Emotion recognition training combined with oxytocin in residential youth

Phase 1

• Conditions: We examine whether oxytocin administration can improve the effectiveness of emotion recognition training compared to placebo in residential youth with antisocial behavior; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2019-001910-40-NL
• Lead Sponsor: Radboud University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 60

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The exclusion criteria are: medication for severe medical problems, presence of severe nasal disease or history of severe nasal surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to examine whether oxytocin administration can improve the effectiveness of emotion recognition training in increasing emotion recognition skills in residential youth.;Secondary Objective: The secondary aim of the study is to examine whether oxytocin administration can improve the effectiveness of emotion recognition training in reducing aggressive and delinquent behavior in residential youth. In addition, we examine the moderating effect of psychological and environmental factors in the effectiveness of the combined training. ;Primary end point(s): Change in scores of emotion recognition accuracy after the training.;Timepoint(s) of evaluation of this end point: The primary end points will be measured before the training, after the training, and at follow-up after one month.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in total scores of aggression and delinquency. <br>Psychological and environmental factors will be examined as moderators in the effectiveness of the training.;Timepoint(s) of evaluation of this end point: Aggression and delinquency will be measured before the training, after the training, and at follow-up after one month.<br>Psychological and environmental factors will be measured at the baseline measurement before the training.<br>