Clinical trial NCT05119062: The Feasibility of an Online Intergenerational Co-parenting Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intergenerational Relations
Perinatal Depression
Parenting
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Shenzhen Maternity & Child Healthcare Hospital
First posted: 2021-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: intergenerational co-parenting relationship
timeFrame: 6 weeks postpartum
measure: intergenerational co-parenting relationship
timeFrame: 3 months postpartum
Secondary outcomes:
measure: The depressive symptoms of co-parenting members
timeFrame: baseline at around 33-35 weeks gestation
measure: The depressive symptoms of co-parenting members
timeFrame: 6 weeks postpartum
measure: The depressive symptoms of co-parenting members
timeFrame: 3 months postpartum
measure: The perceived stress of co-parenting members
timeFrame: baseline at around 33-35 weeks gestation
measure: The perceived stress of co-parenting members
timeFrame: 6 weeks postpartum
measure: The perceived stress of co-parenting members
timeFrame: 3 months postpartum
measure: Co-parenting relationship between couples
timeFrame: 6 weeks postpartum
measure: Co-parenting relationship between couples
timeFrame: 3 months postpartum
measure: Parenting stress of parents
timeFrame: 6 weeks postpartum
measure: Parenting stress of parents
timeFrame: 3 months postpartum
measure: Parenting self-efficacy of parents
timeFrame: 6 weeks postpartum
measure: Parenting self-efficacy of parents
timeFrame: 3 months postpartum
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Maternity & Child Healthcare Hospital
state: Guangdong
city: Hong Kong
country: China
facility: Hong Kong Polytechnic University
Study officials:
affiliation: School of Nursing
name: Ngai Feiwan, PhD
role: PRINCIPAL_INVESTIGATOR
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