Меню
Набор скоро начнётся NCT07457697

MyGENESIS-PATH: Digital Program for Donor-Conceived People

Без фазы С лечением Psychosocial Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MyGENESIS Digital Psychoeducational Program.
Кому может быть актуально
Состояния в реестре: Psychosocial Stress. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized Pilot and Feasibility Trial of a Digital Psychoeducational Intervention for Donor-Conceived Adults (MyGENESIS-PATH)

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое MyGENESIS Digital Psychoeducational Program
    A self-guided digital psychoeducational intervention based on cognitive-behavioral principles and the transactional model of stress.

Первичные конечные точки

  • Recruitment feasibility [Срок оценки: From recruitment opening to completion of recruitment, anticipated to be approximately 3 months]
  • Acceptability of MyGENESIS-PATH [Срок оценки: Immediately after completing the intervention.]
  • Completion of the 4-week follow-up assessment [Срок оценки: 4 weeks after randomization]
Вторичные конечные точки (3)
  • Psychological well-being [Срок оценки: Baseline (pre-intervention) and 4 weeks post-randomization]
  • Coping [Срок оценки: Baseline (pre-intervention) and 4 weeks post-randomization]
  • Donor-conception identity [Срок оценки: Baseline (pre-intervention) and 4 weeks post-randomization]

Критерии участия

Критерии включения

  • Donor-conceived people
  • Aged 18 or over
  • Able to read and understand English
  • Provide informed consent

Критерии исключения

  • Previous participation in the MyGENESIS-PATH alpha-testing phase
  • Unable to provide informed consent
  • Unable to complete the online study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Португалия · 1 центр
  • Faculty of Psychology and Education Sciences, University of Porto — Porto

Идентификаторы

NCT: NCT07457697 · 2023.14465.PEX · 2023.14465.PEX

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗