Behavior Problem Clinical Trial
Official title:
Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs
The aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. The study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers.
Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial
behavior. However it is less known whether the same effect could be achieved in younger
children. Furthermore it is not known whether omega-3 fatty acids could also improve parental
behavior and parenting style which could further reduce behavioral problems in children.
Moreover, we recently found that children who consume fish more frequently have less sleep
problems but it is not known whether omega-3 supplements could also potentially improve
children's sleep. We aim to test several hypotheses in this random controlled trial of
omega-3 fatty acids.
The study design will consist of a double-blind, randomized placebo-controlled trial of
children and their caregivers in a community sample in the city of Philadelphia. It will
utilize a random parallel design, in which child and mother pairs will be randomly assigned
to either omega-3 supplementation (treatment condition) or a placebo (control condition).
This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent
and child receiving the placebo. Treatment will last 45 days. Assessments will take place at
0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of
treatment).
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