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
Recruitment status was Active, not recruiting
Sponsor:
Nanjing Medical University
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01310634
First received: March 7, 2011
Last updated: March 8, 2011
Last verified: February 2011
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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 May 19, 2013