Intergenerational RelationsNCT05119062
The Feasibility of an Online Intergenerational Co-parenting Program
A study of Intergenerational Relations and Perinatal Depression, run by The Hong Kong Polytechnic University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intergenerational Relations, Perinatal Depression, Parenting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2021to 10 May 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intergeneration coparenting families will be excluded if members of the family unit with reported mental health problems, such as schizophrenia, bipolar affective disorders, etc.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hong Kong Polytechnic University
Hong Kong
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, Guangdong, 518028
About this study
Official title: 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.
Read the 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.
- Conditions
- Intergenerational Relations, Perinatal Depression, Parenting
- Being tested
- Usual care, an online intergenerational co-parenting programme+usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants in the control group will receive usual care. Receives: 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. Receives: Other: an online intergenerational co-parenting programme+usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months postpartum
Secondary outcomes (12)
The depressive symptoms of co-parenting members
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.
Measured: baseline at around 33-35 weeks gestation
The depressive symptoms of co-parenting members
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.
Measured: 6 weeks postpartum
The depressive symptoms of co-parenting members
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.
Measured: 3 months postpartum
The perceived stress of co-parenting members
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.
Measured: baseline at around 33-35 weeks gestation
The perceived stress of co-parenting members
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.
Measured: 6 weeks postpartum
The perceived stress of co-parenting members
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.
Measured: 3 months postpartum
Co-parenting relationship between couples
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.
Measured: 6 weeks postpartum
Co-parenting relationship between couples
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.
Measured: 3 months postpartum
Parenting stress of parents
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.
Measured: 6 weeks postpartum
Parenting stress of parents
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.
Measured: 3 months postpartum
Parenting self-efficacy of parents
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).
Measured: 6 weeks postpartum
Parenting self-efficacy of parents
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).
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Nov 2021
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intergenerational RelationsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Responsible party
- Principal investigator, Ngai Fei Wan, The Hong Kong Polytechnic University
- Investigators
- Ngai Feiwan, PhD, Principal investigator, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119062
- Sponsor's protocol ID
- HSEARS20210927005
- Status last verified
- May 2022
- First submitted
- 22 Oct 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abidin, R. R., & Abidin, R. R. (1990). Parenting Stress Index (PSI)(p. 100).
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.
PubMed 6668417Feinberg 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.
PubMed 23166477Gibaud-Wallston, J., & Wandersman, L. (2001). Parenting sense of competence scale (PSOC).
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.
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.
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
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.
PubMed 21790741Ngai 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.
PubMed 17846556Leung 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.
PubMed 16219957
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of an Online Intergenerational Co-parenting Program for Father-mother-grandmother Triad on the Intergenerational Co-parenting Relationship in the Perinatal Period
- ClinicalTrials.gov ID
- NCT05119062
- Acronym / sponsor ID
- HSEARS20210927005
- Conditions
- Intergenerational Relations, Perinatal Depression, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Maternity & Child Healthcare Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 12 Nov 2021 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Usual careParticipants in the control group will receive usual care. |
| an online intergenerational co-parenting programme | Experimental | Other: an online intergenerational co-parenting programme+usual careThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Intergeneration coparenting families will be excluded if members of the family unit with reported mental health problems, such as schizophrenia, bipolar affective disorders, etc.
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 |
|---|---|---|
| Usual careFamilies 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. | Other | Control group |
| an online intergenerational co-parenting programme+usual careThe 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. | Other | an online intergenerational co-parenting programme |
Primary outcome
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.
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.
12 secondary outcomes
The depressive symptoms of co-parenting members
Time frame: baseline at around 33-35 weeks gestation
The depressive symptoms of co-parenting members
Time frame: 6 weeks postpartum
The depressive symptoms of co-parenting members
Time frame: 3 months postpartum
The perceived stress of co-parenting members
Time frame: baseline at around 33-35 weeks gestation
The perceived stress of co-parenting members
Time frame: 6 weeks postpartum
The perceived stress of co-parenting members
Time frame: 3 months postpartum
Co-parenting relationship between couples
Time frame: 6 weeks postpartum
Co-parenting relationship between couples
Time frame: 3 months postpartum
Parenting stress of parents
Time frame: 6 weeks postpartum
Parenting stress of parents
Time frame: 3 months postpartum
Parenting self-efficacy of parents
Time frame: 6 weeks postpartum
Parenting self-efficacy of parents
Time frame: 3 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- BackgroundAbidin, R. R., & Abidin, R. R. (1990). Parenting Stress Index (PSI)(p. 100).
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 23166477Feinberg 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.
- BackgroundGibaud-Wallston, J., & Wandersman, L. (2001). Parenting sense of competence scale (PSOC).
- BackgroundLi, 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.
- BackgroundRadloff, 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.
- BackgroundWu, 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: PubMed 21790741Liu 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.
- Background: PubMed 17846556Ngai 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.
- Background: PubMed 16219957Leung 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.
- Individual participant dataSharing planned: No
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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.
Ngai Feiwan, PhD principal investigator
School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intergenerational Relations and Perinatal Depression, run by The Hong Kong Polytechnic University at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intergenerational co-parenting relationship (time frame: 6 weeks postpartum). The study lists 2 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 NCT05119062, which also lists 10 linked publications.
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 25 May 2022.