The Feasibility of an Online Intergenerational Co-parenting Program

May 24, 2022 updated by: Ngai Fei Wan, The Hong Kong Polytechnic University

The Feasibility of an Online Intergenerational Co-parenting Program for Father-mother-grandmother Triad on the Intergenerational Co-parenting Relationship in the Perinatal Period

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. A sequential enrollment list linked to a random number sequence will be generated by a statistician. 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, 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. The acceptability, feasibility of the intergeneration co-parenting program will be examined. In addtion, the preliminary effects of such program on the intergenerational co-parenting relationship between mothers and grandmothers reported by mothers (primary outcome), and on the secondary outcomes: the psychological well-being of parents and grandmothers, the co-parenting relationship between parents, parenting stress and parenting self-efficacy of parents at 6 weeks, and 3 months postpartum will be assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Hong Kong Polytechnic University
    • Guangdong
      • Shenzhen, Guangdong, China, 518028
        • Shenzhen Maternity & Child Healthcare Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the inclusion criteria for this study will be: (1) first time expectant parents (at least 18 years old) and should be married couples; (2) women have no pregnancy complications and around 34 weeks gestation (33-35 weeks); (3) women have regular antenatal check-ups in the study hospital and are going to deliver in the study hospital; (4) women living in Shenzhen together with husband, is cared by their mother-in-law at recruitment and will be taken care of by their mother-in-law in Shenzhen during the postpartum period; (5) Both parents and grandmothers could understand, read and speak mandarin and are willing to take part in this study; (6) Both parents and grandmothers are able to use smart phone and know how to use Wechat since the message from the online platform is pushed to Wechat in this study.

Exclusion Criteria:

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

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

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Control group
Participants in the control group will receive usual care.
Other: Usual care
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.
EXPERIMENTAL: an online intergenerational co-parenting programme
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
intergenerational co-parenting relationship
Time Frame: 6 weeks postpartum
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
Time Frame: 3 months postpartum
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The depressive symptoms of co-parenting members
Time Frame: baseline at around 33-35 weeks gestation
The Center for Epidemiological Studies Depression Scale (Radloff, 1977) will be used. The scale contains 20 items. The participants are asked to recall the symptoms that they experienced during the past week and respond with answers on a 4-point frequency. Each item is scored from 0 to 3, with total scores ranging from 0 to 60. A higher score indicates greater depression.
baseline at around 33-35 weeks gestation
The depressive symptoms of co-parenting members
Time Frame: 6 weeks postpartum
The Center for Epidemiological Studies Depression Scale (Radloff, 1977) will be used. The scale contains 20 items. The participants are asked to recall the symptoms that they experienced during the past week and respond with answers on a 4-point frequency. Each item is scored from 0 to 3, with total scores ranging from 0 to 60. A higher score indicates greater depression.
6 weeks postpartum
The depressive symptoms of co-parenting members
Time Frame: 3 months postpartum
The Center for Epidemiological Studies Depression Scale (Radloff, 1977) will be used. The scale contains 20 items. The participants are asked to recall the symptoms that they experienced during the past week and respond with answers on a 4-point frequency. Each item is scored from 0 to 3, with total scores ranging from 0 to 60. A higher score indicates greater depression.
3 months postpartum
The perceived stress of co-parenting members
Time Frame: baseline at around 33-35 weeks gestation
The short version of Perceived Stress Scale-4 (Cohen, 1983) will be to assess the perceived stress of co-parenting members. It consists of 4 items. Respondents rate each item with the frequency with which they experienced stress in the last month, ranging from 0 (never) to 4 (very often). The total score rangs from 0 to 16. Higher scores indicate that the respondents suffer from greater stress.
baseline at around 33-35 weeks gestation
The perceived stress of co-parenting members
Time Frame: 6 weeks postpartum
The short version of Perceived Stress Scale-4 (Cohen, 1983) will be to assess the perceived stress of co-parenting members. It consists of 4 items. Respondents rate each item with the frequency with which they experienced stress in the last month, ranging from 0 (never) to 4 (very often). The total score rangs from 0 to 16. Higher scores indicate that the respondents suffer from greater stress.
6 weeks postpartum
The perceived stress of co-parenting members
Time Frame: 3 months postpartum
The short version of Perceived Stress Scale-4 (Cohen, 1983) will be to assess the perceived stress of co-parenting members. It consists of 4 items. Respondents rate each item with the frequency with which they experienced stress in the last month, ranging from 0 (never) to 4 (very often). The total score rangs from 0 to 16. Higher scores indicate that the respondents suffer from greater stress.
3 months postpartum
Co-parenting relationship between couples
Time Frame: 6 weeks postpartum
The Chinese version of The brief Co-parenting Relationship Scale (Feinberg et al., 2012; Wu, Li & Zhao, 2017) will be used to assess the co-parenting relationship between couples. The scale contains 14 items covering seven domains. Each item is rated on a 7-point Likert Scale from 0 to 6, with total scores ranging from 0 to 84. The Cronbach's alpha of Chinese version is 0.613, and the exploratory factor analysis showed Model fit was acceptable, with a reported KMO 0.748, Bartlett's χ2=686.086, P<0.01.
6 weeks postpartum
Co-parenting relationship between couples
Time Frame: 3 months postpartum
The Chinese version of The brief Co-parenting Relationship Scale (Feinberg et al., 2012; Wu, Li & Zhao, 2017) will be used to assess the co-parenting relationship between couples. The scale contains 14 items covering seven domains. Each item is rated on a 7-point Likert Scale from 0 to 6, with total scores ranging from 0 to 84. The Cronbach's alpha of Chinese version is 0.613, and the exploratory factor analysis showed Model fit was acceptable, with a reported KMO 0.748, Bartlett's χ2=686.086, P<0.01.
3 months postpartum
Parenting stress of parents
Time Frame: 6 weeks postpartum
The parenting stress of parents will be measured using the Short Version of the Parenting Stress Index (Abidin & Abidin, 1990). The subscale of parental distress (PD) (12 items) and parent-child dysfunctional interaction (PCDI) (12 items) will be used in this study (Leung et al., 2005; Liu, Chen, Yeh, & Hsieh, 2012). The content validity of the Chinese version was 0.86 and the reliability was 0.91 after the removal of the DC subscale (Liu et al., 2012). Respondents are asked to rate the items using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores of these two subscales range from 24 to 120, with scores ranging from 12 to 60 for each subscale (Liu et al., 2012). A higher score predicts higher parenting stress.
6 weeks postpartum
Parenting stress of parents
Time Frame: 3 months postpartum
The parenting stress of parents will be measured using the Short Version of the Parenting Stress Index (Abidin & Abidin, 1990). The subscale of parental distress (PD) (12 items) and parent-child dysfunctional interaction (PCDI) (12 items) will be used in this study (Chan et al., 2005; Liu, Chen, Yeh, & Hsieh, 2012). The content validity of the Chinese version was 0.86 and the reliability was 0.91 after the removal of the DC subscale (Liu et al., 2012). Respondents are asked to rate the items using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores of these two subscales range from 24 to 120, with scores ranging from 12 to 60 for each subscale (Liu et al., 2012). A higher score predicts higher parenting stress.
3 months postpartum
Parenting self-efficacy of parents
Time Frame: 6 weeks postpartum
The Parenting Sense of Competence Scale (Gibaud-Wallston & Wandersman, 2001) will be used to assess the parenting self-efficacy of parents. This 17-item scale consists of two subscales, and has been widely used for assessments of parenting self-efficacy. Each item is rated from 1 to 6, with a total socre ranging from 17 to 102. A higher score indicates higher parenting self-efficacy. The Cronbach's alpha was 0.85 for the total scale in the Chinese version, and 0.80 and 0.77 for the subscales of Efficacy and Satisfaction, respectively. The test-retest reliability was 0.87. Good construct validity was also confirmed in the Chinese version via factor analyses, where 82% of the factors were loaded (Ngai, Chan, & Holroyd, 2007).
6 weeks postpartum
Parenting self-efficacy of parents
Time Frame: 3 months postpartum
The Parenting Sense of Competence Scale (Gibaud-Wallston & Wandersman, 2001) will be used to assess the parenting self-efficacy of parents. This 17-item scale consists of two subscales, and has been widely used for assessments of parenting self-efficacy. Each item is rated from 1 to 6, with a total socre ranging from 17 to 102. A higher score indicates higher parenting self-efficacy. The Cronbach's alpha was 0.85 for the total scale in the Chinese version, and 0.80 and 0.77 for the subscales of Efficacy and Satisfaction, respectively. The test-retest reliability was 0.87. Good construct validity was also confirmed in the Chinese version via factor analyses, where 82% of the factors were loaded (Ngai, Chan, & Holroyd, 2007).
3 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shenzhen Maternity & Child Healthcare Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ngai Feiwan, PhD, School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20210927005

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

product manufactured in and exported from the U.S.

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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