Completed

Biological Bases of Individual Variation in Paternal Nurturance

What is being tested

The Purple Cry Intervention

+ Control Intervention

Behavioral

Who is being recruted

Behavior+7

+ Brain Injuries

+ Communication

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: September 2013

See protocol details

Summary

Principal SponsorEmory University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

40 biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother will be scanned on two separate occasions. The optional second visit will occur after 2 months have passed since the first scan. In the first visit, fathers will receive two MRI scans, one before and one after completing one of the two interventions. Prior to the MRI scan, a blood sample will be collected for measurement of hormone levels. Fathers will be positioned in the MRI scanner where they will receive structural and functional MRI scans of their brain while they listen to auditory stimuli: unknown cries, own cries, and tone controls. Blood sample collection and intervention will not be conducted during the second visit.

Official TitleBiological Bases of Individual Variation in Paternal Nurturance

NCT02227979

Principal SponsorEmory University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBrain InjuriesCommunicationCryingCraniocerebral TraumaNervous System DiseasesNonverbal CommunicationWounds and InjuriesTrauma, Nervous SystemShaken Baby Syndrome

Criteria

2 inclusion criteria required to participate

biological fathers of children age 2 months or younger who are currently cohabitating with the child's mother

fathers with normal or corrected-to-normal (with contact lenses) vision

6 exclusion criteria prevent from participating

history of head trauma, seizures or other neurological disorder

psychiatric illness

alcoholism or any other substance abuse

serious medical illness

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

The PURPLE Cry Intervention group will get an 11-page booklet and 12-minute DVD to review.

Group II

Active Comparator

The control intervention group will get 1 brochure and a DVD on infant safety to review.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Emory University

Atlanta, United StatesOpen Emory University in Google Maps

CompletedOne Study Center