DepressionNCT01310634
Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
A study testing Comprehensive intervention in people with Depression, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Comprehensive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant mental health history
- Newborns died within a week after hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Comprehensive intervention
- Keywords
- Neonates, Parenting, Anxiety, Depression
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive interventionBehavioural
Also called Comprehensive intervention program.
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive intervention | Experimental | Parents of hospitalized neonates received Comprehensive intervention program. Receives: Behavioral: Comprehensive intervention |
| Conventional treatment | Other | Usual educational program Receives: Behavioral: Comprehensive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental anxiety symptoms
Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Shuping Han, PhD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310634
- Sponsor's protocol ID
- NMU-FY2011-236
- Status last verified
- Oct 2014
- First submitted
- 7 Mar 2011
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23480505
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
- ClinicalTrials.gov ID
- NCT01310634
- Acronym / sponsor ID
- NMU-FY2011-236
- Conditions
- Depression
- Keywords
- Neonates, Parenting, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive intervention | Experimental | Behavioral: Comprehensive interventionParents of hospitalized neonates received Comprehensive intervention program. |
| Conventional treatment | Other | Behavioral: Comprehensive interventionUsual educational program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant mental health history
- Newborns died within a week after hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive interventionAlso: Comprehensive intervention program.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. | Behavioural | Comprehensive intervention, Conventional treatment |
Primary outcome
Parental anxiety symptoms
Time frame: 3 weeks
Parents of Hospitalized Neonates were asked to complete the Self-rating Anxiety Scale (SAS) at 3 weeks after enrolment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Results publication: PubMed 23480505Kong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuping Han, PhD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive intervention in people with Depression, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental anxiety symptoms (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01310634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.