In this study neural responses to infant crying will be measured with fMRI. In addition, the neural base of emotion understanding will be examined with fMRI. Participants will look at pictures of adults and infant and they have to infer the mental…
ID
Source
Brief title
Condition
- Other condition
- Family issues
Synonym
Health condition
risk for child abuse
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
fMRI: we expect changes in brain activation in region involved in emotion
regulation during exposure to infant crying compared to control sounds. We also
expect a change in activation in these regions when participants are presented
with pictures of adults and infant with emotional face expressions, compared to
a control task. In addition, we expect oxytocin effects on brain activation
during these empathy tasks and during infant crying.
Secondary outcome
not applicable
Background summary
Annually 30 out of 1,000 children in the Netherlands suffer from child
maltreatment. Previous research has indicated that
mothers at risk for maltreating their children (often assessed with the Child
Abuse Potential Inventory) show increased
physiological responses to infant crying sounds and have lower levels of
empathy than low risk individuals. However, little
research has been done on the neural responses to infant crying and the neural
base of empathy in individuals at risk for
child abuse. As child abuse is a major cause for deviant child development, the
study of the physiological mechanisms
underlying child abuse is crucial.
Study objective
In this study neural responses to infant crying will be measured with fMRI. In
addition, the neural base of emotion understanding will be examined with fMRI.
Participants will look at pictures of adults and infant and they have to infer
the mental state. Participants have been screened for risk for child abuse in
a previous study with the Child Abuse Potential Inventory and have scores on
this questionnaire ranging from low to high. We will examine the relation
between child abuse risk and neural responses to infant crying and during 2
empathy tasks.
The aim of the study is to gain more insight in the physiological mechanisms
that are involved in child abuse. In addition, we want to examine the effects
of oxytocin on neural responses to infant crying and on the neural circuitry
underlying empathy.
Study design
This is a randomized, placebo-controlled, double-blind, between-subjects design
to assess how oxytocin influences neural responses to infant crying and the
neural empathy circuitry. The participants will receive oxytocin or a plabeo
(24 IU oxytocin Syntocinon, Novartis) 40 minutes before fmri scanning.
Neural responses to infant crying will be measured with fMRI. In addition, the
neural base of emotion understanding will be examined with fMRI. Participants
will look at pictures of adults and infant and they have to infer the mental
state.
Intervention
Oxytocin or placebo administration: half of the participants will receive
oxytocin or placebo
Study burden and risks
The maximum duration of the labsession is 1,5 hour. De participants will be
scanned with fMRI when they are listening to infant crying and when they are
performing 2 empathy tasks. There are no known risks associated with
participating in an fMRI study.Numerous children and adults have undergone
magnetic resonance studies without apparent harmful consequences. Some people
become claustrophobic while inside the magnet and in these cases the study will
be terminated immediately at the subject's request. The only absolute
contraindications to MRI studies are the presence of intracranial or
intraocular metal, or a pacemaker. Relative contraindications include pregnancy
and claustrophobia. Subjects who may be pregnant, who are claustrophobic, who
may have metallic foreign bodies in the eyes or head, or who have cardiac
pacemakers will be excluded because of potential contraindications of MRI in
such subjects.
During the session the subjects will take 6 puffs of nasal spray containing 4
IU/ puff of oxytocin (Syntocinon, Novartis), or 6 puffs
of a placebo-spray (NaCl solution). Intranasal oxytocin is widely prescribed in
lactating women and is well tolerated. High doses
(> 60 IU) of oxytocin nasal spray may in some cases lead to headache. Based on
the single doses of 24 IU (i.e. 6 puffs, each
containing 4 IU of oxytocin) that will be used during this study and the
effects of oxytocin nasal spray in general, there will be low
risk for the participants in this study.
wassenaarseweg 52
2333 AK Leiden
NL
wassenaarseweg 52
2333 AK Leiden
NL
Listed location countries
Age
Inclusion criteria
woman, 18-30 years old, without children
Exclusion criteria
Potential participants for the fMRI session will be prescreened for contra-indications for fMRI, which include metal implants, heart arrhythmia, claustrophobia, and possible pregnancy. They will additionally be prescreened for head trauma, drug or alcohol abuse and psychiatric disorder. Women younger than 18 years old and older than 30 years old and men are excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
EudraCT | EUCTR2011-002537-20-NL |
CCMO | NL37166.058.11 |