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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2011

Last Updated Date

March 8, 2011

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Measure of parental anxiety symptoms: Self-rating Anxiety Scale(SAS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Measure of parental depression symptoms: Self-rating Depression scale(SDS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01310634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Behavioral: Conventional treatment
Parents of hospitalized neonates received usual educational-behavioral program.

Other Name: Usual educational-behavioral 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.

Study Arm (s)

No Intervention: Conventional treatment
Parents of hospitalized neonates received usual educational-behavioral program.

Intervention: Behavioral: Conventional treatment
Experimental: Comprehensive intervention
Parents of hospitalized neonates received Comprehensive intervention program.

Intervention: Behavioral: Comprehensive intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

December 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01310634

Other Study ID Numbers ^ICMJE

NMU-FY2011-236

Has Data Monitoring Committee

Yes

Responsible Party

Xirong Guo, Nanjing Medical University

Study Sponsor ^ICMJE

Nanjing Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Shuping Han, PhD

Nanjing Medical University

Information Provided By

Nanjing Medical University

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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