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AzTrials

SleepSEASONSNCT06698588

Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

A study testing Omega 3 Fish Oil supplements in people with Sleep and Autism or Autistic Traits, run by Swansea University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 12 yearsHealthy volunteers can take part
What is being tested?
Omega 3 Fish Oil supplements
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited Kingdom
Study dates
7 Nov 2024to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • FHMLS

    Swansea, SA28PP

Other trials in United Kingdom

About this study

Official title: Examining Symptom-Specific Effects of Omega-3 Fatty Acids in Children With ADHD / ASD Symptoms and Sleep Problems: A Network Approach.

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.

Read the detailed description

ASD and ADHD are highly diverse neurodevelopmental conditions with significant co-occurrence-some estimates suggest rates as high as 78% (Leitner, 2014). However, research often excludes neurodiverse children with co-occurring conditions or subclinical symptoms, making many study populations unrepresentative of real-world scenarios. Currently, there are no fully safe and effective treatments for ASD or ADHD symptoms (Groom \& Cortese, 2022; Oono et al., 2013; Williams et al., 2010), which leads many parents to explore complementary treatments, such as omega-3 supplements, among the most popular options (Green et al., 2006; Sinha \& Efron, 2005). Omega-3s, essential for brain development and function, are often deficient in UK children, particularly those with behavioral or learning difficulties (Montgomery et al., 2014).

Some clinical trials suggest that omega-3 supplementation, specifically EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), can improve symptoms such as sleep disturbances, hyperactivity-impulsivity, and inattention in children with ADHD and/or ASD-like difficulties (Bent et al., 2014; Richardson \& Montgomery, 2005). However, findings across studies have been inconsistent, with systematic reviews and meta-analyses yielding varied conclusions (Abdullah et al., 2019; Bloch \& Qawasmi, 2011; Gillies et al., 2012). These discrepancies likely arise from variations in study populations, treatments, outcome measures, and trial designs.

A key limitation is the traditional approach of treating ASD and ADHD as distinct diagnostic categories, adhering to the "latent variable" model in psychiatry, which assumes that symptoms reflect an underlying disorder. This approach has two major flaws: (a) it encourages studying groups presumed homogeneous based on diagnosis, ignoring within-group variability and symptom overlap across disorders, and (b) it directs treatment toward presumed underlying diseases rather than focusing on specific symptoms and their interactions. This "one-size-fits-all" model may contribute to the inconsistent findings in omega-3 research for neurodevelopmental conditions.

In contrast, network science offers a more dynamic approach, viewing disorders as networks of interacting symptoms rather than symptoms being caused by a single underlying disorder. This approach enables visualization of symptom networks, including complex connections that explain symptom overlap. For instance, "bridge" symptoms link different disorder domains, while "central" symptoms, which are highly connected, drive other symptoms and may be ideal treatment targets. Monitoring symptom networks during treatment can help identify individuals more likely to benefit based on unique symptom profiles (Bringmann et al., 2022; Bekhuis et al., 2018).

To date, the network approach has not been used to explore how omega-3 supplementation affects ASD and ADHD symptoms. Our study aims to apply this method to: (a) better understand the shared features of ADHD and ASD by identifying "bridge symptoms" and examining whether omega-3 supplementation influences these symptoms; (b) identify phenotypes that cross diagnostic boundaries and might benefit from omega-3 supplementation; and (c) promote a more inclusive approach to treating ADHD/ASD symptoms by focusing on symptom profiles rather than diagnostic labels.

We hypothesize that sleep disturbances and emotional dysregulation will act as "bridge nodes" that connect ADHD and ASD, given their presence across multiple disorders. Based on prior studies (Montgomery et al., 2014; Richardson, 2006; Richardson \& Montgomery, 2005), we also propose that omega-3 supplementation will directly improve a cluster of symptoms related to sleep, emotional regulation, and hyperactivity-impulsivity. Any additional benefits are expected to be indirect, resulting from improvements in these key symptoms.

Being tested
Omega 3 Fish Oil supplements, Placebo
Keywords
Randomised Controlled Trial
Medical subject headings
Autistic Disorder, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega 3 Fish Oil supplementsDietary supplement

    Wileys Easy Swallow Mini Softgel capsules, dose 3 caps/day, providing 945mg/day long-chain omega-3 (540mg EPA, 405mg DHA).

  • PlaceboDietary supplement

    Placebo: high-oleic sunflower oil (which broadly matches the overall fatty acid composition of typical UK diet), matched with active treatment for appearance and taste.

Study groups in NCT06698588
Study groupRoleWhat they receive
Active interventionExperimentalSupplement
Receives: Dietary Supplement: Omega 3 Fish Oil supplements
Placebo interventionExperimentalSupplement
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and after 12-weeks

Secondary outcomes (7)
  1. Autism Spectrum Quotient 10

    Linear mixed model - For comparison with other trials that investigated Omega 3 on ASD symptoms

    Measured: Baseline and after 12-weeks

  2. 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

    Measured: Baseline and after 12-weeks

  3. Childrens Sleep Habits Questionnaire - SF

    Linear mixed model - For comparison with other trials that investigated Omega 3 on sleep

    Measured: Baseline and after 12-weeks

  4. 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

    Measured: Baseline and after 12-weeks

  5. Griffith Empathy Scale

    Linear mixed model - For comparison with other trials that investigated Omega 3 on cognitive empathy and affective empathy

    Measured: Baseline and after 12-weeks

  6. Child Mania Rating Scale Parent version

    Linear mixed model - For comparison with other trials that investigated Omega 3 on mania

    Measured: Baseline and after 12-weeks

  7. Moods and feelings Questionnaire - SF

    Linear mixed model - For comparison with other trials that investigated Omega 3 on mood

    Measured: Baseline and after 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start7 Nov 2024
  3. Primary completion1 Jan 2026
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Whilst we are conducting an RCT we are planning on taking a modern approach to data-analysis - time-varying network analysis. This approach moves beyond the traditional medical model and its diagnostic categories where the assumption is that symptoms stem from a common underlying cause, and treating that cause (via medication or therapy) should alleviate the symptoms. This approach has been largely unsuccessful. In contrast, network analysis views mental health disorders as complex, interrelated systems of symptoms and does not lend itself to calculating composite of global scores (see project description for further information.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06698588
Sponsor's protocol ID
Young 001
Acronym
SEASONS
Status last verified
Oct 2024
First submitted
13 Nov 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Omega 3 Fish Oil supplements in people with Sleep and Autism or Autistic Traits, run by Swansea University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the network structure of symptoms before and after intervention. (time frame: Baseline and after 12-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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