Recruiting

Observational Study

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT05900505

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Social Navigator

Study Details

Brief summary:

It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified.

Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support.

The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.

Conditions

Type 1 Diabetes

Study ID

NCT05900505

Start date

Jun 26, 2023

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

Phase 1

  • Parent or guardian of a child, aged between 0-17 years
  • Parent or guardian of a patient in the T1D or T2D clinics at CHEO

Phase 2

  • Parent or guardian of a child, aged between 0-17 years
  • Parent or guardian of a patient in the T1D or T2D clinics at CHEO
  • At least 1 positive response on the SDH Phase 1 Screening Tool
  • Optional: child consented to allow access to medical information via electronic medical chart

Exclusion Criteria:

  • Active social work client at the time of administration of the Phase 1 Screening Tool, defined as families who have had active follow up with a diabetes SW within the last 3 months, with plans for ongoing follow up.
  • Unable or unwilling to provide i) implied consent for the completion of the SDH Phase 1 Screening Tool and/or ii) written informed consent for participation in the Phase 2 randomized trial

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Participants in the intervention group will be referred to a social navigator to address their identified social needs.

no intervention: Control Group

Participants in the control group will be referred to a social worker, as per standard care.

Interventions

Social Navigator

The social navigator will assess patient/family needs and help them to access community resources (specific to their community) to address these, while promoting their engagement and self-efficacy.

Primary outcome measure

  • To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ). [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Elias Abou-Assaly, BA

613-737-7600eabouassaly@cheo.on.ca

Saunya Dover, MSc

613-737-7600sdover@cheo.on.ca

Locations

Children's Hospital of Eastern Ontario - Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Elias Abou-Assaly, BA

613-737-7600eabouassaly@cheo.on.ca

Saunya Dover, MSc

613-737-7600sdover@cheo.on.ca

Principal Investigator:

Caroline Zuijdwijk, MD

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Mar 25, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2024-03-25.