NCT05592210

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 16, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

October 20, 2022

Last Update Submit

May 28, 2023

Conditions

Keywords

Premature InfantParental self-efficacyParenting StressDyadic Coping

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    baseline

Study Arms (1)

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;

Other: Questionnaires

Interventions

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.

Questionnaires assessed Parents of preterm infants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The parents of premature infants admitted to Peking University Shenzhen Hospital from November 2022 to November 2023.

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hosipital

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Wei Xia, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 24, 2022

Study Start

March 16, 2023

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations