Actively Recruiting

Phase Not Applicable
Age: 5Years - 12Years
All Genders
Healthy Volunteers
NCT06698588

Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

Led by Swansea University · Updated on 2024-11-21

200

Participants Needed

1

Research Sites

55 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

Who Can Participate

Age: 5Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Autism Spectrum Quotient 10 score greater than 5 OR Conners 3 Handscored Short Parent Form T score greater than 64 for inattention or hyperactivity subscales OR Children Sleep Habits Questionnaire SF score greater than 30
  • Able to swallow capsules
  • Age between 5 and 12 years
Not Eligible

You will not qualify if you...

  • Any major psychiatric condition likely to require hospitalization such as psychotic disorders or eating disorders
  • Severe learning difficulties such as Down syndrome
  • Any serious medical condition
  • Allergy to any ingredients of the intervention or related substances

AI-Screening

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Trial Site Locations

Total: 1 location

1

FHMLS

Swansea, United Kingdom, SA28PP

Actively Recruiting

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Research Team

H

Hayley Young, PhD

CONTACT

D

David Benton, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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