A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)
A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)
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.
MyGENESIS-PATH is a structured, self-guided digital psychoeducational intervention developed as part of the MyGENESIS project. Its development was informed by existing evidence, psychological theory, qualitative and quantitative research with donor-conceived people, and consultation with people with lived experience and relevant professional expertise.
Before the randomized trial, a separate alpha-testing phase will be conducted with donor-conceived adults and expert reviewers to identify major problems relating to comprehensibility, relevance, emotional safety, usability, and technical functioning. Participants involved in alpha testing will not be eligible for the randomized pilot trial.
The registered study is a two-arm, parallel-group randomized pilot and feasibility trial involving 60 donor-conceived adults. After providing informed consent and completing the baseline questionnaire, participants will be randomized automatically within LimeSurvey in a 1:1 ratio to immediate access to MyGENESIS-PATH or to a waitlist control condition.
Participants allocated to the intervention group will receive access to MyGENESIS-PATH. The intervention comprises six psychoeducational modules, reflective activities, brief self-assessment check-ins, tailored pathways, and conditional coping exercises. Its content addresses:
donor-conception-related information and legal contexts; DNA testing and associated decisions and experiences; donor conception and identity; expectations concerning donors and donor siblings; family relationships, disclosure, support, and stigma; and integration, coping, psychological well-being, and support resources.
Brief check-ins embedded within the intervention are used to tailor coping content to participants' current experiences. Depending on participants' responses, they may receive no additional coping content, a moderate-support exercise, or an elevated-support exercise. Only one level of support is presented for each assessed domain.
Participants will be encouraged to complete the intervention within the access period. Immediately after reaching the end of the intervention, they will be invited to complete a brief feedback questionnaire assessing acceptability, usability, usefulness, relevance, emotional manageability, technical problems, and potential unwanted effects.
Participants allocated to the waitlist control group will not receive access to MyGENESIS-PATH during the initial study period. Both groups will complete psychosocial outcome assessments at baseline and 4 weeks after randomization. Waitlist participants will be offered access to MyGENESIS-PATH after completing the 4-week follow-up assessment.
The study will primarily assess the feasibility and acceptability of recruitment, randomization, intervention delivery and use, immediate feedback collection, participant follow-up, and psychosocial outcome-data collection. Psychological outcomes will be examined descriptively and exploratorily to assess their suitability, variability, and potential responsiveness for a future definitive trial.
Inclusion Criteria:
Exclusion Criteria:
mmartins@fpce.up.pt+351 220 400 667
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