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Mental Health DisorderNCT03765281

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

A study testing Navigation and Resource List in people with Mental Health Disorder and Addiction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Mental Health Disorder, Addiction
What is being tested?
Navigation and Resource List
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
1 siteCanada
Study dates
2 Jul 2018to 4 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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.

Read the 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:

  1. 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.
  2. 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).
  3. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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:

  1. 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.
  2. 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.
Being tested
Navigation, Resource List
Medical subject headings
Mental Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavigationOther

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

  • Resource ListOther

    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.

Study groups in NCT03765281
Study groupRoleWhat they receive
NavigationExperimentalNavigation intervention plus Resource List
Receives: Other: Navigation; Other: Resource List
Self-NavigationActive comparatorResource List intervention
Receives: Other: Resource List

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change in Caregiver Strain from baseline to twelve months

  2. 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.

    Measured: Change in Youth Functioning from baseline to twelve months

  3. 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.

    Measured: Change in Family Functioning from baseline to twelve months

  4. 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.

    Measured: Change in Caregiver Quality of Life from baseline to twelve months

  5. 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.

    Measured: Change in Youth Quality of Life from baseline to twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start2 Jul 2018
  3. Primary completion4 Mar 2022
  4. Study completion4 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03765281
Sponsor's protocol ID
040-2018
Status last verified
May 2022
First submitted
28 Jun 2018
Last updated
4 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Navigation and Resource List in people with Mental Health Disorder and Addiction, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Strain Across Time (time frame: Change in Caregiver Strain from baseline to twelve months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.

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