In this study we will try to replicate and extend the findings of Domes et al (2007) of oxytocin effects on *mind-reading* in two specific groups of participants; i.e. in a group of high-functioning individuals with autism, and a normal comparison…
ID
Source
Brief title
Condition
- Other condition
- Disturbances in thinking and perception
Synonym
Health condition
sociale informatieverwerking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Social information processing based on the results of the REMT, EMG, Emotional
stroop and cry task, and within the group of fathers also sensitivity measured
using the EAS.
Secondary outcome
NVT
Background summary
Oxytocin ia a neuropeptide which is involved in social- and parent-child
interaction. It is reported that a single dose of oxytocin may contribute to
improvement of social interaction and 'mind-reading' (Domes et al., 2007).
People with autism have distinct difficulties in social interaction and
especially in interpreting social cues.
Study objective
In this study we will try to replicate and extend the findings of Domes et al
(2007) of oxytocin effects on *mind-reading* in two specific groups of
participants; i.e. in a group of high-functioning individuals with autism, and
a normal comparison group existing of a group men between 20 and 35 years of
age and a group of parents with young typically developing children. In a
double-blind placebo-controlled within- and between-subject design we will
investigate the effects of a single dose of intranasal oxytocin on perception.
Next, we will investigate the effects of oxytocin on parental behaviour in the
group of parents of young infants.
Study design
In a double-blind placebo-controlled within- and between-subject design we will
investigate the effects of a single dose of intranasal oxytocin on perception.
Next, we will investigate the effects of oxytocin on parental behaviour in the
group of fathers of young infants.
Intervention
NVT
Study burden and risks
There are no benefits for the participants, since the effects of oxytocin on
social information processing for individuals with and without autism spectrum
disorders must be investigated.
The drawback of participating in this study is the time needed. For both
assessment, participants need to go to the hospital (about 4 hours totally).
Also they will be asked to complete questionnaires (about half an hour
totally).
The study*s advantage is that when is found that oxytocin has a positive effect
on social information processing, oxytocin nasal spray might be included in
intervention programs for autism and parenting.
Scientifically the purposed study will give more insight in the effect of
oxytocin on social information processing in individuals with autism spectrum
disorders compared to individuals without autism spectrum disorders and effects
of oxytocin to sensitivity of fathers towards their child.
Intranasal oxytocin is widely prescribed in lactating woman and is well
tolerated. Several studies have been conducted in humans with doses between 20
and 60 IU, and no adverse side effects have been reported (e.g. Bruins et al.,
1992; Fehm-Wolfsdorf et al., 1988; Pitman et al., 1993; Heinrichs et al.,
2003). Based on the doses that will be used during this study and the effects
of oxytocin nasal spray in general, there will be no risk for the participants
in this study.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
group with autism; male and diagnosed with ASD according to criteria DSMIV and voluntary participation
group adult males without children; voluntary participation
group fathers; voluntary participation and child between 1.5 and 5 years of age
group fathers with a child with ASD: voluntary participation and a child between 1.5 and 5 years of age with ASD
Exclusion criteria
group with autism; other medical problems, smoking, use of medication
control groups; smoking, use of medication
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
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2008-000192-15-NL |
CCMO | NL22761.041.08 |