Work

A Pilot Randomised Controlled Trial of Sublingual Melatonin for Sleep Onset Insomnia in Children With Foetal Alcohol Spectrum Disorder ( FASD )

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: AIM: Children with foetal alcohol spectrum disorder (FASD) present with significant sleep disturbance. This pilot trial aimed to examine the feasibility of conducting a larger randomised controlled trial (RCT) in this population and the potential effectiveness of melatonin to treat onset insomnia. METHODS: Children with sleep onset delay and a designation of 'at risk' of FASD or a diagnosis of FASD were recruited to a 10-week, double-blind, placebo-controlled, crossover study of melatonin. Sleep outcomes were assessed using actigraphy. The child sleep habit questionnaire (CSHQ) and measures of executive functioning and carer stress were completed at baseline and after each treatment phase. RESULTS: Fifty-nine children were assessed for eligibility, 18 were ineligible as they were taking sleep medication, and eight children entered the trial. Four received melatonin for 3 weeks followed by placebo for 3 weeks (arm A) and four received placebo followed by melatonin (arm B). Processes involving data collection and retention were acceptable. However, significant issues regarding recruitment were found. Quantitative measures were appropriate with significant reductions in sleep onset latency (n = 6) in the melatonin condition relative to the placebo condition (p = 0.003), and bedtime resistance (n = 8) according to the CSHQ (p = 0.004). No serious adverse events were reported. CONCLUSIONS: A randomised crossover design was feasible in this population; however, recruitment should be conducted across multiple sites. Melatonin is potentially effective at reducing sleep onset latency and behaviour difficulties at bedtime in children with or 'at risk' of FASD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (12619001360101).

Source: Journal of Paediatrics and Child Health

DOI: 10.1111/jpc.70224

Authors: Ned Chandler‐Mather, Doug Shelton, Caroline Donovan, Haydn Till, Bronwyn M. Theroux, Sharon Dawe

Institutions: Griffith University, Gold Coast Hospital, Gold Coast Health

Language: English

Topic: Sleep and related disorders

Subfield: Experimental and Cognitive Psychology

Field: Psychology

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: green

Funder: Department of Health and Aged Care, Australian Government