NCT05119062

Brief Summary

This is a feasibility study with pilot randomized controlled trial design. A convenience sample of 60 intergenerational co-parenting family units, including 60 first-time parents (60 mothers and 60 fathers) and 60 grandmothers (mother-in-law of mothers) will be recruited from the obstetric clinics in the outpatient department of the study hospital, with 30 family units of each in the intervention group and control group respectively. Participants who are recruited will be randomly assigned to the intervention or control group by a research assistant based on the sequential enrollment list. Participants in the control group will receive usual care. Those who are randomized to the intervention group will receive the intergenerational co-parenting program in addition to the usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

October 22, 2021

Last Update Submit

May 24, 2022

Conditions

Intergenerational RelationsPerinatal DepressionParenting

Outcome Measures

Primary Outcomes (2)

  • intergenerational co-parenting relationship

    The Chinese version of Co-parenting relationship Scale (Feinberg et al., 2012; Li \& Wei, 2018) will be used to assess the intergenerational co-parenting relationship between mothers and grandmothers reported by mothers. There are 38 items in the Chinese version of CRS. The total score ranges from 38 to 266. The Exploratory Factor Analysis adopted 7 factors. The internal consistency ranged from 0.65 to 0.87, the split half reliability was 0.60 to 0.86, and the test-retest reliability was 0.38 to 0.71. Higher scores indicate better intergenerational co-parenting relationship.

    6 weeks postpartum

  • intergenerational co-parenting relationship

    The Chinese version of Co-parenting relationship Scale (Feinberg et al., 2012; Li \& Wei, 2018) will be used to assess the intergenerational co-parenting relationship between mothers and grandmothers reported by mothers. There are 38 items in the Chinese version of CRS. The total score ranges from 38 to 266. The Exploratory Factor Analysis adopted 7 factors. The internal consistency ranged from 0.65 to 0.87, the split half reliability was 0.60 to 0.86, and the test-retest reliability was 0.38 to 0.71. Higher scores indicate better intergenerational co-parenting relationship.

    3 months postpartum

Secondary Outcomes (12)

  • The depressive symptoms of co-parenting members

    baseline at around 33-35 weeks gestation

  • The depressive symptoms of co-parenting members

    6 weeks postpartum

  • The depressive symptoms of co-parenting members

    3 months postpartum

  • The perceived stress of co-parenting members

    baseline at around 33-35 weeks gestation

  • The perceived stress of co-parenting members

    6 weeks postpartum

  • +7 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

Participants in the control group will receive usual care.

Other: Usual care

an online intergenerational co-parenting programme

EXPERIMENTAL

Those who are randomized to the intervention group will receive the intergenerational co-parenting program in addition to the usual care, including 3 weekly antenatal sessions (start from 33-35 weeks gestation) and 2 weekly postnatal sessions (start from the first week after discharge from hospital). The essential components and focus of the intergenerational co-parenting program were developed based on the themes identified from the two qualitative studies, the systematic review of co-parenting interventions, and the proposed intergenerational co-parenting model. The intervention will be delivered online through an education platform of the study hospital.

Other: an online intergenerational co-parenting programme+usual care

Interventions

Usual careOTHER

Families in the control group will be provided with routine care, including regular antenatal check ups, one bed side education (within 24 hours after delivery), one group session with discharge precautions (3rd to 5th day postpartum), two home visits (first week and second week after discharge respectively), and two physical body check at hospital on the 30th and 42nd day postpartum. Contents of the bed side education, pre-discharge education and home visits focuses on health related information, such as postpartum care, infant care and breastfeeding, etc.

Control group
an online intergenerational co-parenting programme+usual careOTHER

The program is proposed to include five sessions, with three antenatal sessions to be offered weekly during the 34-36 weeks gestation and two postnatal sessions weekly starting from the first week after discharge from hospital. The intervention will be delivered online.The program is designed for the intergenerational co-parenting families to undertake with parents together with grandmothers. The online courses will be delivered by an online platform in the study hospital. The first session will be pushed to participants in the intervention group within 2 days (around 34 weeks gestation) after recruitment. The second and third session will be pushed around 35 and 36 weeks gestation separately. The first postnatal session will be provided around the first to second week postpartum; and second postnatal session will be provided around the third to fourth week postpartum.

an online intergenerational co-parenting programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Intergeneration coparenting families will be excluded if members of the family unit with reported mental health problems, such as schizophrenia, bipolar affective disorders, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shenzhen Maternity & Child Healthcare Hospital

Shenzhen, Guangdong, 518028, China

Location

Hong Kong Polytechnic University

Hong Kong, China

Location

Related Publications (10)

  • Abidin, R. R., & Abidin, R. R. (1990). Parenting Stress Index (PSI)(p. 100).

    BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Feinberg ME, Brown LD, Kan ML. A Multi-Domain Self-Report Measure of Coparenting. Parent Sci Pract. 2012 Jan 1;12(1):1-21. doi: 10.1080/15295192.2012.638870. Epub 2012 Jan 20.

    PMID: 23166477BACKGROUND

  • Gibaud-Wallston, J., & Wandersman, L. (2001). Parenting sense of competence scale (PSOC).

    BACKGROUND

  • Li, X.W., & Wei, X.Y. (2018). Revision of the Grandparents-Parents Co-parenting Relationships Scale in Chinese Families. Chinese Journal of Clinical Psychology, 26(5):882-886. In Chinese.

    BACKGROUND

  • Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401.

    BACKGROUND

  • Wu, J.M., Li, G.J. & Zhao, H. (2017). Reliability and validity of the Chinese version of the Brief co-parenting Relationship Scale. Research on Maternal and Child Health in China, 28 (4), 369-371. In Chinese

    BACKGROUND

  • Liu CC, Chen YC, Yeh YP, Hsieh YS. Effects of maternal confidence and competence on maternal parenting stress in newborn care. J Adv Nurs. 2012 Apr;68(4):908-18. doi: 10.1111/j.1365-2648.2011.05796.x. Epub 2011 Jul 27.

    PMID: 21790741BACKGROUND

  • Ngai FW, Wai-Chi Chan S, Holroyd E. Translation and validation of a chinese version of the parenting sense of competence scale in chinese mothers. Nurs Res. 2007 Sep-Oct;56(5):348-54. doi: 10.1097/01.NNR.0000289499.99542.94.

    PMID: 17846556BACKGROUND

  • Leung C, Leung S, Chan R, Tso K, Ip F. Child behaviour and parenting stress in Hong Kong families. Hong Kong Med J. 2005 Oct;11(5):373-80.

    PMID: 16219957BACKGROUND

Study Officials

  • Ngai Feiwan, PhD

    School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 12, 2021

Study Start

November 1, 2021

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)