The primary aim of this study is to examine the effectiveness of a psychobiological intervention combining oxytocin administration with ERT. We hypothesize that the combined intervention will be more effective in improving emotion recognition skills…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the change in emotion recognition skills from
baseline to post-training and follow-up between the two groups (oxytocin+ERT vs
placebo+ERT).
Secondary outcome
The secondary parameters are the change in aggression, and delinquency from
baseline to post-training and follow-up between the two groups (oxytocin+ERT vs
placebo+ERT). We also examine whether psychological and environmental factors
influence the effectiveness of the intervention.
Background summary
Youth with antisocial behavior often exhibit deficits in emotion recognition
that contribute to aggression and delinquency. A new emotion recognition
training (ERT) has been developed and empirical evidence has supported its
effectiveness in juvenile offenders who showed improved emotion recognition
after training and a significant reduction in the severity of crimes. In
addition, oxytocin administration can also improve emotion recognition in
healthy samples and residential youth. A novel approach is to combine oxytocin
administration with ERT to examine whether this combination can lead to better
treatment outcomes.
Study objective
The primary aim of this study is to examine the effectiveness of a
psychobiological intervention combining oxytocin administration with ERT. We
hypothesize that the combined intervention will be more effective in improving
emotion recognition skills compared to the ERT combined with placebo. As
secondary objectives, we investigate whether the combined training can reduce
aggression or delinquency and whether the effectiveness of the intervention is
moderated by psychological and environmental factors.
Study design
This is a randomized, double-blind, placebo-controlled, between-subjects study
including five steps: screening, baseline measurement, training, post-training
measurement, and follow-up. During the training (3 sessions), participants will
be randomly allocated to either oxytocin or placebo condition. Participants in
oxytocin condition will receive the ERT in combination with 24 IU of oxytocin
with a nasal spray 30 minutes before each treatment session, whereas
participants in the placebo condition will receive the ERT with placebo.
Intervention
One group will receive a dose of 24 IU oxytocin with a nasal spray before each
session of the emotion recognition training and the other group will receive
placebo before the emotion recognition training.
Study burden and risks
Previous meta-analyses revealed that oxytocin administration has no severe
side-effects or adverse events and it is safe in research settings. The
participants will be directly benefited from the study as a combined
intervention will be administered aiming at improving emotion recognition
skills. The emotion recognition training is brief and easy for the participants
without any significant burden.
Montessorilaan 3
Nijmegen 6525HR
NL
Montessorilaan 3
Nijmegen 6525HR
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001910-40-NL |
| CCMO | NL70016.091.19 |
| OMON | NL-OMON20174 |