- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05667675
Targeting Child Mental Health and Household Poverty
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Randomization rate: there is a reasonably high probability that at least 50% of approached parents will agree to randomization.
- Retention and completion rate: there is a reasonably high probability that at least 80% of participants will complete the trial.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5E9
- Queen's Family Health Team
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community Support Worker
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.
|
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.
|
|
Active Comparator: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire, Total Difficulties Score
Time Frame: 6 months after enrollment.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire, Total Difficulties Score
Time Frame: 12 months after enrollment
|
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.
|
12 months after enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Stress Index SF IV
Time Frame: 6 and 12 months after enrollment
|
A validated 36 item questionnaire in parents of children older than 1 month assessing child anxiety/mood (Internalizing Symptoms), relationships and attachment and parent, caregiver and family mental health and functioning.
Scoring yields an overall stress score and sub-scores for Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child
|
6 and 12 months after enrollment
|
|
Recruitment and Retention Rate
Time Frame: 12 months after enrollment
|
Proportion of potential participants who are eligible and enrolled will be tracked.
Proportion of individuals with complete data collection at 6 and 12 months will be determined to calculate retention rate.
|
12 months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Imaan Bayoumi, MD, MSc, Queen's University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEAMO IF Bayoumi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Child Health
-
University of South CarolinaCompletedParents | Child Behavior | Child Health | Child, PreschoolUnited States
-
Chinese University of Hong KongCompletedChild HealthHong Kong
-
University of CalgaryAlberta Children's Hospital; Provincial Health Services Authority; Brain Canada; MindSea Development and other collaboratorsRecruitingParenting | Child Development | Child Mental Health | Parent Mental HealthCanada
-
Children's Hospital of Fudan UniversityFirst Affiliated Hospital Xi'an Jiaotong University; Jiangxi Province Children...Active, not recruiting
-
Linkoeping UniversityUppsala University; Örebro University, Sweden; Stockholm UniversityRecruiting
-
Center for Primary Care and Public Health (Unisante)...Swiss Tropical & Public Health Institute; Ecole Polytechnique Fédérale de Lausanne and other collaboratorsCompleted
-
Center for Primary Care and Public Health (Unisante)...Swiss Tropical & Public Health Institute; Ifakara Health Institute; University... and other collaboratorsCompleted
-
University of UtahRobert Wood Johnson FoundationCompletedChild Abuse | Primary Health Care | Child WelfareUnited States
-
Mbarara University of Science and TechnologyMassachusetts General Hospital; University of Alabama at BirminghamCompletedMaternal Child HealthUganda
-
Liverpool John Moores UniversityUniversity of Otago; Newcastle University; University of Strathclyde; University... and other collaboratorsCompletedPhysical Activity | Child | Child Development | Health BehaviorUnited Kingdom
Clinical Trials on Community Support Worker
-
University of MinnesotaCompleted
-
Medstar Health Research InstituteGeorgetown University; George Washington University; Howard UniversityActive, not recruitingBreast Cancer | Prostate Cancer | Social Determinants of Health | Disparities | Health EquityUnited States
-
Stanford UniversityCalifornia Initiative to Advance Precision Medicine; Pacific Cancer Care; The... and other collaboratorsCompleted
-
VA Office of Research and DevelopmentDurham VA Medical CenterNot yet recruitingUsing Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans (PATH)Cancer | Dementia | Renal Disease | Obstructive Pulmonary DiseaseUnited States
-
University of PennsylvaniaWestat; City of Phladelphia - Office of Community Empowerment and OpportunityRecruitingCardiovascular Diseases | Disparities | Community Health Workers | Social Determinants of Health (SDOH)United States
-
University of Texas at AustinCompleted
-
Public Health - Seattle and King CountyNational Institute of Environmental Health Sciences (NIEHS)Completed
-
University GhentCompletedCovid 19 | Mental Health Impairment | Social IsolationBelgium
-
Jury CandelarioMerck Sharp & Dohme LLCUnknown