Combining emotion recognition training with oxytocin administration: A psychobiological approach
Phase 2
- Conditions
- antisocial behaviorexternalizing problems10037173
- Registration Number
- NL-OMON49988
- Lead Sponsor
- Radboud Universiteit Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
The inclusion criteria are: male, aged 12-20, living in residential youth care
facilities, capable to read and comprehend the Dutch language, exhibit
antisocial behavior and deficits in emotion recognition skills, and provide
written informed consent.
Exclusion Criteria
The exclusion criteria are: medication for severe medical problems, presence of
severe nasal disease or history of severe nasal surgery, renal or hepatic
impairment, latex allergy or intolerance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the change in emotion recognition skills from<br /><br>baseline to post-training and follow-up between the two groups (oxytocin+ERT vs<br /><br>placebo+ERT).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameters are the change in aggression, and delinquency from<br /><br>baseline to post-training and follow-up between the two groups (oxytocin+ERT vs<br /><br>placebo+ERT). We also examine whether psychological and environmental factors<br /><br>influence the effectiveness of the intervention.</p><br>