A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial.

BACKGROUND: Restricted and repetitive behaviours vary greatly across the autism spectrum, and although not all are problematic some can cause distress and interfere with learning and social opportunities. We have, alongside parents, developed a parent group based intervention for families of young children with autism, which aims to offer support to parents and carers; helping them to recognise, understand and learn how to respond to their child's challenging restricted repetitive behaviours. METHODS: The study is a clinical and cost-effectiveness, multi-site randomised controlled trial of the Managing Repetitive Behaviours (MRB) parent group intervention versus a psychoeducation parent group Learning About Autism (LAA) (n = 250; 125 intervention/125 psychoeducation; ~ 83/site) for parents of young children aged 3-9 years 11 months with a diagnosis of autism. All analyses will be done under intention-to-treat principle. The primary outcome at 24 weeks will use generalised estimating equation (GEE) to compare proportion of children with improved RRB between the MRB group and the LAA group. The GEE model will account for the clustering of children by parent groups using exchangeable working correlation. All secondary outcomes will be analysed in a similar way using appropriate distribution and link function. The economic evaluation will be conducted from the perspective of both NHS costs and family access to local community services. A 'within trial' cost-effectiveness analysis with results reported as the incremental cost per additional child achieving at least the target improvement in CGI-I scale at 24 weeks. DISCUSSION: This is an efficacy trial to investigate the clinical and cost-effectiveness of a parent group based intervention designed to help parents understand and manage their child's challenging RRB. If found to be effective, this intervention has the potential to improve the well-being of children and their families, reduce parental stress, greatly enhance community participation and potential for learning, and improve longer-term outcomes. TRIAL REGISTRATION: Trial ID: ISRCTN15550611 Date registered: 07/08/2018. Sponsor and Monitor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust R&D Manager Lyndsey Dixon, Address: St Nicholas Hospital, Jubliee Road, Gosforth, Newcastle upon Tyne NE3 3XT, lyndsey.dixon@cntw.nhs.uk , Tel: 0191 246 7222.

SafeSpot: an innovative app and mental health support package for Scottish schools - a qualitative analysis as part of a mixed methods study.

AIMS: The aim of the study was to investigate teachers' and pupils' perceptions about the effect of the SafeSpot mental health curriculum on the well-being of young people and on their knowledge of mental health conditions. This trial intends to determine the acceptability and benefits of web and mobile technology in delivering emotional well-being in schools, through use of the SafeSpot programme. BACKGROUND: With 10% of young people aged 5 to 16 diagnosed with a mental disorder, there is pressure for schools to address their pupils' emotional well-being. However, many educators report that their schools have insufficient provisions and feel inadequately equipped to support pupils' mental health. METHODS: This qualitative analysis was embedded within a randomly allocated stepped-wedge design, conducted in six West of Scotland secondary schools. A total of 2320 pupils (aged 11 to 14 years) and 90 teachers were included. Young people's understanding of health-seeking, and teacher's confidence in delivering and accessing well-being information was assessed qualitatively. RESULTS: Qualitative analysis revealed themes highlighting the beneficial nature of SafeSpot, including pupil engagement, content of tutorials, perceived impact of SafeSpot and level of training provided for teachers. CONCLUSIONS: Web technology could potentially offer a more structured way for staff to support their pupils' mental health, whilst reducing stigma. SafeSpot was perceived, by pupils and teachers, to be engaging.