Neurobiological Bases of Paternal Nurturance

April 27, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30307
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University 1462 Clifton Rd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Oxytocin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Other Names:
  • Pitocin
  • Syntocinon
  • OT
Drug: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Experimental: 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.
Drug: Placebo
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Drug: Vasopressin
1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
Other Names:
  • Argipressin
  • Arginine vasopressin (AVP)
  • Antidiuretic hormone (ADH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Signal Change in Ventral Tegmental Area (VTA)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plasma Levels of Vasopressin (AVP)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James K. Rilling, PhD

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: James K Rilling, Ph.D., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00044782
  • R21HD078778 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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