AutismENIGMA-INCT06299618
Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
An observational study of Autism and Autism Spectrum Disorder, run by University College Cork at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- How many people
- 400 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2024to Dec 2025
- Phase
- Observational
- 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Ireland1 site
University College Cork
Cork
Deirdre Murray, PhD, enigma@ucc.ie
Jean Conway, Masters, ethereal@ucc.ie
Romania1 site
University of Medicine and Pharmacy Carol Davila Bucharest
Bucharest
United Kingdom1 site
University of Southampton
Southampton
Samuele Cortese, MD
Koushik Maharatna, PhD, km3@ecs.soton.ac.uk
About this study
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.
Read the detailed description
The goal of this observational study is:
- to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
- to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.
- Conditions
- Autism, Autism Spectrum Disorder
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Carol Davila University of Medicine and Pharmacy, Microlink PC UK LTE, Engineering Ingegneria Informatica SpA, MEDEA SRL, ORTHOKEY ITALIA SRL
- Responsible party
- Principal investigator, Dr. Deirdre Murray, University College Cork
- Investigators
- Deirdre Murray, PhD, Principal investigator, University College Cork, Cork, IrelandGeraldine Boylan, PhD, Principal investigator, University College Cork, Cork, IrelandMihai Berteanu, PhD, Principal investigator, University of Medicine and Pharmacy, Bucharest, RomaniaSamuele Cortese, PhD, Principal investigator, University of Southampton, Southampton, UKKoushik Maharatna, PhD, Principal investigator, University of Southampton, Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299618
- Sponsor's protocol ID
- ENIGMA-I
- Acronym
- ENIGMA-I
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
- ClinicalTrials.gov ID
- NCT06299618
- Acronym / sponsor ID
- ENIGMA-I / ENIGMA-I
- Conditions
- Autism, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University of Southampton, Carol Davila University of Medicine and Pharmacy, Microlink PC UK LTE, Engineering Ingegneria Informatica SpA, MEDEA SRL, ORTHOKEY ITALIA SRL
- Study start
- Sep 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Mar 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.
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.
Detailed description
The goal of this observational study is:
- to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
- to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms of anxiety
Time frame: Months 0-6
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.
Symptoms of anxiety
Time frame: Months 0-6
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.
Symptoms of depression
Time frame: Months 0-6
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.
Symptoms of depression
Time frame: Months 0-6
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
Deirdre Murray, PhD principal investigator
University College Cork, Cork, Ireland
Geraldine Boylan, PhD principal investigator
University College Cork, Cork, Ireland
Mihai Berteanu, PhD principal investigator
University of Medicine and Pharmacy, Bucharest, Romania
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by University College Cork at 3 sites in 3 countries.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland, Romania, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+353(0)21 4205082, enigma@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of anxiety (time frame: Months 0-6). The study lists 4 primary outcomes in all. 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 14 Aug 2024.