Targeting Child Mental Health and Household Poverty

NCT05667675 | Completed

• 1 other identifier: SEAMO IF Bayoumi
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Living in poverty has long-lasting negative effects on children's mental health and on their mental health in adulthood. Child poverty is very common, affecting 17% of Canadian children. Many low income families may not be getting all the social benefits they are entitled to receive. Increasingly, there are calls for primary care providers to ask all patients about poverty and to intervene if poverty is identified. However, it is not known if an intervention can improve children's health. This study will test the effect of having a Community Support Worker work with families of children age 2-5 years during a primary care visit to identify unmet financially related social needs (like food, housing or energy insecurity) and help families navigate the social service system. The Community Support Worker will help families complete income tax, apply for benefits and community supports to which they are entitled. The investigators will study the effect on child emotional and behavioural health, parent stress and depression and family income. Results from this study will help health care providers and policy makers understand whether this is an effective way to integrate the health and social service systems to improve child and parent health.

Conditions

Poverty; Child Health; Behavior Problem

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire, Total Difficulties Score

  A validated 25 item mental health questionnaire for children 2-17 years old on 5 domains (emotional problems, conduct problems, hyperactivity/inattention, peer problems and a prosocial scale). The first 4 scales are combined to give a Total Difficulties Score. Items in the first four scales are assigned a score of 0-2 (0 indicates 'Not True', 1 indicates 'Somewhat True' and 2 indicates 'Certainly True'). Reverse scoring is used for the Prosocial scale. Subscale totals range from 0-10 and the Total Difficulties Score can range from 0-40. Higher scores reflect greater difficulties for the Difficulties scores, and greater prosocial behaviour for the Prosocial score.

  6 months after enrollment.

Secondary Outcomes (1)

• Strengths and Difficulties Questionnaire, Total Difficulties Score

  12 months after enrollment

Other Outcomes (2)

• Parenting Stress Index SF IV

  6 and 12 months after enrollment

• Recruitment and Retention Rate

  12 months after enrollment

Study Arms (2)

Community Support Worker

EXPERIMENTAL

Participants in the intervention group will have a structured review of their financially related needs and resources with a trained CSW, who will have a thorough understanding of potential income supports and community support agencies. The CSW will use a structured approach to identify financial needs and benefits for which the family is eligible The CSW will work intensively with families in the intervention arm to identify and meet their goals. They will conduct weekly meetings to complete forms, and provide advocacy (in person and by telephone) as needed up to six meetings as needed for system navigation.

Behavioral: Community Support Worker

Control

ACTIVE COMPARATOR

There is no clear standard of care and potential for practice variation in clinician responses to identified social need. For this proposal, participants in the comparator group will receive Usual care, defined as: Participants in both groups will receive a written summary of available resources.

Behavioral: Control

Interventions

Community Support Worker BEHAVIORAL

Participants in the intervention group will have a structured review of their financially related needs and resources with a trained CSW, who will have a thorough understanding of potential income supports and community support agencies. The CSW will use a structured approach to identify financial needs and benefits for which the family is eligible The CSW will work intensively with families in the intervention arm to identify and meet their goals. They will conduct weekly meetings to complete forms, and provide advocacy (in person and by telephone) as needed up to six meetings as needed for system navigation.

Community Support Worker

Control BEHAVIORAL

There is no clear standard of care and potential for practice variation in clinician responses to identified social need. For this proposal, participants in the comparator group will receive Usual care, defined as: Participants in both groups will receive a written summary of available resources.

Control

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children age 2-5y attending a routinely scheduled visit with their primary care provider. - - 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.

You may not qualify if:

• Child born prematurely (gestational age less than 32 weeks)
• birthweight less than 2500g
• Parent unable to communicate in English.
• Parents without legal status in Canada.
• Families already receiving support with system navigation, such as from a social worker or public health nurse.

Sponsors & Collaborators

• Imaan Bayoumi: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

Location

Related Publications (1)

• Bayoumi I, Parkin PC, Martin M, Keown-Stoneman CDG, Birken CS, Maguire JL, Borkhoff CM. Connecting Families: Poverty Screening and Financial Support Navigation for Families of Young Children in Primary Care: A Pilot Randomized Controlled Trial. Acad Pediatr. 2025 Jul;25(5):102820. doi: 10.1016/j.acap.2025.102820. Epub 2025 Mar 24.

  PMID: 40139488 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Imaan Bayoumi, MD, MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It will not be possible to blind participants to their group allocation. However, study information materials and the consent form will indicate that after consenting they will be randomly allocated to one of two approaches to providing support, without a detailed description of the interventions. This approach will provide some degree of blinding of participants. Additionally, RAs conducting outcomes assessment visits, the biostatistician and investigators will remain blind to each child's group allocation. Blinding will be achieved by having the group allocation coded as A and B in the database; group allocation will be concealed until the final data analysis is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A pragmatic, 1:1 allocation, parallel-group superiority pilot randomized controlled trial will be conducted.

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 28, 2022
• Study Start: April 18, 2019
• Primary Completion: March 30, 2022
• Study Completion: July 31, 2024
• Last Updated: October 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication of study results.
• Access Criteria: Data will be made available to researchers whose proposed use of the data has been approved.

Locations

CA (1)