Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

NCT06299618 | Not Yet Recruiting

• 1 other identifier: ENIGMA-I
• Study Type: observational
• Target: 400
• Locations: 3 countries
• Sites: 3

Brief Summary

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

Conditions

Autism; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Symptoms of anxiety

  Symptoms of anxiety will be assessed via the Anxiety Scale for Children (ASC-ASD). The ASC-ASD is a 24 item self-report for use with young people aged between 8-16 years with a diagnosis of Autism. Items are rated on a 4-point Likert scale, ranging from 0 to 3. Total score range from 0 to 72, with higher scores indicating higher levels of anxiety. The ASC-ASD will be completed by participants at the clinic visits at month 0, 2, 4, and 6.

  Months 0-6

• Symptoms of anxiety

  Symptoms of anxiety will be assessed via the Revised Children's Anxiety and Depression Scale-25 (RCADS-25). The RCADS-25 is a 25-item self-report, rendering an anxiety subscale with 14 items. Items are scored on a 4-point Likert scale with higher scores representing greater symptom severity. Scores for the anxiety subscale range from 0 to 42. The RCADS-25 will be completed biweekly over the 6-month study duration.

  Months 0-6

• Symptoms of depression

  Symptoms of depression will be assessed via the Beck Depression Inventory for Youth (BDI-Y). The BDI-Y is a 20-item self report. Items are scored on a 4-point Likert scale ranging from 0 to 3. Total scores range from 0 to 60 with higher scores indicating higher symptom severity. The BDI-Y will be completed by participants at the clinic visits at month 0, 2, 4, and 6.

  Months 0-6

• Symptoms of depression

  Symptoms of depression will be assessed via Revised Children's Anxiety and Depression Scale-25 (RCADS-25). The RCADS-25 is a 25-item self-report, rendering a depression subscale with 10 items. Items are scored on a 4-point Likert scale with higher scores representing greater symptom severity. Scores for the depression subscale range from 0 to 30. The RCADS-25 will be completed biweekly over the 6-month study duration.

  Months 0-6

Other Outcomes (12)

• Attention-Deficit/Hyperactivity

  Months 0-6

• Sleep disturbance

  Months 0-6

• Physical Activity

  Months 0-6

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from paediatric and community paediatric clinics. Participants may also be identified through open invitations on websites, social media pages, and through a study specific social media page.

You may qualify if:

• Autistic Adolescents
• Must be able to interact verbally
• Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol
• Must be willing to return for all study visits and wear the study device at home
• Must have access to and be able to operate a smartphone.

You may not qualify if:

• Adolescents with severe motor impairments or schizophrenia
• Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes.
• Intellectual disability, not capable to attend mainstream school

Sponsors & Collaborators

• University College Cork: lead
• University of Southampton: collaborator
• Carol Davila University of Medicine and Pharmacy: collaborator
• Microlink PC UK LTE: collaborator
• Engineering Ingegneria Informatica SpA: collaborator
• MEDEA SRL: collaborator
• ORTHOKEY ITALIA SRL: collaborator

Study Sites (3)

University College Cork

Cork, Ireland

Location

University of Medicine and Pharmacy Carol Davila Bucharest

Bucharest, Romania

Location

University of Southampton

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Deirdre Murray, PhD

  University College Cork, Cork, Ireland

  PRINCIPAL INVESTIGATOR

• Geraldine Boylan, PhD

  University College Cork, Cork, Ireland

  PRINCIPAL INVESTIGATOR

• Mihai Berteanu, PhD

  University of Medicine and Pharmacy, Bucharest, Romania

  PRINCIPAL INVESTIGATOR

• Samuele Cortese, PhD

  University of Southampton, Southampton, UK

  PRINCIPAL INVESTIGATOR

• Koushik Maharatna, PhD

  University of Southampton, Southampton, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+353(0)21 4205082; enigma@ucc.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Deirdre Murray

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: March 8, 2024
• Study Start: September 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

RO (1); IE (1); GB (1)