Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
Carmen M Schroder, Beth A Malow, Athanasios Maras and 7 others
PMID 31079275WHAT IT FOUND
Children with autism and poor sleep who took prolonged-release melatonin had fewer outward-directed behavior problems than children taking placebo after 13 weeks, and caregivers reported better wellbeing.
Social withdrawal and anxiety did not change clearly in the whole group.
Key findings
01Prolonged-release melatonin improved externalizing behavior compared with placebo, but did not significantly improve internalizing behavior in the total group.
02Caregiver wellbeing improved by 2.17 points on the 25-point WHO-5 scale compared with placebo after 13 weeks.
03In children with abnormal hyperactivity/inattention scores at baseline, melatonin improved externalizing behavior and total difficulties compared with placebo.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The trial was powered for sleep outcomes, not behavior outcomes. Many behavioral endpoints were exploratory, and no correction for multiple comparisons was applied. The study relied on caregiver reports and did not use child reports. The study did not assess school performance or intellectual outcomes. The effects of the highest dose on behavior were not assessed. Subgroup analyses included small numbers of children with abnormal conduct scores.
The easy way to misread this
Do not conclude that prolonged-release melatonin treats all behavioral difficulties in autism. The trial showed a clear improvement in outward-directed behavior and caregiver wellbeing, but social withdrawal and anxiety did not change clearly in the total group, and the study was designed and powered for sleep rather than behavior.