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MyGENESIS-PATH: Digital Program for Donor-Conceived People

ConditionPsychosocial Stress
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade do Porto

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Donor-conceived people

Aged 18 or over

Able to read and understand English

Provide informed consent

Disqualifiers

Previous participation in the MyGENESIS-PATH alpha-testing phase

Unable to provide informed consent

Unable to complete the online study procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • MyGENESIS Digital Psychoeducational Program

    Behavioral

    A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MyGENESIS InterventionExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment feasibility

Number of eligible participants who provide informed consent, complete the baseline questionnaire, and are randomized during the planned recruitment period. The recruitment target is 60 randomized participants within the planned recruitment period. The number screened, number eligible, number consenting, number completing baseline, and mean number randomized per month will also be reported.

Time frame
From recruitment opening to completion of recruitment, anticipated to be approximately 3 months
2

Acceptability of MyGENESIS-PATH

Acceptability will be assessed immediately after intervention completion among participants allocated to MyGENESIS-PATH using participant ratings of perceived usefulness; perceived relevance; emotional manageability; willingness to recommend the intervention to another donor-conceived person. Acceptability will also be explored qualitatively through optional open-ended feedback.

Time frame
Immediately after completing the intervention.
3

Completion of the 4-week follow-up assessment

Percentage of all randomized participants who submit the 4-week follow-up questionnaire. The numerator will be the number of randomized participants submitting the follow-up questionnaire, and the denominator will be all randomized participants. A completion rate of at least 80% will support progression without major modification.

Time frame
4 weeks after randomization

Secondary outcomes

1

Perceived stress

Change in perceived stress as measured by the Perceived Stress Scale (PSS-4) total score (range 0-16), with higher scores indicating greater perceived stress.

Time frame
Baseline (pre-intervention) and 4 weeks post-randomization
2

Psychological well-being

Change in the WHO well-being index (WHO-5) total score (range 0-40, higher scores indicating greater well-being )

Time frame
Baseline (pre-intervention) and 4 weeks post-randomization
3

Coping

Change in coping responses as measured by the Brief COPE Inventory subscale scores (14 subscales, each ranging from 2-8, with higher scores indicating greater use of the respective coping strategy)

Time frame
Baseline (pre-intervention) and 4 weeks post-randomization
4

Donor-conception identity

Change in donor conception identity as measured by the Donor Conception Identity Questionnaire (DCIQ) subscale scores, including Concern and Preoccupation (range 8-40), Internalized Stigma (range 5-25), Pride and Acceptance (range 6-30), and Openness and Understanding (range 4-20) Higher scores indicate greater endorsement of the respective donor conception identity domain.

Time frame
Baseline (pre-intervention) and 4 weeks post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade do Porto

Lead sponsor

Fundação para a Ciência e a Tecnologia

Collaborator

Source ClinicalTrials.gov

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