Connecting Families

NCT05091957 | Recruiting DMC

• 1 other identifier: FMED-6797-21
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Care; Intervention; Poverty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Self Reported Household Income

  6 months, 12 months

• Participant use of community resources

  6 months, 12 months

• Household food security

  6 months, 12 months

• Social Needs

  6 months, 12 months

• Parent Depression

  6 months, 12 months

Study Arms (2)

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.

Other: Community Support Worker

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.

Other: Usual Care

Interventions

Community Support Worker 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.

Community Support Worker

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 1 Day - 3 Years
• Gender Eligibility Details: Self reported
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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?"

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

RECRUITING

Related Publications (1)

• Bayoumi I, Parkin PC, Tabassum F, Johnson C, Sherwood M, Mitchell M, Birken CS, Bloch G, Carsley S, Cole M, Green M, Keown-Stoneman CDG, Maguire JL, Purkey E, van den Heuvel M, Weir S, Wong P, Borkhoff CM. Connecting families-randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol. BMJ Open. 2026 Feb 6;16(2):e111158. doi: 10.1136/bmjopen-2025-111158.

  PMID: 41651520 DERIVED

Central Study Contacts

Imaan Bayoumi

CONTACT

613-331-2371; bayoumi@queensu.ca

Cornelia Borkhoff

CONTACT

647-883-9270; cory.borkhoff@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A multi-centred, pragmatic, 1:1 allocation, parallel-group superiority randomized controlled trial

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 25, 2021
• Study Start: May 17, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning with publication of main study results to 5 years later.
• Access Criteria: Upon reasonable request directed to the principal investigators via email.

Locations

CA (1)