There are no medical conditions or diseases under investigation, participants are healthy volunteers.
Conditions
Sponsors
Tampere University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to study the effects of intranasal OT (vs. placebo) administration to mothers on: 1. Mothers' observed interaction behavior 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 mother-child free play -Infant saccadic responses to peripheral visual stimuli in the eyetracking paradigm;Timepoint(s) of evaluation of this end point: Participants will come to the laboratory for two identical experimental sessions, separated by 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Maternal responses in the focal interaction tasks (indicating contingent responsiveness, responses to joint attention cues, and emotionregulatory behaviors);Timepoint(s) of evaluation of this end point: Secondary parameters will be assessed during the same two identical experimental sessions, separated by 4 weeks. | — |
Countries
Finland
Contacts
Public ContactTACC/Kaija Puura
Tampere University Hospital
Outcome results
None listed