- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186472
Intervention to Decrease Anxiety in Parents of Infants in the Neonatal Intensive Care Unit (NICU)
May 31, 2011 updated by: Stanford University
Infants born premature face numerous medical problems, causing significant anxiety for their parents.
Parents experience a range of negative emotions including concern for the health and well being of their fragile infant, guilt, and disappointment.
Research has indicated that having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for parents and multiple studies have demonstrated that parents can develop significant psychological reactions to this experience.
Specifically, many parents develop clinically significant anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress disorder (PTSD).
This not only impacts the mental well-being of the parents, but also can lead to problems with the parent-infant relationship, and, in turn, negatively impact the infant and the family as a whole.
Despite the reported negative effects parents experience due to the stress of having an infant on the NICU, surprisingly little research has examined how to reduce parents' symptoms of anxiety.
Because parents play an essential role in the care of their infant after discharge from the NICU, treating the parent's emotional distress is highly important.
The purpose of this study is to examine the efficacy of a cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety associated with having an infant on the NICU.
This treatment is modeled after treatments that have proven effective with parents of children with other types of medical problems, for example, parents of children with cancer.
It is the hope of the investigators that this intervention will effectively reduce symptoms of anxiety of NICU parents as well as the likelihood of developing subsequent psychological disorders.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
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
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California
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Stanford, California, United States, 94305
- Stanford University
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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
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older;
- Participants speak either English or Spanish;
- The participant's infant is expected to live;
- The participant's infant was born at Lucile Packard Children's Hospital or transferred to the hospital within 72 hours;
- Participant's infant is over 1000 grams
Exclusion Criteria:
- Individuals under 18 years of age;
- Individuals who do not speak either English or Spanish;
- Individuals whose infant was not born at or transferred to (within 72 hours of The infant's birth) Lucile Packard Children's Hospital;
- Individuals whose infant has a life threatening condition and is not expected to survive;
- Current drug abuse/dependence
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca S Bernard, Ph.D., Stanford University
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 Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
June 2, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH 5 T 32 MH19908-7
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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