Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02227979 · ClinicalTrials.gov registry record · NA
Effects of PURPLE Cry Intervention
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT02227979 is a NA study that has completed, run by Emory University. The registered enrollment target is 42 participants.
The verdict
NCT02227979, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
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 act
Interventions
- BEHAVIORAL Control Intervention
- BEHAVIORAL The Purple Cry Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02227979
The ClinicalTrials.gov registry entry for NCT02227979 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control Intervention is the first listed.
NCT02227979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02227979 about?
NCT02227979 is a clinical study titled "Effects of PURPLE Cry Intervention". 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 ...
What is the current status of trial NCT02227979?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2013-09. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02227979?
The interventions under investigation include: Control Intervention (BEHAVIORAL), The Purple Cry Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02227979?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.