Neurobiological Bases of Paternal Nurturance
27 avril 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
35
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Georgia
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Atlanta, Georgia, États-Unis, 30307
- Emory University Hospital
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Atlanta, Georgia, États-Unis, 30322
- Emory University 1462 Clifton Rd
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
|
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Plasma Levels of Vasopressin (AVP)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: James K Rilling, Ph.D., Emory University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2014
Achèvement primaire (Réel)
1 février 2016
Achèvement de l'étude (Réel)
1 février 2016
Dates d'inscription aux études
Première soumission
20 août 2014
Première soumission répondant aux critères de contrôle qualité
20 août 2014
Première publication (Estimation)
22 août 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 juin 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00044782
- R21HD078778 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
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