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NCT07457697
MyGENESIS-PATH: Digital Program for Donor-Conceived People
Conditions: Psychosocial Stress
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Universidade do Porto
Location: Faculty of Psychology and Education Sciences, University of Porto Porto Porto District
Summary
MyGENESIS-PATH is a self-guided digital psychoeducational intervention designed to support donor-conceived adults in navigating donor-conception-related information and uncertainty, DNA testing, identity, family relationships, disclosure, stigma, and expectations concerning donors and donor siblings.
This two-arm randomized pilot and feasibility trial will evaluate the feasibility and acceptability of delivering MyGENESIS-PATH and of conducting a future definitive randomized controlled trial. Sixty donor-conceived adults will be randomly allocated in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control condition.
Primary feasibility outcomes will assess recruitment, completion of the 4-week follow-up assessment, completeness of psychosocial outcome data, intervention uptake and completion, and completion of the immediate post-intervention feedback assessment. Intervention acceptability, usability, perceived usefulness, relevance, emotional manageability, and potential unwanted effects will be assessed among participants allocated to MyGENESIS-PATH.
Changes in perceived stress, psychological well-being, coping, and donor-conception-related identity from baseline to 4 weeks after randomization will be examined as exploratory outcomes. The study is not powered to detect definitive intervention effects.
Eligibility Criteria
Inclusion Criteria:
* Donor-conceived people
* Aged 18 or over
* Able to read and understand English
* Provide informed consent
Exclusion Criteria:
* Previous participation in the MyGENESIS-PATH alpha-testing phase
* Unable to provide informed consent
* Unable to complete the online study procedures
Source: ClinicalTrials.gov (NCT07457697). StuddyBuddy aggregates publicly available trial information.