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Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhangbin Yu, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01310634
First received: March 7, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

The overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.


Condition Intervention
Depression
Behavioral: Comprehensive intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Parental anxiety symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.


Enrollment: 600
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehensive intervention
Parents of hospitalized neonates received Comprehensive intervention program.
Behavioral: Comprehensive intervention
Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.
Other Name: Comprehensive intervention program.
Conventional treatment
Usual educational program
Behavioral: Comprehensive intervention
Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.
Other Name: Comprehensive intervention program.

Detailed Description:

Parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. Parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in Chinese parents of hospitalized neonates. The aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a Chinese hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaks and reads Chinese
  • No severe handicapping conditions or mental diseases
  • Informed consent, no medical dispute
  • Infants born within 28 days to be cared in the neonatal ward for at least 24 hours

Exclusion Criteria:

  • Significant mental health history
  • Newborns died within a week after hospitalization
  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: NCT01310634

Locations
China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: Shuping Han, PhD Nanjing Medical University
  More Information

Publications:
Responsible Party: Zhangbin Yu, Director, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01310634     History of Changes
Other Study ID Numbers: NMU-FY2011-236
Study First Received: March 7, 2011
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Neonates
Parenting
Anxiety
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014