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Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families

Primary Purpose

Mental Health Disorder, Addiction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Navigation
Resource List
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • family member of youth age 13 to 26 who is experiencing a mental health concern and/or substance use issue
  • residing in the Greater Toronto Area
  • seeking mental health and/or addictions services or supports

Exclusion Criteria:

  • currently in crisis
  • previously received navigation support at Sunnybrook Health Sciences Centre.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Navigation

Self-Navigation

Arm Description

Navigation intervention plus Resource List

Resource List intervention

Outcomes

Primary Outcome Measures

Caregiver Strain Across Time
Caregiver Strain Questionnaire as measure of functional and health outcomes for the youth and family (CSQ; Bickman et al., 2012); Clinical Outcome #1. Total Scale Range= Min: 7, Max: 35. Higher scores: worst outcome.
Youth Symptoms & Functioning Across Time
Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012); Clinical Outcome #2. Total Scale Range= Min: 26, Max: 130. Higher scores = worst outcome.
Family Functioning Across Time
Olson Family Satisfaction Scale (FSS, Olson, 2010); Clinical Outcome #3. Total scale range = Min: 10, Max: 50. Higher scores = better outcome.
Caregiver Quality of Life Across Time
World Health Organization Quality of Life Instruments (WHOQOL-BREF Field Trial Version, WHOQOL Group, 1991); Clinical Outcome #4. Total Scale Range = Min: 4, Max: 20. High scores = better outcome.
Youth Quality of Life Across Time
Kid - & Kiddo-KINDL Parent's Questionnaire KINDL Quality of Life Questionnaire for Children (Kid- & Kiddo-KINDL, Ravens-Sieberer & Bullinger, 2000); Clinical Outcome #5. Total Scale Range = Min: 24, Max: 120. High scores = better outcome.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2018
Last Updated
May 3, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03765281
Brief Title
Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families
Official Title
Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial (Phase II) will assess the different methods of supporting families in finding mental health and/or addictions (MHA) services for youth. Youth with MHA issues and their families are particularly vulnerable in the MHA system, due to a lack of specialized support and complicated transitions between services. This study will assess the potential impact of Navigation on youth MHA symptom reduction or functional improvement, family functioning, satisfaction with MHA services, as well as the cost-benefit of Navigation. This project will seek to determine whether there is a difference for those youth with MHA issues and their families who receive Navigation over those who find and access MHA care on their own.
Detailed Description
This pilot feasibility trial (Phase I) assessed the feasibility to conduct a randomized controlled trial examining whether families of youth ages 13 to 26 with mental illness and/or addiction concerns who receive Navigation services experience improved clinical outcomes compared to families who interact with the MHA care system on their own (usual care). This pilot feasibility trial (Phase I) assessed the different methods of supporting families in finding mental health and/or addictions (MHA) services for youth. Youth with MHA issues and their families are particularly vulnerable in the MHA system, due to a lack of specialized support and complicated transitions between services. This study assessed the potential impact of Navigation on youth MHA symptom reduction or functional improvement, family functioning, satisfaction with MHA services, as well as the cost-benefit of Navigation and sought to determine whether there is a difference for those youth with MHA issues and their families who receive Navigation over those who find and access MHA care on their own. The primary outcomes for Phase I of this trial were: Recruitment rate as a measure of recruitment feasibility (baseline): tracking of recruitment rate to determine whether it is high enough for a full-scale trial to be feasible. Change in acceptability of study methods across time (two months and four months): Acceptability of Procedures and assessments by participants as measure of protocol feasibility (Questionnaire developed based on the Theoretical Framework of Acceptability, Sekhon et al., 2017). Study Completion Rate (four months): tracking of study completion rate to determine whether it is high enough for a full-scale trial to be feasible. The secondary outcomes for Phase I of this trial were: Caregiver Strain Across Time (baseline, two months, four months): Caregiver Strain Questionnaire as measure of functional and health outcomes for the youth and family (CSQ; Bickman et al., 2012). Clinical Outcome #1. Youth Symptoms & Functioning Across Time (baseline, two months and four months): Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012).Clinical Outcome #2.Total Scale Range= Min: 26, Max: 130. Higher values = worst outcome. Family Functioning Across Time (baseline, two months and four months) (baseline, two months and four months): Olson Family Satisfaction Scale (FSS, Olson, 2010). Clinical Outcome #3. Total Scale range = Min: 10, Max: 50. High values = better outcome. Youth Emotion & Behaviour Symptoms Across Time (baseline and four months): Child and Adolescent Symptom Inventory (CASI, Sprafkin et al., 2010). Clinical Outcome #4. Total Scale Range = Min 29, Max: 87. Higher values = worst outcome. Caregiver Quality of Life Across Time (baseline and four months): Medical Outcomes Survey Short-Form (SF-36, RAND Health, 2018). Clinical Outcome #5. Total Scale Range = Min: 36, Max: 180. Higher values = worst outcome. Youth Quality of Life Across Time (baseline and four months): Medical Outcomes Survey Short-Form (SF-36; RAND Health, 2018). Clinical Outcome #6. Total Scale Range = Min: 36, Max: 180. Higher values = worst outcome. Other outcome measures: Health Services Utilization over time (baseline and four months): Health Services Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services for purposes of cost change estimates. Health Services Utilization over time (baseline and four months): Child and Adolescent Services Assessment (CASA; Ascher et al., 1996); Reporting of access of health services for services usage estimates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Addiction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Navigation
Arm Type
Experimental
Arm Description
Navigation intervention plus Resource List
Arm Title
Self-Navigation
Arm Type
Active Comparator
Arm Description
Resource List intervention
Intervention Type
Other
Intervention Name(s)
Navigation
Intervention Description
Service delivered by clinical Navigator who learns about youth and family's needs and matches to appropriate services.
Intervention Type
Other
Intervention Name(s)
Resource List
Intervention Description
Extensive list of mental health and addictions resources, information, and services. Contact information and web links provided for individuals to explore and contact resources of interest.
Primary Outcome Measure Information:
Title
Caregiver Strain Across Time
Description
Caregiver Strain Questionnaire as measure of functional and health outcomes for the youth and family (CSQ; Bickman et al., 2012); Clinical Outcome #1. Total Scale Range= Min: 7, Max: 35. Higher scores: worst outcome.
Time Frame
Change in Caregiver Strain from baseline to twelve months
Title
Youth Symptoms & Functioning Across Time
Description
Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012); Clinical Outcome #2. Total Scale Range= Min: 26, Max: 130. Higher scores = worst outcome.
Time Frame
Change in Youth Functioning from baseline to twelve months
Title
Family Functioning Across Time
Description
Olson Family Satisfaction Scale (FSS, Olson, 2010); Clinical Outcome #3. Total scale range = Min: 10, Max: 50. Higher scores = better outcome.
Time Frame
Change in Family Functioning from baseline to twelve months
Title
Caregiver Quality of Life Across Time
Description
World Health Organization Quality of Life Instruments (WHOQOL-BREF Field Trial Version, WHOQOL Group, 1991); Clinical Outcome #4. Total Scale Range = Min: 4, Max: 20. High scores = better outcome.
Time Frame
Change in Caregiver Quality of Life from baseline to twelve months
Title
Youth Quality of Life Across Time
Description
Kid - & Kiddo-KINDL Parent's Questionnaire KINDL Quality of Life Questionnaire for Children (Kid- & Kiddo-KINDL, Ravens-Sieberer & Bullinger, 2000); Clinical Outcome #5. Total Scale Range = Min: 24, Max: 120. High scores = better outcome.
Time Frame
Change in Youth Quality of Life from baseline to twelve months
Other Pre-specified Outcome Measures:
Title
Health Services Utilization Questionnaire over time
Description
Health Services Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services for purposes of cost change estimates.
Time Frame
Change in Health Services Utilization from baseline to twelve months
Title
Health Services Satisfaction Questionnaire
Description
Reporting of satisfaction with health services accessed.
Time Frame
Change in Health Services Satisfaction from baseline to twelve months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: family member of youth age 13 to 26 who is experiencing a mental health concern and/or substance use issue residing in the Greater Toronto Area seeking mental health and/or addictions services or supports Exclusion Criteria: currently in crisis previously received navigation support at Sunnybrook Health Sciences Centre.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Levitt, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families

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