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Intervention to Decrease Anxiety in Parents of Infants in the Neonatal Intensive Care Unit (NICU)

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186472
First received: September 13, 2005
Last updated: May 31, 2011
Last verified: December 2006
  Purpose

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.


Condition Intervention
Anxiety
Acute Stress Disorder
Posttraumatic Stress Disorder
Depression
Behavioral: Brief Cognitive Behavioral Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Stanford University:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. Participants speak either English or Spanish;
  3. The participant's infant is expected to live;
  4. The participant's infant was born at Lucile Packard Children's Hospital or transferred to the hospital within 72 hours;
  5. Participant's infant is over 1000 grams

Exclusion Criteria:

  1. Individuals under 18 years of age;
  2. Individuals who do not speak either English or Spanish;
  3. Individuals whose infant was not born at or transferred to (within 72 hours of The infant's birth) Lucile Packard Children's Hospital;
  4. Individuals whose infant has a life threatening condition and is not expected to survive;
  5. Current drug abuse/dependence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186472

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Rebecca S Bernard, Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Richard Shaw, M.D., Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186472     History of Changes
Other Study ID Numbers: NIH 5 T 32 MH19908-7
Study First Received: September 13, 2005
Last Updated: May 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Stress Disorders, Traumatic, Acute
Behavioral Symptoms
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014