Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062408) titled 'Factors Associated with Maternal-Infant Bonding in Pregnant and Postpartum Women Receiving Psychiatric Care and the Effects of Newborn Behavioral Observations (NBO) Intervention' on July 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Ehime University Hospital

Condition: Condition - Psychiatric disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate factors associated with impaired maternal-infant bonding, including childhood trauma, social cognitive functioning, autism spectrum disorder (ASD) traits, lifestyle factors such as screen time, partner-related factors, and ASD traits in the infant. To evaluate the effects of the Newborn Behavioral Observations (NBO) intervention on maternal-infant bonding and infant social development. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants receive the Newborn Behavioral Observations (NBO) intervention in addition to usual psychiatric care. Interventions/Control_2 - Participants receive usual psychiatric care without the NBO intervention.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Pregnant women aged 18 years or older who received psychiatric care at our hospital during the study period, their spouses or partners, and their infants. Key exclusion criteria - Patients who did not provide informed consent, those deemed unsuitable for participation by the attending physician, and mothers younger than 18 years of age and their spouses or partners. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 27 Day Date of IRB - 2026 Year 07 Month 27 Day Anticipated trial start date - 2026 Year 07 Month 31 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071420

Disclaimer: Curated by HT Syndication.