None listed
Conditions
Brief summary
This proposal aims to evaluate whether liquid melatonin can be used to improve sleep in children aged 5-8 years with or at risk of FASD as per the Australian Guidelines for the Diagnosis of FASD. In addition we will investigate how any changes in child sleep behaviour owing to the intervention will lead to effects on parent wellbeing, child behavioural functioning, and child neuropsychological functioning.
Interventions
Prior to receiving medication treatments, parents/carers will also receive basic sleep hygiene information via a brief interview with a researcher (approximately 30 mins) and an information booklet to implement for four weeks. The sleep hygiene information will cover basic behavioral routine tips and environmental issues that can affect sleep quality that have been readily designed specifically for this study. If the study child's sleep is still disturbed after this period (ie over this period t
Prior to receiving medication treatments, parents/carers will also receive basic sleep hygiene information via a brief interview with a researcher (approximately 30 mins) and an information booklet to implement for four weeks. The sleep hygiene information will cover basic behavioral routine tips and environmental issues that can affect sleep quality that have been readily designed specifically for this study. If the study child's sleep is still disturbed after this period (ie over this period they still meet criteria), they will be entered into the melatonin/placebo treatment phase. Across a 6 week cross-over trial, children will receive sublingual liquid melatonin for a three week period and a placebo for a three week period. The order of these treatment periods will be randomised per participant. Children will be prescribed a dose of 0.1 mg of melatonin per kilogram of body weight, with a maximum dose of 6 mg. Because melatonin has a short half-life, there will be no wash out period. However, analysis after the trial may exclude the first 1-3 days of data collected from participants in the placebo phase who had previously been in the melatonin phase in an effort to minimise any carry-over effects. Participants will record their melatonin use in a sleep diary. Products will also be returned and weighed at the end of the trial.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Children aged between 5- and 12-years with confirmed prenatal alcohol exposure and who have been assessed using the Australian Guidelines for the diagnosis of FASD to have either FASD with 3 Sentinel Facial Features (SFF); FASD with < 3 SFF or “At Risk” of FASD (Bower & Elliott, 2016), and with reported sleep problems (see Inclusion Criteria). Sleep Problem Inclusion Criteria Children will be included in the study if their parents/caregivers report that they have problems with sleep initiation, whereby sleep onset latency is equal to or greater than 30 minutes, three nights or more a week, for equal to or more than three months.
Exclusion criteria
1) Are not currently receiving sedative medications, 2) Who have changed place of residence or primary carers in the last three months (as this instability may be contributing to sleep problems independent from FASD). 3) Have been diagnosed with Type 1 diabetes.
Outcome results
None listed