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临床试验/NCT03499405
NCT03499405已完成不适用

CIN001-HeadStart Navigator Intervention

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年8月1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
入组人数
36
试验地点
2
主要终点
Proportion of children who complete developmental testing guided by family navigators (feasibility).

研究概览

简要总结

Headstart (HS) is an early childhood education program for low-income children. Preliminary analyses of Hamilton County HS preschoolers with developmental concerns identified 26% with "severe concern" necessitating developmental testing, and only 47% followed-through when some developmental concern was identified. Those less likely to follow-through were African American or Hispanic, lived in larger families, or had asthma. Cultural and economic factors are known barriers to earlier diagnosis of children with developmental disabilities (DD) among African American, Hispanic and low-income children. Given that HS children are low-income and culturally diverse, preschoolers are likely to face barriers to early identification of DD and subsequently kindergarten readiness. Patient navigator programs are effective interventions for vulnerable populations to improve health care access, increase treatment adherence, enhance trust in health care systems, and reduce health care costs. A family (FN) intervention that is culturally-adapted to promote caregiver follow-through, and undergirded by HS's mission of kindergarten success may effectively increase caregiver adherence to developmental testing. The goal of this study is to develop and pilot test a FN intervention in HS that is executed by peer-to-peer navigators to improve adherence with developmental testing in high-risk preschoolers.

详细描述

Headstart (HS) is a pipeline for early school success for low-income children aged 3-5 years, and provides health promotion services such as developmental monitoring to promote school readiness. In 2014-2015 Hamilton County Headstart (HCHS) identified 968 of 2987 preschoolers (32%) with developmental concern, with 251 (26%) identified as "severe concern" necessitating developmental testing. Yet, follow-through with testing did not occur for 53 high-risk preschoolers (21%), and only 451 (47%) followed-through when some developmental concern was identified. Those less likely to follow-through were African American or Hispanic, lived in families of 3 or more, or had asthma. That race and ethnicity predict insufficient follow-through is not surprising; cultural and economic factors are known barriers to earlier diagnosis of children with developmental disabilities (DD), resulting in 2 year lags in obtaining DD diagnoses among African American, Hispanic and low-income children and placing them at risk for worse long-term prognosis. Diagnostic disparities are also grounded in the social factors of poorer health care access, caregiver distrust of health systems, knowledge deficits, and stigma about disability. One mechanism thought to contribute to the diagnostic delays is caregiver postponement in obtaining developmental assessments due to these collective factors. Given that all HS children are low-income and a majority are African American or Hispanic, HS preschoolers are likely to face barriers to early identification of DD and subsequently kindergarten readiness. An intervention that addresses the salient barriers to developmental assessment for HS preschoolers could advance pre-academic abilities and promote access to earlier recognition and treatment of DD, leading to improved health outcomes.

Patient navigator programs have been effective interventions for vulnerable populations to improve health care access, increase treatment adherence, enhance trust in health care systems, and reduce health care costs. Despite these findings, investigations into peer-based navigation interventions for families of children with inferior health outcomes have mostly been program evaluations or unpublished clinical trials. A promising study in Developmental and Behavioral Pediatrics (DBP) on family navigators (FN) for children referred from primary care for evaluation of DD is examining family quality of life outcomes prior to and after DD diagnoses, and has shown preliminary success in developing and training FNs. A FN intervention that is culturally-adapted to promote caregiver follow-through, and undergirded by HS's mission of kindergarten readiness may effectively increase caregiver adherence to developmental testing in HS. The goal of this study is to refine and pilot test a FN intervention that is informed by HS caregivers, staff and primary care providers (PCP), grounded in the HS community, and executed by peer-to-peer navigators to improve adherence with developmental testing in high-risk preschoolers. This study is the final year of a research program that will focus on tailoring the elements of a community-based (Head Start (HS) Family Navigator (FN) intervention for high risk children with developmental concerns in order to improve access to developmental testing. This study will be conducted over a 1 year period with the specific aim outlined below.

The study titled: Prototype of a Head Start Navigator Intervention for Child Developmental Testing (IRB#2016-4253) was conducted to develop a community-based family navigator intervention for preschoolers identified in HS as high-risk for developmental delay. Focus groups were conducted with caregivers, teachers and primary care providers (PCPs) to understand the barriers and facilitators to follow-through with developmental testing. The prototype was tailored to the thematic focus group findings, cultural and risk factors previously identified, and results of an updated analysis of predictors of poor follow-through of developmental assessments from HCHS academic year 2015-2016 (IRB# 2016-4253). Findings confirmed that primary care and Head Start operate in silos regarding developmental screening and follow-through for at-risk children. Facilitating factors to caregiver follow-through were identified as: building relationships, increasing resource knowledge, and addressing denial/stigma of disability. Findings substantiated that caregivers needed assistance with navigating developmental testing, and valued its delivery using a peer-to-peer approach that was culturally-matched. The intervention was adapted from the crucial components necessary for a successful Family Navigator training program and delivery of the intervention including elements of frequency, duration and intensity that were also confirmed by the findings.

Materials and Methods

Study Purpose:

研究设计

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

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • FN participants will be current or former HS parents and sampled from urban and suburban HS.Eight FNs will be trained to support and guide caregivers through developmental testing, including 4 African American, 2 Caucasian and 2 bi-lingual Hispanic parents. Each FN will be assigned 1 to 4 caregivers.
  • The study sample of caregiver participants will include 32 eligible HS caregivers of preschoolers between 3 and 4 years old identified with moderate or severe developmental concerns on HS developmental screening, in order to include those at-risk before kindergarten age. Those with moderate developmental concern will have failed 2 domains on developmental screening, whereas those with severe concern have failed 3 or more domains. Those who fail 1 domain (mild concern) will be excluded since often single domain failures are due to limited early learning exposures and/or language barriers, which can be adequately addressed in HS.24,25 Half of those selected will be sampled from the moderate and half from the severe group, with 50% from urban and 50% from suburban HS centers included. Given that the demographics differ slightly in racial and ethnic make-up among the urban and suburban Head Starts, 12 African American, 2 Caucasian and 2 Hispanic caregivers will be sampled from urban HS; in suburban HS, 8 African American, 6 Caucasian and 2 Hispanic caregivers will be sampled.

排除标准

  • For FN, not being a former head start parent.
  • For caregiver, child not failing more than 2 or more domains on developmental testing.

研究组 & 干预措施

Intervention group

Experimental

Intervention group will receive a family navigator intervention from a culturally matched family navigator.

干预措施: Family Navigator Intervention (Behavioral)

Control group

No Intervention

Control group will not receive a family navigator intervention from a culturally matched family navigator.

结局指标

主要结局

Proportion of children who complete developmental testing guided by family navigators (feasibility).

时间窗: Up to three months.

The primary outcome is the proportion of children who complete referrals for developmental testing in the intervention group relative to the control group, with the hypothesis that the FN intervention will increase caregiver completion of referrals and time to completion is less than those in the control group (feasibility).

次要结局

  • Teacher satisfaction with the intervention and implementation(Up to two months.)
  • Caregiver satisfaction with the intervention and implementation(Up to two months.)
  • Family Navigator satisfaction with the intervention and implementation(Up to two months.)
  • Primary Care Provider satisfaction with the intervention and implementation(Up to two months.)
  • FN knowledge of child developmental disparities (health promotion).(Up to two months.)
  • Caregiver Knowledge of child developmental disparities (health promotion).(Up to two months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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