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Идёт набор NCT06990724

Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents.

Без фазы С лечением Contraceptive Usage Contraception Behavior

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: Videogame Intervention, Commercial game control.
Кому может быть актуально
Состояния в реестре: Contraceptive Usage, Contraception Behavior. Базовые параметры: 15 лет — 20 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents: A Randomized Trial

Обзор

The purpose of this study is to evaluate the effectiveness of a videogame compared to an attention/time control at reducing contraceptive non-use among adolescents.

Вмешательства

  • Другое Videogame Intervention
    No Baby No video game
  • Другое Commercial game control
    Commercial video game

Первичные конечные точки

  • Change in mean frequency of participants' contraception non-use over the last 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in mean frequency of participants' contraception non-use at last sexual encounter. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' use of different types of contraception over the last 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' use of different types of contraception at last sexual encounter. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in number of participants abstaining from having sex over the last 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the mean number of sexual encounters over the last 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the mean number of sexual partners over the last 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the number of participants who use alcohol and/or take drugs before sex at last sexual encounter. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the number of participants with a positive STI (Sexually Transmitted infection) test result. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in the number of participants with a positive pregnancy test result for themselves or a partner. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
Вторичные конечные точки (12)
  • Change in participants' intentions for contraception non-use over the next year, as indicated by participants' mean responses to a survey question. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' self-efficacy regarding condom use, as indicated by their mean rating on a survey question. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' self-efficacy regarding contraception use, as indicated by their mean ratings on a survey question. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' perceptions of sexual risk (susceptibility to getting an STI), as indicated by their mean rating on a survey question. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' perceptions of sexual risk (getting pregnant/getting a partner pregnant), as indicated by their mean rating on a survey question. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Change in participants' sexual knowledge, as reflected by their mean scores on a sexual knowledge questionnaire. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • A change in the number of participants who visit a clinic to obtain contraception or to undergo sexually transmitted infection (STI) screening over the past 3 months. [Срок оценки: Baseline, 3-month follow-up, 9-month follow-up.]
  • Assessment of the fidelity of program delivery based on duration of No Baby No game play. [Срок оценки: Baseline]
  • Assessment of the fidelity of program delivery based on number of interruptions to No Baby No game play. [Срок оценки: Baseline]
  • Assessment of the quality of No Baby No program delivery, as indicated by the average number of technological failures during the game-play experience. [Срок оценки: Baseline]
  • Assessment of the quality of No Baby No program delivery, as measured by the average number of minutes of game play. [Срок оценки: Baseline]
  • Assessment of the quality of No Baby No program delivery, as measured by the average number of game play sessions attended by participants. [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Male or Female
  • Age15-20 at the time of enrollment
  • Able to speak and read English or Spanish
  • Have a smart phone (to scan QR code) or personal email account (to take screening questionnaire)

Критерии исключения

  • Age less than 15 or older than 20
  • Unable to speak and read English or Spanish
  • Do not have a smart phone or personal email account

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
Лечение

Центры проведения

США · 7 центров
  • Sesame Flyers International Inc. — Brooklyn
  • El Barrio Operation Fightback — New York
  • King of Kings Foundation — Queens
  • New York Center for Interpersonal Development (NYCID) — Staten Island
  • Bronx Health Link — The Bronx
  • ASPIRA — The Bronx
  • Destination Tomorrow — The Bronx

Идентификаторы

NCT: NCT06990724 · 24-11028189 · TP2AH000081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗