Title: Parenting course for parents of children with fetal alcohol spectrum disorders (FASD) versus waitlist: a randomised controlled feasibility study of the SPECIFIC (Salford Parents and carers’ Education Course for Improvements in Fasd outcomes In Children) Programme
Funder: Department of Health and Social Care

Abstract: Good parenting is vital for children's healthy social and emotional development. If parents are having difficulties, evidence shows that parenting programmes help, both for typical children and also when specially developed for other groups such as those with autism spectrum disorder. However, there is no parenting programme for children with Fetal Alcohol Spectrum Disorders (FASD), a condition caused by alcohol consumption during pregnancy. Children with FASD have lifelong damage to the brain, leading to language, social, behavioural and other difficulties, putting them at increased risk of school exclusion, mental ill-health, and involvement in the criminal justice system. FASD is common, likely affecting 2-4% of children. However FASD has a complex presentation, which can make it difficult to diagnose. Experienced parents tell us that children with FASD need to be parented differently because strategies used with typical children are ineffective. In partnership with families, using funding from the Medical Research Council, we created an FASD parenting programme, 'SPECIFIC', using the best available evidence. This innovative programme is for those who care for children with a recent FASD diagnosis. It can be delivered by the NHS or voluntary sector organisations. SPECIFIC is a seven-week programme, where groups of six families meet weekly using video conferencing, along with an experienced trainer/therapist and an FASD-experienced parent. We tested SPECIFIC on two groups (nine families) and everyone found it helpful. Ultimately, our aim is to conduct a randomised controlled trial, to identify whether SPECIFIC improves the lives of families and is cost effective. First, we are seeking funding to conduct an initial feasibility trial. Using a waitlist design, 120 families will be recruited through two specialist clinics and via the FASD support organisations. Ten groups of six families (60 families) will receive SPECIFIC and will be compared to a waitlist group of 60 families. At baseline and then two months after the intervention has finished, we will measure parent stress (using the Parenting Stress Index) as the candidate primary outcome for the main trial, and secondary outcomes including parenting self-efficacy, children s behavioural difficulties and health-related quality of life. After follow-up measures have been taken, the controls will receive SPECIFIC. Our feasibility study will provide vital evidence in advance of the main trial, including: Recruitment and retention rates; Demonstration of a signal of efficacy to justify progression to a definitive trial Indicative costs to inform future cost effectiveness analysis We have secured funding from the Oglesby Charitable Trust to pay for delivery and research costs of SPECIFIC, making this proposal exceptional value for money. It is vital to do this work now because the National Institute of Health and Care Excellence (NICE) is publishing Quality Standards, which will mandate that support is available for families. There are currently no recommended interventions for families affected by FASD. Ultimately our aim is that, should it be shown effective in a future definitive trial, SPECIFIC will be recommended by NICE. Our network of partners will then ensure SPECIFIC is rolled out quickly so that thousands more families can benefit.

Lay abstract: Aims of the research We want to test a new parenting course, called SPECIFIC. The course is for parents of children with Fetal Alcohol Spectrum Disorder (FASD). We hope that eventually the NHS and charities will be able to deliver the course to thousands of families. First we need to do a smaller test called a feasibility test. This will tell us whether it is worth doing a bigger test, called a randomised control trial. This small-scale test will show whether it is easy to get parents to join and complete the programme, and if it appears to improve the lives of families. Background to the research FASD is caused by drinking alcohol in pregnancy. Children with FASD have damage to the brain for the rest of their life. It makes it difficult to communicate, keep friendships, and stay calm and still, among other difficulties. They are more likely to be excluded from school. As grownups, they might suffer from mental ill-health, or get in trouble with the law. New research shows FASD is very common, affecting 2- 4% of children. This makes it more common than autism, but it is underdiagnosed. When a child gets diagnosed with FASD, the parents need help. A parenting course might help, but there is no course especially for FASD. This makes it difficult for doctors to know what to recommend. Recently, the Department of Health and Social Care said we need &ldquo;innovative approaches&rdquo; to support those with FASD. The new National Institute for Health and Clinical Excellence (NICE) Quality Standard on FASD says each child should have a plan that &ldquo;signposts to resources and services&rdquo;. Our project fills these needs. Design and methods used SPECIFIC is a seven-week course where families meet online each week. There are two facilitators, one is a trainer and the other is an FASD-experienced parent. We will test SPECIFIC on ten groups of six families and compare findings with families that have not had the course. The families that have not had the course are called a 'control group'. After the course, we will measure the parents stress levels and their parenting confidence. As soon as we have done the comparison, the control group will also get the training course. Patient and public involvement Parents of people with FASD, charities and experts helped us to develop SPECIFIC. We also trained nine families using SPECIFIC. These families helped us to make it better. Families will continue to be involved by helping us to run the project and analyse the data. Dissemination We will write up our results in academic publications. The charities we work with will help us to tell the FASD community about our research.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL