NCT06698588 Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms
| NCT ID | NCT06698588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swansea University |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2025-06-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: Autism Spectrum Quotient 10 score \>5 OR Conners 3 Handscored Short Parent Form T score \> 64 for either the inattention OR hyperactivity subscales OR Children Sleep Habits Questionnaire SF score \>30 Able to swallow capsules Exclusion Criteria: Any major psychiatric condition likely to require hospitalization (e.g., Psychotic Disorders; Eating Disorders), but NB: for representativeness of typical children with ADHD/ASD, diagnosed mood/anxiety/sleep or other neurodevelopmental disorders will not be exclusion criteria; Severe learning difficulties (e.g., Down syndrome) Any serious medical condition; (d) allergy to any ingredients of the intervention or related substances