Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2011
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 28, 2014
October 1, 2014
8 months
March 7, 2011
October 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parental anxiety symptoms
Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.
3 weeks
Study Arms (2)
Comprehensive intervention
EXPERIMENTALParents of hospitalized neonates received Comprehensive intervention program.
Conventional treatment
OTHERUsual educational program
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant mental health history
- Newborns died within a week after hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, 210004, China
Related Publications (1)
Kong LP, Cui Y, Qiu YF, Han SP, Yu ZB, Guo XR. Anxiety and depression in parents of sick neonates: a hospital-based study. J Clin Nurs. 2013 Apr;22(7-8):1163-72. doi: 10.1111/jocn.12090.
PMID: 23480505RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shuping Han, PhD
Nanjing Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
January 1, 2011
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
October 28, 2014
Record last verified: 2014-10