Symptom-specific Effects of Omega-3 Across Neurodevelopmental Symptoms

NCT06698588 | Recruiting

• 1 other identifier: Young 001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Sleep; Autism or Autistic Traits; ADHD or ADHD Traits

Keywords

Randomised Controlled Trial

Outcome Measures

Primary Outcomes (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.

  Baseline and after 12-weeks

Secondary Outcomes (7)

• Autism Spectrum Quotient 10

  Baseline and after 12-weeks

• Conners 3 Handscored Short Parent Forms

  Baseline and after 12-weeks

• Childrens Sleep Habits Questionnaire - SF

  Baseline and after 12-weeks

• Strengths and Difficulties Questionnaire

  Baseline and after 12-weeks

• Griffith Empathy Scale

  Baseline and after 12-weeks

Other Outcomes (2)

• Arrow flanker

  Baseline and after 12-weeks

• Stop signal task

  Baseline and after 12-weeks

Study Arms (2)

Active intervention

EXPERIMENTAL

Supplement

Dietary Supplement: Omega 3 Fish Oil supplements

Placebo intervention

EXPERIMENTAL

Supplement

Dietary Supplement: Placebo

Interventions

Omega 3 Fish Oil supplements DIETARY_SUPPLEMENT

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

Active intervention

Placebo DIETARY_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.

Placebo intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Swansea University: lead

Study Sites (1)

FHMLS

Swansea, SA28PP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Central Study Contacts

Hayley Young, PhD

CONTACT

01792295607; h.a.young@swansea.ac.uk

David Benton, PhD

CONTACT

d.benton@swansea.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 21, 2024
• Study Start: November 7, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-10

Locations

GB (1)