Oxytocin and mother-infant interactio
- Conditions
- There are no medical conditions or diseases under investigation,participants are healthy volunteers.Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2014-005431-13-FI
- Lead Sponsor
- Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
In order to be eligible to participate in this study, a subject must meet
the following criteria:
Mothers: healthy female subjects, 20-40 years old, mothers of children
younger than 9 months
Children: healthy infants, approximately 9 months old during
the first laboratory visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A potential subject who meets any of the following criteria during a
telephone prescreening will be excluded from participation in this study:
-Breastfeeding
-Any known neurological, visual, and auditory impairment
-Use of medication (except oral contraceptives)
-Drug or alcohol abuse
-Psychiatric disorder
-Nasal disease or obstruction
-Smoking
-Pregnancy
-Cardiovascular disease
For the children:
-Premature birth (<37 weeks)
-Low birth weight (<2500 g)
-Diagnosis of a neurological or visual disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of the study are to study the effects of intranasal OT (vs. placebo) administration to mothers on:<br>1. Mothers' observed interaction behavior<br>2. Children's sensitivity to the emotional signals of others (via OT-induced effects on mothers' interactive behavior);Secondary Objective: The secondary objective of the study is to study the effects of intranasal OT (vs. placebo) administration to mothers on specific facets of interactive behaviors with one's own child;Primary end point(s): -Maternal sensitivity scores on the Emotional Availability Scales during<br>mother-child free play<br>-Infant saccadic responses to peripheral visual stimuli in the eyetracking<br>paradigm;Timepoint(s) of evaluation of this end point: Participants will come to the laboratory for two identical experimental<br>sessions, separated by 4 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Maternal responses in the focal interaction tasks (indicating contingent<br>responsiveness, responses to joint attention cues, and emotionregulatory<br>behaviors);Timepoint(s) of evaluation of this end point: Secondary parameters will be assessed during the same two identical<br>experimental sessions, separated by 4 weeks.