- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592210
Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant
May 28, 2023 updated by: Wei XIA, PhD, Sun Yat-sen University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
308
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei Xia, PhD
- Phone Number: +86-18823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Contact Backup
- Name: Yuying Mo
- Phone Number: +86-15989890241
- Email: moyy9@mail2.sysu.edu.cn
Study Locations
-
-
-
Shenzhen, China
- Recruiting
- PeKing University ShenZhen Hosipital
-
Contact:
- Yuying Mo, bachelor
- Phone Number: +86 15989890241
- Email: moyy9@mail2.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The parents of premature infants admitted to Peking University Shenzhen Hospital from November 2022 to November 2023.
Description
Inclusion criteria for parents
- 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;
Inclusion criteria for Infants
- Gestational age less than 37 weeks;
- admitted to the NU or NICU and discharged after treatment
Exclusion criteria for parents
- Single-parent family;
- Parents diagnosed with severe anxiety and depression;
Exclusion criteria for Infants
- 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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Questionnaires assessed Parents of preterm infants
Inclusion criteria for parents
Inclusion criteria for infant
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Xia, PhD, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
October 20, 2022
First Submitted That Met QC Criteria
October 20, 2022
First Posted (Actual)
October 24, 2022
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 28, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- preterm infant(PES)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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