跳至主要内容
临床试验/NCT05091957
NCT05091957招募中不适用

CONNECTING FAMILIES: A Randomized Controlled Trial of Primary Care Poverty Screening and Financial Support Navigation for Families of Young Children

Queen's University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Parenting Stress Index- Short Form 4

研究概览

简要总结

Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.

详细描述

INTRODUCTION AND IMPORTANCE: Poverty and financial strain have profound and long-lasting negative impacts on both parent and child health, contributing to substantial health disparities. As the first contact with the health system for most families, primary care providers are uniquely positioned to address child poverty in clinical settings.

Many professional health organizations recommend that healthcare providers identify and address social determinants of health, but there is little evidence regarding the impact of effective interventions. Social systems are frequently complex and difficult to navigate; for example, low income Canadians are known to have lower tax filing rates than the general population. Therefore, many families may not be accessing all social benefits to which they are entitled. The investigators propose to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care using a randomized controlled trial to evaluate the impact on parent and child health outcomes. Results of our pilot study demonstrated feasibility and will inform our proposed full trial.

METHODS: Study Design: A multi-site, pragmatic, blinded, superiority, parallel-group randomized controlled trial will be conducted.

Participants: Families of children ages (from birth to 2 years), screening positive for the question "Do you ever have difficulty making ends meet at the end of the month?", identified as a good predictor of poverty.

Intervention and Active Comparator: Families will be randomly allocated to the intervention or active comparator group. Parents in the intervention group will have a review of their social needs and resources with a trained Community Service Worker (CSW) with a thorough understanding of potential income supports and community agencies and will assist the parent to access financially related social benefits for which they are eligible. All participants will receive a written summary of available resources.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of children (younger than 3 years) attending a regularly scheduled primary care visit.
  • Parents respond affirmatively to the question "Do you ever have difficulty making ends meet at the end of the month?"
  • Informed parental consent. Only one child will be enrolled per family. For families with more than one child, we will enroll the youngest eligible child, since literature suggests that impact of reducing family stress may be greater at younger ages; for multiple births, one child will be randomly selected for inclusion.

排除标准

  • Parents without legal status in Canada, as they are not eligible for many Canadian social programs.
  • Families who are receiving system navigation support, such as from a social worker or public health nurse, or who have received system navigation support within one year prior to enrolment.
  • Child with a previously diagnosed developmental disorder, genetic, chromosomal or syndromic condition.
  • Child born prematurely (gestational age less than 32 weeks).

研究组 & 干预措施

Community Support Worker

Experimental

structured review of participant income supports with a trained CSW, to identify financial needs and benefits for which the family is eligible, including assessment of income and food security, affordability of medications, housing and energy insecurity, and dental care. The visits will be conducted in person, by telephone or by videoconferencing, according to participant preference and to ensure adherence to COVID-19 pandemic-related criteria.

干预措施: Community Support Worker (Other)

Usual Care

Active Comparator

There is no clear standard of care and potential for practice variation in clinician responses to identified social need. Based on the ethical imperative to provide some support to families who identify unmet social needs, the comparator group will receive Usual Care, defined as: Participants in both groups will receive a written summary of available resources.

干预措施: Usual Care (Other)

结局指标

主要结局

Parenting Stress Index- Short Form 4

时间窗: 6 months

A 36-item parent-completed questionnaire assessing overall level of stress a person is feeling in their role as a parent. Scoring yields an overall stress score (range 36-180, with higher scores indicating greater stress) and sub-scores for Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child (each with range of 5-60) which are summed to generate the total score. .

次要结局

  • Household food security(6 months, 12 months)
  • Parent anxiety(6 months, 12 months)
  • Self Reported Household Income(6 months, 12 months)
  • Child general development(6 months, 12 months)
  • Participant use of community resources(6 months, 12 months)
  • Social Needs(6 months, 12 months)
  • Parent Depression(6 months, 12 months)
  • Child Social- Emotional Development(6 months,12 months)
  • Pediatric health system utilization(6 months, 12 months)
  • Parent health system utilization(6 months, 12 months)

研究者

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

Imaan Bayoumi

Associate Professor

Queen's University

研究点 (2)

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