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Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide

Genetic Counseling to Support Couples' Decision-Making Regarding Prenatal Testing: A Randomized Controlled Trial Using the Ottawa Decision Guide - COUPLE-DECIDE RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059478
Enrollment
80
Registered
2025-10-20
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Couples without children

Interventions

The intervention group will receive support for couples&#39
decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide. The intervention group will receive sup
decision-making using the Ottawa Decision Support Guide. The control group will receive decision-making support without using the Ottawa Decision Support Guide.

Sponsors

Nagasaki University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged 18 years or older Couples without children Wife under 50 years of age Couples married for 10 years or less

Exclusion criteria

Exclusion criteria: Couples who have children Individuals who have experienced fertility treatment Those who have previously received genetic counseling related to NIPT Individuals who are unable to participate in the study online (e.g., cannot access Zoom or complete web-based questionnaires)

Design outcomes

Primary

MeasureTime frame
Couples' communication attitudes will be assessed using the Japanese version of the CPQ, with particular focus on the scores for "mutually constructive" and "constructive communication." These scores will be compared between the intervention and control groups. Participants will complete the Japanese CPQ at study enrollment, immediately after the intervention, and one month after the intervention.

Secondary

MeasureTime frame
Study participants will complete the Decisional Conflict Scale (DCS) immediately after the intervention. Scores on the DCS will be compared between the intervention and control groups.

Countries

Japan

Contacts

Public ContactMikako Miyata

Department of Nursing Science, Graduate School of Biomedical Sciences, Nagasaki University Doctoral Program, Department of Nursing Science

bb55319028@ms.nagasaki-u.ac.jp095-819-7907

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026