跳至主要内容
临床试验/NCT07203612
NCT07203612招募中不适用

Prevention of Injuries Among Young Children: Tailoring a Home Supervision Intervention for Latinx Caregivers

Western Michigan University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Supervision Behavior

研究概览

简要总结

The aim of the proposed study is to create and test a modified version of the SHS intervention for Latinx families in Southwest Michigan. We will partner with three nearby Latinx resource centers in addition to a Head Start program that provides preschool to a large number of Latinx families. The project will use an iterative approach to modifying the intervention and will occur in five steps. In step 1, we will conduct focus groups with caregivers and staff from the 3 Latinx resource centers to identify changes to make to the intervention materials. In step 2, we will make modifications to the program materials. In step 3, we will conduct additional focus groups to seek feedback about the revised program materials. In step 4, we will pilot test the revised program materials, and in step 5 we will conduct the RCT of the modified program materials with caregivers of children ages 2-5. We will examine the effect of the modified intervention on caregivers' supervision of their children (using self-reports and observations) and on children's minor injury frequency.

详细描述

3. APPROACH 3.1 Procedures. The SHS program will be extended to a Latinx population using procedures established by the Centers for Disease Control and Prevention and known as the Map of Adaptation Process. Although there is much diversity within Latinx cultures, the large majority of Latinx families living in Southwest Michigan are of Mexican heritage. Thus, our adaptations will reflect the culture and language of families from Mexico and Central America. The adaptation process emphasizes the need to maintain fidelity of the core elements of an evidence-based intervention like SHS while increasing its relevance (i.e., tailoring it) for a new population. This is achieved by following several steps, which will guide the present study. These steps include: (a) assess the target population's needs (established already by the literature); (b) select an intervention to address those needs (SHS program); (c) prepare the intervention for adaptation (steps 1-3 - see below); and (d) pilot and test the intervention (steps 4-5 below).

Thus, our study will involve an iterative process including five steps. In step 1 we will translate intervention materials (written materials and videos) and conduct focus groups with Latinx caregivers from the community and staff from three Latinx resource centers to identify modifications to be made to program materials. In step 2, the investigators will modify the intervention and video materials based on these focus group data. The investigators anticipate that this step will include making new program videos depicting local Spanish speaking families. The investigators will also make a new introductory video to feature a Spanish speaking narrator. In step 3, the investigators will conduct additional focus groups with Latinx caregivers and center staff using the modified intervention content and make additional changes to the materials if needed. In step 4, the investigators will pilot test the modified intervention with a small group of caregivers and make final modifications. In step 5, the investigators will conduct an RCT to test the modified intervention, including its impact on caregivers' supervision practices and children's injury frequency.

Local Latinx Resource Centers. The investigators will partner with three nearby agencies serving Latinx families: El Concilio (Kalamazoo), Voces (Battle Creek, 30 miles away from campus), and the Hispanic Center of West Michigan (Grand Rapids, 53 miles away). Each agency provides services for Latinx members of their respective communities, including professional translation and interpretation services, liaison services (between families and schools), support regarding immigration and legal issues, assistance accessing resources (e.g., Medicaid, food stamps), youth programs, English as a second language courses, adult education, workforce development and vocational training, and GED classes. Combined, the three Latinx community centers serve approximately 16,000 individuals per year. The Latinx population of each community is as follows: Kalamazoo (5.2%); Battle Creek (7.5%); and Grand Rapids (16.1%; US Census Bureau, 2019).

Head Start. The investigators will also recruit Latinx families from Kent County Head Start. The investigators have successfully collaborated with Kent County Head Start in past research. Head Start is a national program that provides free preschool for l0w-income families of children ages 3-5. The program focuses on kindergarten readiness and also typically provides additional supports for families, such as parental education and linkage to community resources. Kent County Head Start serves approximately 1500 children per year; 30% (450) of these children are Latinx.

Step One: In step 1, the investigators will identify modifications that need to be made to the SHS intervention by conducting 1.5 hour focus groups with both Latinx caregivers of young children (ages 2-5) as well as a focus group with staff from the three Latinx resource centers. Based on recommended sample sizes for focus group research, the investigators will present the SHS materials to Latinx caregivers in three in-person focus groups of 6-8 participants. The investigators will conduct one focus group in each of the Latinx centers from which the investigators will be recruiting (Kalamazoo, Battle Creek, and Grand Rapids). The investigators will conduct one additional focus group including 2-3 agency staff from each of the 3 Latinx serving centers. The investigators will use the SHS materials that have been modified to be appropriate for low-income families from Dr. Damashek's current R15. For these focus groups, the investigators will make preliminary changes to program materials (to make them suitable for the focus group) by translating written materials into Spanish, dubbing video materials to have Spanish voices, and translating subtitles on the videos into Spanish; Morrongiello and her graduate student will make video modifications. Professional translations will be conducted by certified translators at the Latinx resource center in Kalamazoo. Caregiver and staff focus groups will be facilitated by a bilingual RA, in combination with Dr. Damashek. Focus groups will be video recorded and transcribed by a bilingual RA. Transcriptions will be translated into English by a certified translator and will be coded by Drs. Damashek and Morrongiello and URA's to identify themes (i.e., aspects that were helpful about the materials and aspects that need to be changed).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Spanish speaking caregiver of child ages 15 months to 5 years old.

排除标准

  • child of caregiver has pervasive develomental disorder, is blink, or deaf.

结局指标

主要结局

Supervision Behavior

时间窗: baseline, immediate post-intervention, 1 month post-intervention

Caregivers will complete the Computerized Supervision Observation Measure (CSOM), which is a 20-minute observational measure of supervision that was created by Dr. Morrongiello (Morrongiello et al., 2010). The measure assesses the frequency with which caregivers verbally intervene to address risky child behavior (e.g., climbing on a dresser) as well as the type of verbal comment that they make (e.g., prohibitions, directives, or teaching comments). Each parent will view a videotape of a young child (same sex as their own) in a naturalistic home setting. The video will show a child moving throughout the home playing in different areas (living room, kitchen). Parent responses will be coded to rate the degree to which they respond effectively to children' engagement in risky behavior. Coding categories include: prohibitions or threats (e.g., don't do that"), directions or control statements (e.g., "you can put that over there") and teaching/explanations (e.g., "that's hot).

Parent Supervision Attributes Profile Questionnaire (PSAPQ)

时间窗: baseline, immediately post-intervention, 1 month post intervention

The PSAPQ will be administered at baseline, immediately post-intervention, and at 1 month post-intervention. The PSAPQ is a measure of parents' supervision practices and beliefs (Morrongiello \& Corbett, 2006; Morrongiello \& House, 2004). It is comprised of 29 items organized into 4 subscales (protectiveness, supervision, tolerance for risk taking, and belief that fate determines a child's injury risk). Caregivers use a 5-point Likert scale (1= strongly disagree, 5 = strongly agree) to rate the extent to which they agree with items assessing their supervision attitudes and behaviors (e.g., I let my child take some chances in what he/she does; I have my child within reach at all times). The minimum score on the scale is 29, and the maximum score is 145. Higher scores indicate engagement in higher levels of supervision and greater beliefs about the importance of protecting children from injuries.

次要结局

  • Injury Frequency Interview(baseline, immediately post-intervention, 1 month post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Damashek

Principal Investigator

Western Michigan University

研究点 (2)

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