Title: Evaluating an early social communication intervention for young children with Down syndrome: a feasibility study
Funder: Department of Health and Social Care

Abstract: Background: Down syndrome (DS) is a genetic disorder, affecting approximately 1 in 700 live births1 and the most common cause of learning disability2. One of the biggest challenges for individuals with DS is language, which is often lower than expected for their level of cognitive functioning. Language ability at school entry is a well-known predictor of later psychosocial and academic outcomes5 and early language skills are a primary child wellbeing indicator6 . It is therefore crucial that children with DS are given the opportunity, early on in their development, to advance their language skills, to optimise health and wellbeing outcomes for both children and their parents. To the best of our knowledge, there are no standard interventions for pre-school children with DS which focus on developing the foundation skills for language such as early social communication skills. Members of our team have developed an early intervention focusing early social communication skills and specifically on shared attention 25,45 .The intervention lasted for 10 weeks and it was delivered jointly by a researcher and a parent. Preliminary findings suggest that the intervention may benefit language outcomes for children with DS. Aim: to undertake a feasibility study to estimate the parameters to inform a future randomised controlled trial. We want to assess whether a parent-administered intervention (with some support from speech and language therapists) focusing on social communication skills in 14-24 month infants with DS can be delivered through NHS Speech and Language Therapy Services. Objectives: 1. to investigate whether parents of children with DS are willing to be allocated to treatment as usual vs intervention 2. to find out if the intervention is acceptable to speech and language therapists (SLTs), and the effectiveness of recruitment of children with DS by SLTs 3. to identify different routes to identifying eligible children with DS which could be utilised in a future trial 4. to estimate retention, completion and adherence, as well as acceptability of the intervention to parents 5. to inform the measurement of health economic outcomes and benefits of a parent-led intervention, and resource implications 6. to estimate the standard deviation of the outcome measure, which is needed to estimate sample size for a full trial 7. to find out the most appropriate measure of language ability, which will be the primary outcome measure for a full trial, and to determine a secondary outcome measure. Method: parents of children with DS will be randomised to treatment as usual (waiting control) versus parent-led intervention across 2 NHS sites. The parent-led intervention lasts 10 weeks; parents will be given a manual with instructions and will be able to access their child s speech and language therapist if they have questions. Recruitment, retention and adherence to the intervention will be measured and the acceptability of the intervention will be assessed using questionnaires and interviews. Dissemination and impact: the findings will be disseminated widely through conferences attended by practitioners, parents and SLTs, third sector organisations and through relevant publications. .

Lay abstract: Down syndrome (DS) is a relatively common genetic condition which affects approximately 1 in every 700 babies. There are approxinmately 38,000 people with DS living in England and Wales. DS is the most common cause of learning disability. Children with DS have particular difficulties with speech and language. This makes it difficult for them to participate fully in life, access health care services and educational opportunities. As DS is detected before or at birth, we can provide support from early on. There are currently no standard interventions for improving the language skills of children with DS under the age of 24 months. Existing research suggests that the earlier an intervention is carried out, the better the outcomes. Evidence also suggests that early parent-based interventions may be effective in improving language outcomes. Our preliminary work shows that an intervention focusing on early social communication skills can lead to better language in children with DS. Parents who participated in our preliminary study reported an overwhelmingly positive effect of the intervention on their children's language and communication. Also the parents were very satisfied with the manual we gave them to help them at home. Improving the language skills of young children with DS is vital for their future social and emotional well-being and behaviour, and consequently contribution to society. Our aim is to carry out a feasibility study which will inform a future pilot/full trial to test whether the intervention is effective in improving language skills before children with DS start school. The feasibility study will establish whether we could recruit enough children and parents through NHS Trusts for a full sized trial, how acceptable a parent-led intervention would be for parents and speech and language therapists, and it will provide us with information on how we may run a full trial.A Patient and Public Involvement group, which includes parents of children with DS, have been involved in the development of this proposal and will continue to be involved throughout the study.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: CONGENITAL DISORDERS;MENTAL HEALTH