Premature Infant DiseaseNCT05592210
Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant
An observational study of Premature Infant Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Infant Disease
- What is being tested?
- Questionnaires
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2023to 1 Apr 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The parents of premature infants admitted to Peking University Shenzhen Hospital from November 2022 to November 2023.
Who may be able to join
- Parents of hospitalized preterm infants with a gestational age of less than 37 weeks;
- Both parents are at least 18 years old;
- Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator;
- Gestational age less than 37 weeks;
- admitted to the NU or NICU and discharged after treatment
Who cannot join
- Single-parent family;
- Parents diagnosed with severe anxiety and depression;
- for birth defects cannot be cured and affect the quality of life;
- infants who were given up treatment due to illness or family reasons;
- transferred or death;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hosipital
Shenzhen
Yuying Mo, bachelor, +86 15989890241, moyy9@mail2.sysu.edu.cn
About this study
The goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy.
Read the detailed description
For now, there is a lack of investigation and research on parenting stress, parenting self-efficacy and dyadic coping of co-parenting for discharged premature infants in the literature, and the mediating effect of dyadic coping between parenting stress and parenting self-efficacy of preterm parents has not been verified yet. This study aims to provide a theoretical basis for effective intervention for preterm parents with high parenting pressure and insufficient parenting self-efficacy in clinical work.
- Conditions
- Premature Infant Disease
- Being tested
- Questionnaires
- Keywords
- Premature Infant, Parental self-efficacy, Parenting Stress, Dyadic Coping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will be asked to fill out the the Demographic Information Sheet, Karitane parenting confidence scale, Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) and Dyadic Coping Inventory.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed Parents of preterm infants | Inclusion criteria for parents
1. Parents of hospitalized preterm infants with a gestational age of less than 37 weeks;
2. Both parents are at least 18 years old;
3. Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator;
Inclusion criteria for infant
1. Gestational age less than 37 weeks;
2. admitted to the NU or NICU and discharged after treatment; Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karitane parenting confidence scale
The Karitane parenting confidence scale will measure the Parenting Self-efficacy of preterm parents. The scale adopts a Likert 4-level scoring method, with 0 representing hardly ever and 3 representing most of the time. The higher the scores of each dimension and the total score, the higher the self-efficacy of the Parenting Self-efficacy of preterm parents.
Measured: baseline
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
The Parenting Stress of preterm parents will be measured by Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). The scale was scored from 1(not experient) to 5(extremely stressful) points, and the higher the score, the higher the feeling of parenting stress.
Measured: baseline
Dyadic Coping Inventory
The Dyadic Coping of preterm parents will be measured by Dyadic Coping Inventory. The total score ranges from 36 to 180.. The higher the score, the more supportive behaviors the partner gives.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start16 Mar 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
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 Premature Infant DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592210
- Sponsor's protocol ID
- preterm infant（PES）
- Status last verified
- May 2023
- First submitted
- 20 Oct 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mo Y, He W, Liu X, Xia W. Parenting Stress, Parenting Self-Efficacy and Dyadic Coping in Parents of Preterm Infants in China: A Dyadic Analysis. Nurs Open. 2026 Jul;13(7):e70700. doi: 10.1002/nop2.70700.
PubMed 42464682
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant
- ClinicalTrials.gov ID
- NCT05592210
- Acronym / sponsor ID
- preterm infant（PES）
- Conditions
- Premature Infant Disease
- Keywords
- Premature Infant, Parental self-efficacy, Parenting Stress, Dyadic Coping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Oct 2022 (actual)
- 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 goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy.
Detailed description
For now, there is a lack of investigation and research on parenting stress, parenting self-efficacy and dyadic coping of co-parenting for discharged premature infants in the literature, and the mediating effect of dyadic coping between parenting stress and parenting self-efficacy of preterm parents has not been verified yet. This study aims to provide a theoretical basis for effective intervention for preterm parents with high parenting pressure and insufficient parenting self-efficacy in clinical work.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed Parents of preterm infants | – | Other: QuestionnairesInclusion criteria for parents 1. Parents of hospitalized preterm infants with a gestational age of less than 37 weeks; 2. Both parents are at least 18 years old; 3. Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator; Inclusion criteria for infant 1. Gestational age less than 37 weeks; 2. admitted to the NU or NICU and discharged after treatment; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The parents of premature infants admitted to Peking University Shenzhen Hospital from November 2022 to November 2023.
Key inclusion criteria (5 listed)
- Parents of hospitalized preterm infants with a gestational age of less than 37 weeks;
- Both parents are at least 18 years old;
- Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator;
- Gestational age less than 37 weeks;
- admitted to the NU or NICU and discharged after treatment
Key exclusion criteria (5 listed)
- Single-parent family;
- Parents diagnosed with severe anxiety and depression;
- for birth defects cannot be cured and affect the quality of life;
- infants who were given up treatment due to illness or family reasons;
- transferred or death;
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 |
|---|---|---|
| QuestionnairesParticipants will be asked to fill out the the Demographic Information Sheet, Karitane parenting confidence scale, Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) and Dyadic Coping Inventory. | Other | Questionnaires assessed Parents of preterm infants |
Primary outcome
Karitane parenting confidence scale
Time frame: baseline
The Karitane parenting confidence scale will measure the Parenting Self-efficacy of preterm parents. The scale adopts a Likert 4-level scoring method, with 0 representing hardly ever and 3 representing most of the time. The higher the scores of each dimension and the total score, the higher the self-efficacy of the Parenting Self-efficacy of preterm parents.
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)
Time frame: baseline
The Parenting Stress of preterm parents will be measured by Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). The scale was scored from 1(not experient) to 5(extremely stressful) points, and the higher the score, the higher the feeling of parenting stress.
Dyadic Coping Inventory
Time frame: baseline
The Dyadic Coping of preterm parents will be measured by Dyadic Coping Inventory. The total score ranges from 36 to 180.. The higher the score, the more supportive behaviors the partner gives.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 42464682Mo Y, He W, Liu X, Xia W. Parenting Stress, Parenting Self-Efficacy and Dyadic Coping in Parents of Preterm Infants in China: A Dyadic Analysis. Nurs Open. 2026 Jul;13(7):e70700. doi: 10.1002/nop2.70700.
- Individual participant dataSharing planned: No
Related trials for Premature Infant Disease
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
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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.
Wei Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant Disease, run by Sun Yat-sen 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia, PhD (+86-18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karitane parenting confidence scale (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT05592210, 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 31 May 2023.