There are no medical conditions or diseases under investigation MedDRA version: 14.1 Level: PT Classification code 10033329 Term: Oxytocin System Organ Class: 10022891 - Investigations
Conditions
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: -Mothers: healthy female subjects, 25-40 years old -Grandmothers: healthy female subjects, 50-65 years old -Infants: healthy infants, 5-6 months old during the first laboratory visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: -To investigate with observational and electrophysiological techniques mothers' defensive reactivity in contexts where their infant is associated with a minor threat and modulation of such reactivity by intranasal oxytocin administration. -To investigate whether oxytocin administration increases mothers and grandmothers' sensitivity towards their children and grandchildren.;Secondary Objective: Secondary Objectives: -To measure concordance in mothers' and grandmothers' salivary oxytocin levels in the oxytocin and placebo conditions and to also measure infants' salivary oxytocin levels in response to putative differences in caregiving sensitivity by the mother and grandmother in the oxytocin vs. placebo conditions. -To assess the mothers' and grandmothers' attachment representations of one another and the potential modulation of such representations by oxytocin administration.;Primary end point(s): There are three main study parameters. First, we will use EEG to measure neural responses to own vs. unfamiliar infant's images after priming the images with threat-related vs. neutral prime stimuli. EEG will be analyzed with respect to asymmetric activity within the alpha frequency band over frontal electrode sites. Second, video recordings of the Enthusiastic Stranger Paradigm will focus on the mothers' defensive and protective responses such as signs of vigilance and concern, as well as more direct verbal or behavioral attempts to interrupt the stranger. Third, standard procedures will be followed to measure mothers' and grandmothers' caregiving sensitivity in the oxytocin vs. placebo conditions.;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): First, in the EEG task, we will also analyze attention-related event-related potentials (ERPs) in response to the infant stimuli. While ERPs are not as direct measures of motivational approach tendencies as frontal EEG asymmetry, they can importantly complement the EEG asymmetry data by potentially revealing oxytocin-induced differences in ERPs reflecting the strength of automatic attention orienting to the infant stimuli. Second, saliva samples will be collected three times during the lab visit to measure whether a) oxytocin levels in saliva show a reliable increase after oxytocin administration, b) the amount of increase in salivary oxytocin is similar in mothers and grandmothers, and c) the expected differences in caregiving sensitivity by the mother and grandmother in the oxytocin vs. placebo conditions are accompanied by differential salivary oxytocin responses in the infants. Third, the mother and the grandmother are also administered the Experiences in Close Relationships-Relationship Structures (ECR-RS; Fraley, Heffernan, Vicary, & Brumbaugh, 2011) questionnaire to assess their attachment representations toward each other and to analyze whether such representations are affected by oxytocin.;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
Netherlands
Outcome results
None listed