RecruitingNAINTERVENTIONAL

Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

This study is investigating if omega-3 fish oil supplements can help improve sleep, mood, and behaviour in children aged 5 to 12. Researchers are particularly interested in children who have sleep difficulties, or symptoms associated with autism (Autism Spectrum Disorder, ASD) or ADHD (Attention-Deficit/Hyperactivity Disorder), or both. The study takes a different approach by focusing on specific symptoms rather than requiring a formal diagnosis. This means they are including children who might not have a formal diagnosis or who have a mix of symptoms, which often happens in real life. The goal is to understand which children might benefit most from taking omega-3s.

At a glance

Status

Recruiting

Phase

Sponsor

Swansea University

Enrolment target

200

Start

07 Nov 2024

Estimated completion

01 Dec 2025

Sleep Autism or Autistic Traits ADHD or ADHD Traits

What is this study about?

This research is exploring whether giving children omega-3 fish oil supplements can help with common difficulties like sleep problems, low mood, or certain behaviours often seen in children with symptoms of autism or ADHD. It's well-known that autism and ADHD are highly varied conditions, and many children experience symptoms of both. However, past studies often excluded children with a mix of symptoms or those who hadn't received a formal diagnosis, making it harder to apply findings to real families.

Omega-3 fatty acids are really important for brain development and how the brain works, and many children in the UK, especially those with learning or behavioural challenges, don't get enough. While there aren't many fully effective treatments for all symptoms of autism or ADHD, many parents look into complementary options like omega-3s, which are quite popular. Some studies have suggested that omega-3s, particularly certain types like EPA and DHA found in fish oil, might help with things like trouble sleeping, being overly active, or having difficulty paying attention.

However, the results from different studies haven't always matched up. This might be because the studies looked at different groups of children, used different types or amounts of omega-3s, or measured improvement in different ways. This new study aims to get a clearer picture by focusing on specific symptoms rather than just diagnostic labels. By doing this, the researchers hope to better understand which children, based on their individual symptoms, are most likely to benefit from omega-3 supplementation.

Key takeaways

The study explores if omega-3s help children with sleep, mood, or behaviour.
It covers children aged 5 to 12 with autism or ADHD traits, or sleep problems.
It focuses on specific symptoms rather than only formal diagnoses.
Children will receive either omega-3 supplements or an inactive dummy pill (placebo).
Its aim is to find out which children might benefit most from omega-3s.

Who may be eligible?

This study is looking for children aged 5 to 12 years old, regardless of their gender. To be considered, a child needs to show certain levels of difficulty in specific areas.

They must either have certain scores on questionnaires related to autism traits, or difficulties with paying attention or being overly active (often linked to ADHD), or significant sleep problems. Importantly, your child must be able to swallow capsules.

Children won't be able to take part if they have a severe psychiatric condition that might need hospital care, very severe learning difficulties (like Down syndrome), a serious medical condition, or if they are allergic to any ingredients in fish oil supplements or similar products. However, if your child has a diagnosed mood, anxiety, sleep, or other neurodevelopmental condition alongside their main challenges, they generally can still take part, reflecting how common these combinations are.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 5 and 12 years old?
Does your child have significant sleep difficulties, or traits linked to autism, or difficulties with attention/hyperactivity?
Can your child swallow capsules?
Does your child have any severe medical conditions or allergies to fish oil?
Does your child have any severe psychiatric conditions that might need hospital care?
Does your child have very severe learning difficulties?

Answer every question to see your result.

What does participation involve?

The description does not specify details of participation such as the number of visits, assessment types, total duration, or follow-up schedule. Typically, studies like this might involve: taking either omega-3 fish oil supplements or a dummy pill (placebo) daily for a set period, regular check-ups or questionnaires to track symptoms, and possibly some tests related to mood, behaviour, or sleep. It would usually involve several months of taking the supplement/placebo.

Potential risks and benefits

Potential benefits of taking part might include an improvement in your child's sleep, mood, or behaviour. Even if your child doesn't receive the active omega-3 supplement, the close monitoring by the research team might provide some indirect support. There are generally very few risks associated with omega-3 supplements, which are widely available, but some children may experience mild stomach upset. The placebo is inactive and therefore carries minimal risk. You are always free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

FHMLS
Verified postcode
Swansea, United Kingdom· Recruiting

Common questions

What is omega-3 fish oil?

Omega-3 fish oil is a supplement containing essential fats that are important for brain health. They are found naturally in certain foods like oily fish.

Why are you focusing on symptoms instead of diagnoses?

Many children have a mix of symptoms that don't always fit neatly into one diagnosis. By focusing on specific symptoms like sleep problems or hyperactivity, we hope to find out which children from different backgrounds might benefit most from omega-3s.

Will my child definitely get the omega-3 supplement?

No, this is a 'placebo-controlled' study, meaning some children will receive the omega-3 supplement and others will receive a dummy pill (placebo) that looks the same but contains no active ingredients. This helps researchers fairly assess the effect of the omega-3s.

Are there any side effects of omega-3s?

Generally, omega-3 supplements are very safe. Occasionally, some children might experience mild indigestion or a 'fishy' aftertaste.

What happens if my child has both autism and ADHD symptoms?

Children with symptoms of both autism and ADHD are welcome in this study, as the research aims to include a wider range of experiences than previous studies.

How to find out more

Hayley Young, PhD

h.a.young@swansea.ac.uk 01792295607 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.