Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03765281 |
| Other study ID # |
040-2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2, 2018 |
| Est. completion date |
March 4, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
