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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
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.
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% (+++).
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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