Connecting Families

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091957
• Other study ID #: FMED-6797-21
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: Imaan Bayoumi
• Phone: 613-331-2371
• Email: bayoumi[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Outcomes: The primary outcome, measured 6 months after enrollment, is parenting stress, as measured by the Parenting Stress Index-Short Form. Secondary outcomes are change in: a) self-reported after-tax household income; b) household food security; c) parent depression; d) child development; e) child social, emotional and behavioural health; f) Community Service Worker workload; g) health care utilization. TEAM EXPERTISE: The study is a collaboration between TARGet Kids!, (a well-established child-focused primary care practice-based research network) and integrated Knowledge Users (parents, administrators and policy makers). The research team has expertise in child health, pragmatic trials and social determinants of health. EXPECTED OUTCOME: Results from this research will address a critical evidence gap regarding a feasible and scalable intervention to address child poverty in the primary care practice setting. Leveraging primary preventive care in early childhood, which is accessed by almost all families, will provide powerful opportunities for implementation. Effective interventions to address child poverty and financial strain in clinical practice have the potential to influence child health trajectories over their life course.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 3 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Parents without legal status in Canada, as they are not eligible for many Canadian social programs.

2. 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.

3. Child with a previously diagnosed developmental disorder, genetic, chromosomal or syndromic condition.

4. Child born prematurely (gestational age less than 32 weeks).

Related Conditions & MeSH terms

• Intervention
• Poverty
• Primary Care

Intervention

Other:
• Community Support Worker
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.
• Usual Care
Participants in both groups will receive a written summary of available resources

Locations

Country	Name	City	State
Canada	Queen's Family Health Team	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting Stress Index- Short Form 4	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. .	6 months
Secondary	Self Reported Household Income	Self Reported Household Income from all sources	6 months, 12 months
Secondary	Participant use of community resources	This is a study specific instrument which assesses participants' receipt of a comprehensive suite of financial benefits (including specific income tax benefits, benefits through social assistance programs) and receipt of emergency food services, childcare subsidy, energy assistance, support for medication and dental costs and housing needs.	6 months, 12 months
Secondary	Household food security	18-item Household Food Security Survey Module, asks about the household's experiences of food insecurity during the previous year. Higher scores indicate increased food insecurity and households are classified as food secure, marginally food insecure, moderately food insecure or severely food insecure.	6 months, 12 months
Secondary	Social Needs	WE Care Survey, s a 10-item questionnaire assessing needs in 4 domains (economic stability, education, neighborhood & physical environment, and food) and whether participants want help with identified needs..	6 months, 12 months
Secondary	Parent Depression	Patient Health Questionnaire - 9, a 9 item self completed instrument measuring symptoms of depression (range 0-27 with higher scores indicating worse outcome).	6 months, 12 months
Secondary	Parent anxiety	Generalized Anxiety Disorders-7, a 7 item self completed instrument measuring symptoms of anxiety (range 0-21, with higher scores indicating worse outcome).	6 months, 12 months
Secondary	Child Social- Emotional Development	Ages and Stages: Social Emotional, age specific parent completed questionnaires assessing the child's social and emotional development, in which higher scores indicate better outcomes.	6 months,12 months
Secondary	Child general development	Ages and Stages-3: age specific parent completed questionnaires assessing the child's s development in 5 developmental areas (Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social), in which higher scores indicate better outcomes.	6 months, 12 months
Secondary	Pediatric health system utilization	Through linkage with health administrative databases, the investigators will assess differences in health services utilization. The following administrative databases will be used: Ontario Health Insurance Plan (OHIP) which includes physician billings (fee for service and shadow billing) for physician visits, the National Ambulatory Care Reporting System (NACRS) which includes data on emergency department visits, and the Discharge Abstracts Database (DAD) which includes data on inpatient hospitalizations. We will assess between-group differences in primary care visits, low acuity emergency department visits (CTAS 3-5), number of hospitalizations and length of stay.For children, primary care visits will be categorized as well-child visits (which may appropriately increase) and other visits (which may be reduced).	6 months, 12 months
Secondary	Parent health system utilization	Through linkage with health administrative databases, the investigators will assess differences in health services utilization. The following administrative databases will be used: Ontario Health Insurance Plan (OHIP) which includes physician billings (fee for service and shadow billing) for physician visits, the National Ambulatory Care Reporting System (NACRS) which includes data on emergency department visits, and the Discharge Abstracts Database (DAD) which includes data on inpatient hospitalizations.We will assess between-group differences in primary care visits, low acuity emergency department visits (CTAS 3-5), number of hospitalizations and length of stay.	6 months, 12 months