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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Nanjing Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01310634
First received: March 7, 2011
Last updated: March 8, 2011
Last verified: February 2011
  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: Conventional treatment
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.

  • Parental depression symptoms [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Parents of Hospitalized Neonates were asked to complete the Self-rating Depression scale (SDS) at 3 weeks after enrolment.


Estimated Enrollment: 600
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional treatment
Parents of hospitalized neonates received usual educational-behavioral program.
Behavioral: Conventional treatment
Parents of hospitalized neonates received usual educational-behavioral program.
Other Name: Usual educational-behavioral program.
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.

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
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

No publications provided

Responsible Party: Xirong Guo, 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: March 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Neonates
Parenting
Anxiety
Depression

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

ClinicalTrials.gov processed this record on April 15, 2014