Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorSwansea University
About this trial
Our study aims to determine whether omega-3 fatty acid supplementation can improve sleep, mood, and behavior in children with sleep problems and symptoms of Autism Spectrum Disorder (ASD), Attention-Deficit/Hyperactivity Disorder (ADHD), or both. By using a transdiagnostic approach-focusing on specific symptoms rather than diagnostic labels-we aim to identify which children may benefit most from omega-3 supplementation, thereby enhancing inclusivity. Many previous studies have excluded children with both ASD and ADHD, or those without a formal diagnosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Omega 3 Fish Oil supplements
Dietary supplementWileys Easy Swallow Mini Softgel capsules, dose 3 caps/day, providing 945mg/day long-chain omega-3 (540mg EPA, 405mg DHA).
Placebo
Dietary supplementPlacebo: high-oleic sunflower oil (which broadly matches the overall fatty acid composition of typical UK diet), matched with active treatment for appearance and taste.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Active interventionExperimental treatment 1 intervention
Group B: Placebo interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in the network structure of symptoms before and after intervention.
This involves identifying shifts in symptom interconnectivity, which can indicate improvements in symptom clustering (e.g., a reduction in connections around "bridge" symptoms like emotional dysregulation or sleep disturbances). All questionnaires mentioned in secondary outcomes are used in the network.
Time frame
Baseline and after 12-weeksSecondary outcomes
1
Autism Spectrum Quotient 10
Linear mixed model - For comparison with other trials that investigated Omega 3 on ASD symptoms
Time frame
Baseline and after 12-weeks2
Conners 3 Handscored Short Parent Forms
Linear mixed model - For comparison with other trials that investigated Omega 3 on ADHD symptoms including Inattention; Hyperactivity; Executive Functioning; Defiance/Aggression; Peer relations
Time frame
Baseline and after 12-weeks3
Childrens Sleep Habits Questionnaire - SF
Linear mixed model - For comparison with other trials that investigated Omega 3 on sleep
Time frame
Baseline and after 12-weeks4
Strengths and Difficulties Questionnaire
Linear mixed model - For comparison with other trials that investigated Omega 3 on emotional problems including Emotional symptoms; Conduct problems; Hyperactivity/inattention; Peer relationship problems; Prosocial behavior
Time frame
Baseline and after 12-weeksOther outcomes
1
Arrow flanker
Online tests
Time frame
Baseline and after 12-weeks2
Stop signal task
Online tests
Time frame
Baseline and after 12-weeksSponsors and contacts
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Source ClinicalTrials.gov