Actively Recruiting
Examining Symptom-Specific Effects of Omega-3 Fatty Acids in Children with ADHD or ASD Symptoms and Sleep Problems Using a Network Approach
Led by Swansea University · Updated on 2024-11-21
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether omega-3 fatty acid supplements can improve sleep, mood, and behavior in children aged 5 to 12 who have sleep problems and symptoms of Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), or both. This study uses a novel approach focusing on specific symptoms rather than diagnostic labels to better understand which children might benefit most from omega-3 supplementation, addressing the common overlap between ASD and ADHD symptoms. Participants will be randomly assigned to receive either omega-3 fish oil supplements or a placebo. The omega-3 dose consists of three mini softgel capsules daily, providing 945 mg of long-chain omega-3 fatty acids (540 mg EPA and 405 mg DHA). The placebo contains high-oleic sunflower oil and is designed to look and taste similar to the active treatment. The intervention lasts 12 weeks. During the study, children will be assessed at the start and after 12 weeks using various questionnaires measuring symptoms such as sleep habits, autism traits, ADHD behaviors, mood, and empathy. Researchers will analyze changes in symptom networks to see how omega-3 affects key symptoms like sleep disturbances and emotional regulation. Safety and adherence will be monitored throughout the study, with usual care continuing alongside trial participation.
CONDITIONS
Brief Title
Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged between 5 and 12 years
- Autism Spectrum Quotient 10 score greater than 5 OR Conners 3 Handscored Short Parent Form T score greater than 64 for inattention or hyperactivity OR Children Sleep Habits Questionnaire SF score greater than 30
- Ability to swallow capsules
You will not qualify if you...
- Any major psychiatric condition likely to require hospitalization, such as psychotic disorders or eating disorders
- Severe learning difficulties, for example Down syndrome
- Any serious medical condition
- Allergy to any ingredients of the study supplements or related substances
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive omega-3 fish oil supplements or placebo daily to assess effects on neurodevelopmental symptoms including sleep, emotional regulation, and hyperactivity-impulsivity.
Baseline visit and 1 follow-up visit after 12 weeks
Trial Site Locations
Total: 1 location
1
FHMLS
Swansea, United Kingdom, SA28PP
Actively Recruiting
Research Team
H
Hayley Young, PhD
D
David Benton, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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