A randomised, parallel groups evaluation of a parental group sleep education intervention in young children with Down syndrome: the REST-Ed study
Down syndrome; Sleep disorders
Parents /carers of children aged 6 months - 5 years with Down Syndrome living in Scotland are invited to take part. All children taking part have a sleep study at home to test for breathing problems during sleep. If a sleep breathing problem is found, the child leaves the research study and is sent for further assessment and treatment locally. The parents of the remaining children are chosen at random using balanced blocks to receive the education package (intervention group) or a short talk on another non-sleep-related topic (control group). The intervention is a sleep education package, based on the package evaluated by Stores & Stores (Stores, R. and Stores, G. (2004), Evaluation of Brief Group-Administered Instruction for Parents to Prevent or Minimize Sleep Problems in Young Children with Down Syndrome). This study evaluates a modified version of the Stores and Stores package, including a DVD, booklet and talk delivered in a small-group setting. Sleepiness, behaviour and quality of life of children and parents/carers is assessed using questionnaires at the start of the study and at 1 month, 6 month and 12 month follow-up visits. Sleep quality is measured using a wrist-worn device called an actigraph, again at 1, 6 and 12 month intervals. Participants in the control group are offered the education package at the end of the study, with 1 month follow-up if they wish.
1. Child has known diagnosis of Down syndrome (trisomy 21, mosaic or translocation karyotype) 2. Child aged 0.5 - 5.0 years at baseline visit 3. Child and parent/carer resident in Scotland for the study duration 4. Parent able and willing to comply with protocol
1. Child has a previous diagnosis of sleep-disordered breathing (SDB), whether treated or untreated, or evidence of SDB on home cardio-respiratory polygraphy at screening (children showing evidence of SDB at screening will be signposted for further assessment/treatment as required via their local NHS pathway) 2. Child has severe or uncontrolled comorbidities affecting sleep or ability to participate, e.g. uncontrolled epilepsy, chronic lung disease, uncorrected congenital heart defects 3. Child is currently using medication which may affect sleep, e.g. melatonin, sedating antihistamines, benzodiazepines, chloral hydrate etc 4. Child has severe behavioural problems which would preclude compliance with home cardio-respiratory polygraphy or actigraphy 5. Not resident in Scotland for duration of study 6. Parent unable or unwilling to comply with protocol