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: female adults having a 6-8 year old child and a mother willing to participate. -Grandmothers: female adults, whose daughter with a 6-8 year old child is willing to participate. -Children: 6-8 year old boys and girls. 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: -Mothers, grandmothers, and children: o Any known neurological and (uncorrected) visual impairments o Psychiatric disorders -Mothers and grandmothers: o smoking o alcohol and drug abuse o pregnancy o breastfeeding o use of medication, except oral contraceptives o MRI contraindications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to investigate: - effects of oxytocin on mothers’ and grandmothers’ neural activity related to empathic responding to their (grand)children. We expect oxytocin to decrease activity in brain areas associated with hyperarousal and fear, increase activity in brain regions associated with social cognition, and facilitate empathic responses. We expect changes in brain activity to be related to increases in empathy. - effects of oxytocin on mothers’ and grandmothers’ neural activity in response to stimuli designed to elicit protective responses; pictures of their own and other (grand)children preceded by a mildly threatening prime. We expect oxytocin to reduce amygdala activation, reflecting reduced arousal and fear thereby promoting adaptive (protective) responding. - effects of oxytocin on mothers’ and grandmothers’ sensitive responsiveness toward their (grand)children. - the role of the oxytocin receptor gene in moderating effects of administered oxytocin.;Secondary Objective: Secondary objectives are to investigate: - effects of oxytocin on grandmother-mother interactions. - the potential relations between the (grand)child’s rejection sensitivity and both mother’s and grandmother’s empathic responding to the child. - the potential relations between the grandmother’s, mother’s, and child’s level of empathic behavior. ;Primary end point(s): The main study parameters are: - Activity in brain areas associated with (hyper)arousal and fearfulness (notably the amygdala), as well as social cognition, attachment, and empathy (e.g., superior temporal cortex, inferior frontal gyrus, fusiform gyrus, insula). We will examine the effects of oxytocin on activity in these areas in both mothers and grandmothers during a priming task designed to elicit protective responses and during a cyberball task designed to elicit empathic responses and behavior. In addition, we will examine whether effects of oxytocin are moderated by the oxytocin receptor gen | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters are: -Interactive behavior of mother and grandmother during a family interaction task (FIT; Allen et al., 2003). We will examine the effects of oxytocin on grandmother-mother interactions. In addition we will examine whether effects of oxytocin are moderated by the oxytocin receptor genotype. -The child’s empathic behavior and rejection sensitivity. We will investigate potential relations between children’s, mothers’, and grandmothers’ levels of empathic behavior. We will investigate whether children’s rejection sensitivity is related to their mothers’ and grandmothers’ empathic behavior toward them during the cyberball game and to their mothers’ and grandmothers’ sensitive responsiveness toward them (under placebo conditions). ;Timepoint(s) of evaluation of this end point: Secondary parameters will be assessed during the same two identical experimental sessions, seperated by 4 weeks. | — |
Countries
Netherlands
Outcome results
None listed