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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-15
SponsorUniversity College Cork

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Months 0-6
2

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.

Time frame
Months 0-6
3

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.

Time frame
Months 0-6
4

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.

Time frame
Months 0-6

Secondary outcomes

Other outcomes

1

Attention-Deficit/Hyperactivity

DSM-IV criteria for attention-deficit/hyperactivity disorder (ADHD) will be assessed using the SNAP-IV 18-item scale, an abbreviated version of the Swanson, Nolan, and Pelham (SNAP) Questionnaire. Items are rated on a 4-point Likert scale with higher scores indicating higher symptom levels. The two subsets of symptoms pertain to Inattention (items 1-9) and Hyperactivity/Impulsivity (items 10-18), with possible scores ranging from 0 to 27 for each subset. The SNAP-IV will be completed by participants' parents within 72 hours prior to the at clinic visits at months 0, 2, 4, and 6.

Time frame
Months 0-6
2

Sleep disturbance

Sleep disturbance will be assessed using the Sleep Disturbance Scale for Children (SDSC), consisting of 26 items, rated on a 5-point Likert scale. The total score ranges from 26-130 with higher scores indicating higher levels of sleep disturbance. Besides the total score, 6 subscales representing more specific sleep disturbance will be calculated, i.e., difficulty in initiating and maintaining sleep (DIMS); sleep breathing disorders (SBD); disorders of arousal (DoA); sleep-wake transition disorders (SWTD); disorders of excessive somnolence (DOES); sleep hyperhidrosis (SH). The SDSC will be completed by participants' parents within 72 hours prior to the at clinic visits at months 0, 2, 4, and 6.

Time frame
Months 0-6
3

Physical Activity

Levels of physical activity over the past week will be assessed using the Physical Activity Questionnaire for Older Children (PAQ-C). The PAQ-C consists of 10-items, with items 1-9 being rated on 5-point Likert scales, scored from 1-5. The overall activity summary score is represented by the mean of items 1-9, thus ranging from 1 to 5, with higher scores indicating higher levels of physical activity. The PAQ-C will be completed by participants within 72 hours prior to the at clinic visits at months 0, 2, 4, and 6.

Time frame
Months 0-6
4

Symptoms of Mental Health Disorders

Mental health disorder symptoms will be assessed via the Development and Well-Being Assessment (DAWBA), an online questionnaire/interview package indicating likely DSM-5 psychiatric diagnoses. Participants and parents will complete the online questionnaires within 72 hours prior to Visit 1 and Visit 4. The DAWBA covers Separation anxiety, Specific phobia, Social phobia, Panic disorder / agoraphobia, Post-traumatic stress disorder, Obsessive compulsive disorder, Generalised anxiety disorder, Body dysmorphic disorder, Disruptive mood dysregulation disorder, Major depression, ADHD / hyperkinesis, Oppositional defiant disorder, Conduct disorder, Eating disorders, including anorexia, bulimia and binge eating, Autism spectrum disorders, Tic disorders, including Tourette syndrome, Bipolar disorders. Diagnostic predictions are given at probability bands, i.e., (1) less than 0.1% (--), (2) around 0.5% (-), (3) around 3% (+/-), (4) around 15% (+), (5) around 50% (++), (6) above 70% (+++).

Time frame
Month 0 and Month 6

Sponsors and contacts

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University College Cork

Lead sponsor

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

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