Effects of Omega-3 on Neurodevelopmental Symptoms
Examining Symptom-Specific Effects of Omega-3 Fatty Acids in Children with ADHD / ASD Symptoms and Sleep Problems: a Network Approach.
NA · Swansea University · NCT06698588
This study is testing if giving omega-3 fish oil supplements can help improve sleep, mood, and behavior in children with sleep problems and symptoms of Autism or ADHD.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Swansea University (other) |
| Locations | 1 site (Swansea) |
| Trial ID | NCT06698588 on ClinicalTrials.gov |
What this trial studies
This study investigates whether omega-3 fatty acid supplementation can enhance sleep, mood, and behavior in children experiencing sleep issues and symptoms of Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD). By employing a transdiagnostic approach, the research aims to identify specific symptoms that may benefit from omega-3 supplementation, thus including a broader range of children than previous studies. The trial will compare the effects of omega-3 fish oil supplements against a placebo to determine efficacy. The study addresses a significant gap in treatment options for children with these neurodevelopmental conditions.
Who should consider this trial
Good fit: Ideal candidates include children with sleep problems and symptoms of ASD or ADHD, particularly those who may not have a formal diagnosis.
Not a fit: Patients with major psychiatric conditions requiring hospitalization or severe learning difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective complementary treatment option for children with ASD and ADHD symptoms.
How similar studies have performed: Previous studies have shown mixed results regarding omega-3 supplementation for similar conditions, indicating that while there is potential, the approach remains somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Swansea
- FHMLS — Swansea, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Hayley Young, PhD
- Email: h.a.young@swansea.ac.uk
- Phone: 01792295607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep, Autism or Autistic Traits, ADHD or ADHD Traits, Randomised Controlled Trial