Neurobiological Bases of Paternal Nurturance
27 april 2017 bijgewerkt door: James K. Rilling, PhD
Biological Bases of Individual Variation in Paternal Nurturance
The overall goal of this project is to identify the genetic, hormonal, and neurobiological influences on paternal nurturing behavior and to determine if fathers' neural responses to infants can be modulated by neuropeptides known to play a role in parenting in experimental animal models.
The aim is to determine if pharmacological manipulation of central oxytocin (OT) and vasopressin (AVP) levels influences the neural response to viewing pictures of one's own infant or to hearing cry stimuli. In a double-blind procedure, fathers with 1-3 year old children will be scanned on two separate occasions; once under the influence of OT/AVP and once under the influence of placebo. Fathers will be randomized to either OT or AVP, and order of administration of drug and placebo will counterbalanced across subjects. Fathers will be scanned while viewing pictures of their own and an unknown child and while listening to unknown infant cry stimuli.
The investigators hypothesize:
- OT will augment the ventral tegmental area (VTA), ventral striatum and medial orbitofrontal cortex (mOFC) response to viewing pictures of one's own child, and will augment the primary auditory cortex (AI) response of fathers to infant cries.
- AVP will augment the lateral septum response to viewing own child pictures.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
30 fathers of children aged 1-3 will participate in two functional imaging sequence (fMRI) sessions, once under the influence of OT/AVP, and once under the influence of placebo.
Fathers will be restricted to men who are living with their biological child and an adult partner (male or female) that they are in a committed relationship with.
All fathers will receive two fMRI scans on two different occasions, separated by 2-10 days.
15 fathers will be randomized to intranasal OT, the other 15 will be randomized to intranasal AVP.
Within each drug group, the order of administration of drug and placebo will counterbalanced across subjects, such that 15 will receive OT/AVP first, and 15 will receive OT/AVP second.
During the fMRI scans, fathers will view pictures of their own and unknown children, as well as unknown adults.
Afterwards, while still in the scanner, they will listen to infant cry and control stimuli.
After exiting the scanner, fathers will again listen to the cry stimuli and will rate their emotional reaction to the cry stimuli on the following dimensions using a 7 point likert scale: irritated, sympathetic, alarmed, angry, upset, compassionate, distressed, annoyed, and tender.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
35
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Georgia
-
Atlanta, Georgia, Verenigde Staten, 30307
- Emory University Hospital
-
Atlanta, Georgia, Verenigde Staten, 30322
- Emory University 1462 Clifton Rd
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- above 18
- biological fathers of 1-3 year old infants who are currently cohabitating with the child's mother
- normal or corrected-to-normal vision of 20/40
Exclusion Criteria:
- current or past history of mental illness
- active medical or neurological disorder
- current or past history of alcohol or drug dependence
- claustrophobic (at the discretion of the PI with subject consultation)
- history of seizures or other neurological disorder
- history of hypertension, cardiovascular disease, nephritis, diabetes or other endocrine diseases or malignancy
- ferrous metal in any part of the body
- history of asthma or migraine headaches (can be included at the discretion of the study physician or nurse practitioner if episodes are infrequent and no active problems at time of study, not medicated)
- history of head trauma or psychiatric illness, as well as those who are receiving or have received over the past year, medication with known psychoactive effects (included at the discretion of the PI as these are exclusion criteria due to data quality concerns and not safety concerns; head trauma should be minimal enough deemed by the PI)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: OT + placebo
The OT + placebo group will self-administer no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive OT first, and half will receive OT second.
|
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andere namen:
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
|
|
Experimenteel: AVP + placebo
The AVP + placebo group will self-administer no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.
The order of administration of drug and placebo will counterbalanced across subjects, such that half will receive AVP first, and half will receive AVP second.
|
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Ventral Striatum
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Medial Orbitofrontal Cortex
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Caudate Nucleus
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in the Visual Cortex
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in the Anterior Cingulate Cortex
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
|
Baseline, Visit 2 (Up to 10 days)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Plasma Levels of Vasopressin (AVP)
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
Peripheral levels of AVP will be assessed via assay of plasma collected.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Change in Plasma Levels of Oxytocin (OT)
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
Peripheral levels of OT will be assessed via assay of plasma collected.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Difference in Cry Rating Scores Between OT and Placebo
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale.
Sixteen adjectives will be used to describe two different cries.
Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely".
Difference is defined as OT minus placebo scores.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Difference in Cry Rating Scores Between AVP and Placebo
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale.
Sixteen adjectives will be used to describe two different cries.
Participants will rate each cry from 1-7 where one represents "not at all" and 7 represents "extremely".
Difference is defined as AVP minus placebo scores.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Primary Auditory Cortex
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the OT group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
|
Mean Percent Signal Change in Right Lateral Septum
Tijdsspanne: Baseline, Visit 2 (Up to 10 days)
|
The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI).
Changes will be assessed in the AVP group only per protocol.
|
Baseline, Visit 2 (Up to 10 days)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: James K Rilling, Ph.D., Emory University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2014
Primaire voltooiing (Werkelijk)
1 februari 2016
Studie voltooiing (Werkelijk)
1 februari 2016
Studieregistratiedata
Eerst ingediend
20 augustus 2014
Eerst ingediend dat voldeed aan de QC-criteria
20 augustus 2014
Eerst geplaatst (Schatting)
22 augustus 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 juni 2017
Laatste update ingediend die voldeed aan QC-criteria
27 april 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00044782
- R21HD078778 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .