaviour severity during care-giving tasks (Caregiving Problem Checklist-Difficult Child Behaviour); satisfaction and efficacy as parent (Parenting Sense of Competence Scale, PSOC), health related quality of life (Pediatric Quality of Life, PedsQL), health and social care service use (study specific Child and Adolescent Service Use Schedule, CA-SUS); Parent health related quality of life (EQ-5D). Other: child level of disability (Mullen Sclaes of Early Development, if not previously assessed); parent intervention acceptability (Client Satisfaction Questionnaire). Sociodemographic and clinical information will be captured by the Case Report Form. The measures are appropriate to this type of study and are meaningful to parents and clinicians. SAMPLE SIZE, RECRUITMENT and INTERNAL PILOT A sample of 258 children is required to detect a low to moderate (standardised) effect size of 0.40 for the primary outcome CBCL at 12 months, at 5% significance level with 90% power; this is equivalent to detecting a clinically important difference of 8 points, (standard deviation=20). We assume a correlation of 0.5 between baseline and follow-up measurements, 10% attrition and clustering in the SSTP arm only (ICC=0.05 and group size=7). The sample size is based on 3:2 randomisation which allows for clustering and is relatively easy to implement. A 7 month internal pilot will be carried out prior to embarking on the full trial in order to test the study processes, acceptability of the intervention and flow of participants into the study.

Lay abstract: About 1-2% of the population have a Learning (also called intellectual) disability (LD). This is a lifelong condition characterised by an IQ 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, we 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 UK, 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. We 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 GPs or child development teams. We 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. We shall also ask other carergivers' 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. 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. We are a group of researchers and clinicians with expertise in LD, child health and early intervention who have conducted several large trials with this population. Our trial will last 48 months and will follow all statutory research governance requirements to ensure that it is high quality, safe and ethical.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH