Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms (NCT06698588) | Clinical Trial Compass
CompletedNot Applicable
Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms
United Kingdom200 participantsStarted 2024-11-07
Plain-language 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.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used omega-3 supplements to look at sleep, autism traits, and ADHD traits together as a connected network of symptoms — does that approach make sense for my child's or my specific combination of symptoms, and what does it mean for how we'd interpret any results?
2Since this trial is already completed, would my doctor be able to access or share the findings, and do the results suggest omega-3 had any meaningful effect on the kinds of symptoms I'm dealing with?
3This study didn't have a traditional phase, which suggests it may have been more of an observational or exploratory study rather than a rigorous efficacy trial — how much confidence should I place in its findings compared to a Phase 3 randomized controlled trial?
4Given that the trial measured changes in how symptoms are connected to each other rather than just reducing individual symptoms, is that kind of 'network structure' outcome something that would actually change what treatments my doctor recommends for me?
5Before considering omega-3 supplementation based on this or similar research, are there standard, already-proven treatments for sleep problems, ADHD, or autism traits that my doctor thinks I should try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the network structure of symptoms before and after intervention.