Clinical trial NCT05667675: Targeting Child Mental Health and Household Poverty
Official title: Targeting Child Mental Health and Household Poverty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poverty
Child Health
Behavior Problem
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2022-12-28
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, 1:1 allocation, parallel-group superiority pilot randomized controlled trial will be conducted.
Primary purpose: TREATMENT

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.

Detailed description: Background: Child poverty remains a prevalent problem in Canada, affecting 17% of Canadian children. There are profound negative impacts on child health related to poverty, particularly when the exposure is prolonged or occurs in early childhood, affecting mental health (higher prevalence of depression, conduct disorders and ADHD) and school readiness. Socio-economic health disparities are estimated to cost the health care system $6.2 billion annually. Moreover, investments in early childhood have an estimated annual return of investment of 7-10%.

Emotional and behavioural problems, including depression, anxiety, conduct and hyperactivity problems) serious enough to impair daily function occur in 14-26% of preschool children, with increased risk in low income families and those with lower parental education. Furthermore, vulnerability in emotional and behavioural domains in Kindergarten is associated with poor future academic performance and is more prevalent in low income families. Poor mental health trajectories in preschool age children are associated with high family stress and maternal depression. In turn, reduced family stress is associated with fewer child behaviour problems. Additionally, chronic exposure to poverty has been associated with poor mental health along a gradient, in which those most affected were always poor, followed by those experiencing intermittent poverty and finally, those least affected were never poor.

An estimated 40-60% of preschool children with significant emotional and behavioural symptoms will continue to experience problems 10 years later and are at increased risk for mental health problems in adulthood. A growing body of scientific evidence demonstrates the mechanisms by which social and environmental early life exposure directly influences the architecture of the young developing brain. Both the Canadian Paediatric Society and the American Academy of Pediatrics take the position that "adult diseases should be viewed as developmental disorders beginning early in life and that persistent health disparities associated with poverty, discrimination and maltreatment can be reduced by the alleviation of toxic stress in childhood". Poverty has been associated with demonstrated changes in brain architecture, affecting the temporal lobe, amygdala, hippocampus and prefrontal cortex, areas of the brain critical to decision making, emotional regulation, mood and impulse control, language development and memory. Such permanent early changes in brain development establish a poor foundation for future mental health and learning and help to explain persistent health, educational and social disparities. Given the long-term impact of childhood poverty on overall health, effective interventions have the potential to translate into improved health outcomes and significant healthcare savings.

Community Support Workers: Community Support Workers (CSW) provide health education, anticipatory guidance, supported attendance at medical appointments and adherence to medically recommended care to families. These visits have been shown to improve immunization rates, and access to dental care. However, their role in addressing poverty and other unmet social needs and child behavioural health has not been studied. The CSW role has been implemented in the SELHIN in several primary care settings with the goal of addressing unmet social needs for high need patients. CSWs have a thorough understanding of available income supports and community support agencies and review social needs, such as food, housing and energy insecurity. They help patients access social benefits for which they are eligible, including ensuring up-to-date completion of income tax returns, application for disability benefits, benefits such as the Special Diet allowance, and other programs. The tax system is the principal policy mechanism to provide critically needed social benefits to Canadians, however many eligible Canadians lack the awareness, knowledge and confidence to access all benefits they are entitled to receive. Many low income Canadians, particularly those facing additional barriers such as women living with their children in shelters, Indigenous people and young parents, have disproportionately lower tax filing rates and are therefore not benefiting from many government social supports. The impact of the Canada Child Benefit, established in 2016 is still not known; however,it is likely that many eligible families have not applied. The impact of this integrated income support role in primary care on child and parent health is not known. Addressing this knowledge gap will inform policy changes, potentially encouraging scaling up the CSW role to additional primary care models, including team-based, sole proprietor family medicine, pediatrics and nurse practitioner led clinics.

This project builds on a previously funded SEAMO IF project, 'Implementation of a clinical poverty intervention tool --Phase 1: Process evaluation', which determined that poverty screening by physicians was seen as important by clinicians and highly acceptable to patients. Clinicians found universal screening to be difficult, in part because they were not confident in their ability to address identified needs. This project builds on these findings by embedding and evaluating an intervention, which will establish the health outcomes associated with a structured poverty intervention.

Significance and innovation: A recent systematic review summarized the literature on health care interventions to address unmet social needs in the U.S. A single study examining child health outcomes associated with an intervention targeting income security, found fewer social needs and improved caregiver reported overallchild health.26 To date, the health outcomes for children or parents associated with poverty screening in Canadian health care settings, in the context of universally available healthcare have not been evaluated. There is consensus on the need to address social determinants to improve health and reduce health system costs, but little is known about effective interventions. Specifically, it is unclear whether structured review of financially-related social needs and social system navigation for low income families can improve child emotional and behavioural health and parent mental health outcomes.

Objective: To execute an internal pilot study, in preparation for a multi-site full trial to determine if structured review of financially-related social needs and social system navigation for low income families can improve child emotional and behavioural health and reduce parent stress and depression.

Rationale: Health care providers increasingly endorse the importance of social needs and good health but report low confidence in their ability to meet their patients' unmet social needs. The College of Family Physicians of Canada (CFPC) recommends screening patients using the single question "Do you ever have difficulty making ends meet at the end of the month?" However, neither screening nor intervention tools are routinely used in primary practice and to date, the impact of poverty screening on health outcomes has not been evaluated in Canada.

Specific Hypotheses of the Internal Pilot:

1. Randomization rate: there is a reasonably high probability that at least 50% of approached parents will agree to randomization.
2. Retention and completion rate: there is a reasonably high probability that at least 80% of participants will complete the trial.
3. Feasibility of primary and secondary outcomes: there is a reasonably high probability that at least 80% of participants will complete the primary and secondary outcomes.
4. Sample size estimates: The standard deviation for the primary outcome used to determine the sample size for the full trial is no less than 10% lower than the one observed in the pilot.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire, Total Difficulties Score
timeFrame: 6 months after enrollment.
Secondary outcomes:
measure: Strengths and Difficulties Questionnaire, Total Difficulties Score
timeFrame: 12 months after enrollment
Other outcomes:
measure: Parenting Stress Index SF IV
timeFrame: 6 and 12 months after enrollment
measure: Recruitment and Retention Rate
timeFrame: 12 months after enrollment
Locations:
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
Study officials:
affiliation: Queen's University
name: Imaan Bayoumi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: