Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
Overview
- Phase
- Phase III and phase IV (Integrated)
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- UZ Leuven
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
Kaat Alaerts
Scientific
UZ Leuven
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated)
- The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated)
- The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated)
- The Perceived Stress Scale (PSS) (parent (caregiver)-rated)
- The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)