Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062245) titled 'Development and effects of an intervention programme co-parenting and prevent postpartum depression: A randomised controlled trial' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Tokushima University
Condition:
Condition - Postpartum depression
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study was to promote co-parenting among expectant mothers and fathers by promoting communication in child-rearing and to examine the effects of this intervention program, including its impact on mental health.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Pregnancy Based Coparenting Promotion Program Participants received the Pregnancy Based Coparenting Promotion Program in addition to usual antenatal care. The program consisted of an educational booklet for expectant fathers and mothers, providing information on postpartum maternal physical and psychological changes, infant care, communication between partners, and sharing of parenting and household responsibilities. Participants were encouraged to use the booklet together during pregnancy.
Interventions/Control_2 - Participants received routine antenatal care provided by the study institutions.No additional coparenting educational program or study specific intervention was provided.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The study was conducted at a general hospital with consent to participate, targeting pregnant women aged 20 or older who were planning to give birth and their husbands. As the study required respondents to answer questionnaires and communicate with midwives, participants were limited to those who could communicate in Japanese.
Key exclusion criteria - Minors and those requiring a proxy were excluded.
Target Size - 112
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2022 Year 06 Month 01 Day
Date of IRB - 2022 Year 10 Month 19 Day
Anticipated trial start date - 2022 Year 10 Month 25 Day
Last follow-up date - 2023 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067050
Disclaimer: Curated by HT Syndication.