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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT00186472
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Brief Cognitive Behavioral Treatment
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Rebecca S Bernard, Ph.D., Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00186472
    Other Study ID Numbers:
    • NIH 5 T 32 MH19908-7
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Jun 2, 2011
    Last Verified:
    Dec 1, 2006
    Additional relevant MeSH terms:
    Disease
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic
    Stress Disorders, Traumatic, Acute

    Study Results

    No Results Posted as of Jun 2, 2011