Clinical trial NCT05091957: Connecting Families
Official title: CONNECTING FAMILIES: A Randomized Controlled Trial of Primary Care Poverty Screening and Financial Support Navigation for Families of Young Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Poverty
Primary Care
Intervention
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-centred, pragmatic, 1:1 allocation, parallel-group superiority randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Parenting Stress Index- Short Form 4
timeFrame: 6 months
Secondary outcomes:
measure: Self Reported Household Income
timeFrame: 6 months, 12 months
measure: Participant use of community resources
timeFrame: 6 months, 12 months
measure: Household food security
timeFrame: 6 months, 12 months
measure: Social Needs
timeFrame: 6 months, 12 months
measure: Parent Depression
timeFrame: 6 months, 12 months
measure: Parent anxiety
timeFrame: 6 months, 12 months
measure: Child Social- Emotional Development
timeFrame: 6 months,12 months
measure: Child general development
timeFrame: 6 months, 12 months
measure: Pediatric health system utilization
timeFrame: 6 months, 12 months
measure: Parent health system utilization
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
Study officials:
References: