Neurobiological Bases of Paternal Nurturance
27 aprile 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
35
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Georgia
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Atlanta, Georgia, Stati Uniti, 30307
- Emory University Hospital
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University 1462 Clifton Rd
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
|
|
Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Plasma Levels of Vasopressin (AVP)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: James K Rilling, Ph.D., Emory University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2014
Completamento primario (Effettivo)
1 febbraio 2016
Completamento dello studio (Effettivo)
1 febbraio 2016
Date di iscrizione allo studio
Primo inviato
20 agosto 2014
Primo inviato che soddisfa i criteri di controllo qualità
20 agosto 2014
Primo Inserito (Stima)
22 agosto 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 giugno 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 aprile 2017
Ultimo verificato
1 aprile 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00044782
- R21HD078778 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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