SPECIFIC RCT Feasibility Study Version 1
Research type
Research Study
Full 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
IRAS ID
319297
Contact name
Penny A. Cook
Contact email
Sponsor organisation
Surrey and Borders Partnership NHS Foundation Trust
ISRCTN Number
ISRCTN14483801
Clinicaltrials.gov Identifier
University of Salford Ethical Approval Panel, 6895; NIHR RfPB, NIHR203536; Oglesby Charitable Trust , University of Salford 01
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
Aims of the research
• We will test a parenting course, ‘SPECIFIC’, for families affected by Fetal Alcohol Spectrum Disorder (FASD).
• The study is funded by the National Institute of Health Research (NIHR) Research for Patient Benefit (RfPB) programme and the Oglesby Charitable Trust.
• This is a feasibility test, which will show whether it is easy to get parents to join and complete the course, and if it appears to improve the lives of families. This will help us identify whether it is worth carrying out a full, definitive randomised control trial.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, 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.
• A parenting course might help to support families affected by FASD, but there is currently none especially for FASD.Design and methods
• Families will be recruited from the National FASD Clinic (Surrey), and can self-refer by responding to advertisements distributed by FASD charities.
• Families will commit to meeting online each week for the seven-week course. There are two facilitators, a trainer and an FASD-experienced parent. Families will also be asked to fill out questionnaires to measure confidence and stress in relation to parenting, wellbeing, and child behaviour.
• We will test SPECIFIC on ten groups of six families and compare findings to a control group of families that have not had the course.
• 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.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
22/NW/0287
Date of REC Opinion
7 Nov 2022
REC opinion
Further Information Favourable Opinion