A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study. Participants will know whether they have immediate access to MyGENESIS-PATH. The research team will also have access to group allocation where required for intervention administration and follow-up. Outcomes will be assessed using self-administered online questionnaires. No blinded outcome assessor is involved.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Donor-conceived people
- •Aged 18 or over
- •Able to read and understand English
- •Provide informed consent
排除标准
- •Previous participation in the MyGENESIS-PATH alpha-testing phase
- •Unable to provide informed consent
- •Unable to complete the online study procedures
研究组 & 干预措施
MyGENESIS Intervention
Participants randomized to this arm receive access to the MyGENESIS digital psychoeducational program, consisting of six sequential self-guided online modules.
干预措施: MyGENESIS Digital Psychoeducational Program (Behavioral)
Waitlist Control Group
Participants in this arm do not receive access to the MyGENESIS intervention during the study period and are offered access after completion of post-test assessments.
结局指标
主要结局
Perceived stress
时间窗: Baseline (pre-intervention) and 4 weeks post-randomization
Change in perceived stress (PSS-4) total score (range 0-40, higher scores indicating greater perceived stress)
Completion of the 4-week follow-up assessment
时间窗: 4 weeks after randomization
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.
Recruitment feasibility
时间窗: From recruitment opening to completion of recruitment, anticipated to be approximately 3 months
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.
Acceptability of MyGENESIS-PATH
时间窗: Immediately after completing the intervention.
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.
stress
时间窗: Baseline (pre-intervention) and 4 weeks post-randomization
Change in perceived stress as measured by the Perceived Stress Scale (PSS-10) total score
次要结局
- Coping(Baseline (pre-intervention) and 4 weeks post-randomization)
- Donor-conception identity(Baseline (pre-intervention) and 4 weeks post-randomization)
- Psychological well-being(Baseline (pre-intervention) and 4 weeks post-randomization)
- Perceived stress(Baseline (pre-intervention) and 4 weeks post-randomization)
- coping(Baseline (pre-intervention) and 4 weeks post-randomization)
- donor-conceived related identity(Baseline (pre-intervention) and 4 weeks post-randomization)
研究者
Mariana Veloso Martins
Assistant Professor
Universidade do Porto