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临床试验/NCT06105905
NCT06105905已完成不适用

Reducing Reproductive Health Disparities Among Latino Youth Living in Rural Communities

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
2
主要终点
A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

One arm pilot trial

Experimental

The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and parent/guardian(s). Feedback will be elicited 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.). Sessions will be hosted in either Spanish or English depending on participants' preference, using video conference tools. Teens and parent/guardian(s) will complete a 20-minute survey pre-intervention, immediately after the 8 session intervention, three-month post-intervention, six-month post-intervention, and twelve-month post-intervention. Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability.

干预措施: Healthy futures ("Futuros Saludables") (Behavioral)

结局指标

主要结局

A survey analysis of participant degree of acceptance of conducted intervention using a Likert Scale.

时间窗: Immediately after intervention

This outcome measure identifies the degree in which the intervention is accepted by the participant. Acceptability refers to the extent at which the intervention is perceived as agreeable, or satisfactory to the participant. Acceptability is measured using a Likert Scale in a survey immediately after the 8 session intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention Meets my approval, 2) Newly Approved Intervention is appealing to me, 3) I like the Newly Approved Intervention, 4) I welcome the Newly Approved Intervention.

A survey to determine the participants perception of intervention applicability of conducted intervention using a Likert Scale.

时间窗: Immediately after intervention.

This outcome measure identifies the extent in which a participant assesses the appropriateness of the conducted intervention. Appropriateness refers to the perceived ft, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and/or perceived ft of the innovation to address a particular issue or problem. Appropriateness is measured using a Likert Scale in a survey immediately after the 2-day intervention is administered. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems fitting, 2) Newly Approved Intervention seems suitable, 3) Newly Approved Intervention seems applicable, 4) Newly Approved Intervention seems like a good match.

A survey to determine the facilitators perception of the difficulty of implementing the intervention.

时间窗: Facilitator surveys will occur immediately post intervention. Field notes will be collected during the delivery of the intervention.

This outcome measure identifies the feasibility for facilitators to conduct the intervention. Feasibility refers to the extent to which an innovation "can be success- fully used or carried out within a given agency or setting". Feasibility will be measured using the facilitator survey that employs a Likert Scale. The Likert Scale ranges from 1-4: 1) Newly Approved Intervention seems implementable, 2) Newly Approved Intervention seems doable, 3) Newly Approved seems easy to use. Feasibility will also be measured using ethnographic field notes that are analyzed using inductively using a grounded theory approach. Weekly meetings will allow for resolution of discrepancies and to establish inter-rater reliability.

次要结局

  • A survey analysis of teen sexual behavior risk pre and post intervention.(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.(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • Pregnancy risk/prevention self-efficacy(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • Cultural Pride(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • For teens Healthy Relationships(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • For Adults difficult conversations(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • Family Connections(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • Communication(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(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)
  • Health care utilization and access(Average of 20-minute survey pre-intervention, immediately after intervention, three-month, six-month, and twelve-month post-intervention)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Romina Barral

Associate Professor of Pediatrics, UMKC School of Medicine; Research Assistant Professor of Pediatrics, University of Kansas Medical Center; Faculty, Division of Adolescent Medicine, Children's Mercy Hospital Kansas City

Children's Mercy Hospital Kansas City

研究点 (2)

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