Connecting Families

NCT ID: NCT05091957

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2026-04-30

Brief 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.

Detailed 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.

Conditions

Poverty; Primary Care; Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Community Support Worker

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Participants in both groups will receive a written summary of available resources

Interventions

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.

Intervention Type: OTHER

Usual Care

Participants in both groups will receive a written summary of available resources

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Imaan Bayoumi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen's Family Health Team

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Imaan Bayoumi

Role: CONTACT

bayoumi@queensu.ca

613-331-2371

Cornelia Borkhoff

Role: CONTACT

cory.borkhoff@sickkids.ca

647-883-9270

Facility Contacts

Dane Mauer-Vakil

Role: primary

vdm@queensu.ca

613-533-9303

Other Identifiers

FMED-6797-21

Identifier Type: -

Identifier Source: org_study_id