Меню
Набор по приглашению NCT06105905

Latino Teen Pregnancy Prevention K23

Без фазы С лечением Pregnancy in Adolescence Rural Health Hispanic or Latino

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: Healthy futures ("Futuros Saludables").
Кому может быть актуально
Состояния в реестре: Pregnancy in Adolescence, Rural Health, Hispanic or Latino. Базовые параметры: 14 лет — 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Reducing Reproductive Health Disparities Among Latino Youth Living in Rural Communities

Обзор

The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.

Подробное описание

The study uses questionnaires and interviews with youth and community members, to co-develop and pilot test an unintended teen pregnancy prevention intervention in an emerging immigrant Latino rural community, aiming to decrease reproductive health disparities in marginalized communities across the country. To achieve this objective, the team will conduct interviews and co-development sessions, to ensure input from key stakeholders in the community, when developing an intervention.

Delineation of Activities:

Research Activities

• Aim 1: Through stakeholder-engaged research, the team will identify key factors (at multiple levels of influence as defined by NIMHD) needed for the co-development of an acceptable and effective teen pregnancy prevention intervention for rural Latino teens: The team will conduct up to 60 key informant interviews to identify barriers to and facilitators of teen pregnancy prevention programming, such as cultural and social norms. Participants will complete a survey to collect demographic data before participating in the interview. Interviews will last 45 to 60 minutes, in either Spanish or English depending on participants' preference, and will be done using video conference tools at the interviewee's location and times of preference to accommodate participants' schedules.

• Aim 2: Using the transcreation framework, co-develop with community partners a teen pregnancy prevention intervention that best fits the community's unique needs and context: Up to 50 key stakeholders will participate in approximately 8 co-development hybrid sessions to discuss, draft, and redraft each module of the Cuidate intervention syllabus, interactive course materials, and activities. The goal of the workgroup is to discuss recommendations and unique needs of local Latino teens (Specific Aim 1) and modify Cuidate in response to local insights. These sessions will be facilitated by the study research team in either Spanish or English depending on the participants' preference. The sessions will be done using a hybrid method that could include in-person interactions and/or video conference tools at the interviewee's location and times of preference to accommodate participants' schedules. Virtual co-development sessions will be conducted via Microsoft Teams. University of Kansas (KU) will utilize Zoom as an alternative option for virtual meetings. In that instance, KU will initiate the Zoom call. In-person, interviews may be conducted at a local church, and/or at a location managed by a Juntos Community Health Specialists.

• Aim 3: Conduct a pilot study to evaluate the feasibility of a co-created teen pregnancy prevention intervention in target Latino rural communities: The co-developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and parent/guardian(s). Feedback on delivery mode (virtual, in-person, or hybrid) will be elicited during the co-development sessions. If in-person/hybrid is suggested, information will be collected about preferred location (e.g., a local community center, sports club, etc.). Participants will complete sessions, in either Spanish or English depending on participants' preference, using video conference tools. After the delivery of the intervention, facilitators will take field notes and complete a debriefing questionnaire to assess practicality and fidelity. Teens and parent/guardian(s) will complete a 20-minute survey pre-intervention, immediately post-intervention, three-month post-intervention, six-month post-intervention, and twelve-month post-intervention (computer-assisted, self-administered, online via Research Electronic Data Capture - REDCap). Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability. Surveys will be de-identified; participants will create a code to match surveys without using identifying data.

Those currently enrolled are only from non-trial aims in this module.

Вмешательства

  • Поведенческое Healthy futures ("Futuros Saludables")
    The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and parent/guardian(s). Feedback on delivery mode (virtual, in-person, or hybrid) during the co-development sessions. If in-person/hybrid is suggested, feedback will be elicited about preferred location (e.g., a local community center, sports club, etc.). Participants will complete sessions, in either Spanish or English depending on participants' preference, using video conference tools.

Первичные конечные точки

  • A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale. [Срок оценки: Immediately after intervention]
  • A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale. [Срок оценки: Immediately after intervention.]
  • A survey to determine the facilitators perception of the difficulty of implementing the intervention. [Срок оценки: Facilitator surveys will occur immediately post intervention. Field notes will be collected during the delivery of the intervention.]
Вторичные конечные точки (10)
  • A survey analysis of teen sexual behavior risk pre and post intervention. [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • A survey analysis of teen sexual intention pre and post intervention. [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Pregnancy risk/prevention self-efficacy [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Cultural Pride [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • For teens Healthy Relationships [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • For Adults difficult conversations [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Family Connections [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Communication [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Mental health: Parent Adolescent Communication scale [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]
  • Health care utilization and access [Срок оценки: Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention]

Критерии участия

Критерии включения

  • 14-18 years old,
  • speak English or Spanish,
  • Parents/LARs.

Критерии исключения

  • non-English or non-Spanish speaking
  • developmental delayed
  • have significant behavioral health issues which may interfere with study participation
  • incarcerated minors
  • minors in foster care.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Childrens Mercy Hospital and Clinics — Kansas City

Идентификаторы

NCT: NCT06105905 · STUDY00002128 · 1K23HD109464-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗