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临床试验/NCT03765281
NCT03765281已完成不适用

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

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2018年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
207
试验地点
2
主要终点
Youth Symptoms & Functioning Across Time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Youth Symptoms & Functioning Across Time

时间窗: Change in Youth Functioning from baseline to twelve months

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

时间窗: Change in Family Functioning from baseline to twelve months

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

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

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.

Caregiver Strain Across Time

时间窗: Change in Caregiver Strain from baseline to twelve months

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 Quality of Life Across Time

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anthony Levitt

Principal Investigator

Sunnybrook Health Sciences Centre

研究点 (2)

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