Effects of PURPLE Cry Intervention
Public ClinicalTrials.gov record NCT02227979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Biological Bases of Individual Variation in Paternal Nurturance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation. The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following: * independent variables that may affect a father's neural response to infant cries * effects of the PURPLE cry intervention, compared to a control intervention, on fathers' reported aversiveness and empathy in response to cry stimuli * effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural response to unknown infant cries compared to a tone control * effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural responses to own infant cries compared to unknown infant cries The investigators hypothesize: * prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be modulated by the following variables: subjective self-reported emotional reaction to cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant temperament, life stressors, parental expectations, personality (neuroticism), and father's own childhood experience * fathers who receive the PURPLE material compared to those that receive the control intervention will report a larger decrease in aversiveness and a larger increase in empathy in response to cry stimuli * fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger decrease in activity in the anterior insula and amygdala in response to cry stimuli * fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger increase in activity in regions of the brain important for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC * fathers' neural activity in the amygdala in response to their own infant's cry stimuli will be positively correlated with both their own and infant testosterone levels
Study identification
- NCT ID
- NCT02227979
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2013
- Primary completion
- Jan 31, 2016
- Completion
- Jan 31, 2016
- Last update posted
- Apr 7, 2016
2013 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02227979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2016 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02227979 live on ClinicalTrials.gov.