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.
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
- Conditions the study is for
- Sleep, Autism or Autistic Traits, ADHD or ADHD Traits
- 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.
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.
- Conditions
- Sleep, Autism or Autistic Traits, ADHD or ADHD Traits
- 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 group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Supplement Receives: Dietary Supplement: Omega 3 Fish Oil supplements |
| Placebo intervention | Experimental | Supplement Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted21 Nov 2024
- Study start7 Nov 2024
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Symptom-Specific Effects of Omega-3 Fatty Acids in Children With ADHD / ASD Symptoms and Sleep Problems: A Network Approach.
- ClinicalTrials.gov ID
- NCT06698588
- Acronym / sponsor ID
- SEASONS / Young 001
- Conditions
- Sleep, Autism or Autistic Traits, ADHD or ADHD Traits
- Keywords
- Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Dietary Supplement: Omega 3 Fish Oil supplementsSupplement |
| Placebo intervention | Experimental | Dietary Supplement: PlaceboSupplement |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 Fish Oil supplementsWileys Easy Swallow Mini Softgel capsules, dose 3 caps/day, providing 945mg/day long-chain omega-3 (540mg EPA, 405mg DHA). | Dietary supplement | Active intervention |
| PlaceboPlacebo: high-oleic sunflower oil (which broadly matches the overall fatty acid composition of typical UK diet), matched with active treatment for appearance and taste. | Dietary supplement | Placebo intervention |
Primary outcome
Changes in the network structure of symptoms before and after intervention.
Time frame: Baseline and after 12-weeks
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.
7 secondary outcomes
Autism Spectrum Quotient 10
Time frame: Baseline and after 12-weeks
Conners 3 Handscored Short Parent Forms
Time frame: Baseline and after 12-weeks
Childrens Sleep Habits Questionnaire - SF
Time frame: Baseline and after 12-weeks
Strengths and Difficulties Questionnaire
Time frame: Baseline and after 12-weeks
Griffith Empathy Scale
Time frame: Baseline and after 12-weeks
Child Mania Rating Scale Parent version
Time frame: Baseline and after 12-weeks
Moods and feelings Questionnaire - SF
Time frame: Baseline and after 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.