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

NCT03765281 | Completed DMC

• 1 other identifier: 040-2018
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder; Addiction

Outcome Measures

Primary Outcomes (5)

• 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.

  Change in Caregiver Strain from baseline to twelve months

• 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.

  Change in Youth Functioning from baseline to twelve months

• 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.

  Change in Family Functioning from baseline to twelve months

• 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.

  Change in Caregiver Quality of Life from baseline to twelve months

• 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.

  Change in Youth Quality of Life from baseline to twelve months

Other Outcomes (2)

• Health Services Utilization Questionnaire over time

  Change in Health Services Utilization from baseline to twelve months

• Health Services Satisfaction Questionnaire

  Change in Health Services Satisfaction from baseline to twelve months

Study Arms (2)

Navigation

EXPERIMENTAL

Navigation intervention plus Resource List

Other: Navigation; Other: Resource List

Self-Navigation

ACTIVE COMPARATOR

Resource List intervention

Other: Resource List

Interventions

Navigation OTHER

Service delivered by clinical Navigator who learns about youth and family's needs and matches to appropriate services.

Navigation

Resource List OTHER

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.

Navigation; Self-Navigation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Mental Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Anthony Levitt, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: December 5, 2018
• Study Start: July 2, 2018
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)