Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
- Conditions
- Autism spectrum disorder (ASD)
- Registration Number
- 2024-513436-14-00
- Lead Sponsor
- UZ Leuven
- Brief Summary
To evaluate the efficacy of multiple-dose oxytocin treatment on core autism symptoms using standardized assessments in children with ASD and comorbid ID.
Change from baseline after oxytocin administration on:
-Behavioral measurements of core autism (social) symptoms
-Cardio electrophysiological measurements of stress
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Children within an age-range of 4 to 13 years old with a clinical multidisciplinary diagnosis of ASD; only premenstrual girls will be included (girls with onset of menstruation during the course of the trial are allowed to continue the treatment).
Children must be enrolled in a special need school, more specific a class comprising children with an intellectual disability or meet intellectual disability criteria; a total IQ below 75 and an ABAS score below 70
Patient activelytakes anti-epileptic medication or has an active medical problem like cardiac pathology or serious liver, renal problems which influence the metabolism of oxytocin (IMP)
Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)
Significant hearing or vision impairments
Subjects who have had previous chronic treatment with oxytocin
Participation in another clinical trial with IMP
Known hypersensitivity to active substance or ingredients of the nasal spray
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Brief Observation of Social Communication Change (BOSCC) (clinician-rated) The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)
The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated) The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated)
Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest
- Secondary Outcome Measures
Name Time Method The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated) The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated)
The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated) The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated)
The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated) The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated)
The Perceived Stress Scale (PSS) (parent (caregiver)-rated) The Perceived Stress Scale (PSS) (parent (caregiver)-rated)
The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated) The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium
UZ Leuven🇧🇪Leuven, BelgiumEdward DebbautSite contact+3216343821edward.debbaut@kuleuven.be