Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Change in Family Experiences Interview Schedule (FEIS) over 1 year
研究概览
简要总结
Roughly 40% of those with intellectual and developmental disabilities (IDD) have mental health needs, which is twice the national average. Nevertheless, there is dearth of evidenced-based mental health treatment for youth and young adults with IDD. The disparity in access to mental health care places those with IDD at greater risk of crisis service use. While telemental health studies demonstrate potential to enhance access to care, little of this research includes those with IDD, or crisis prevention and intervention. This project will refine and evaluate telemental health services for youth and young adults with IDD delivered within START (Systemic, Therapeutic, Assessment, Resources, and Treatment), a national, evidence-based model of crisis prevention and intervention for people with IDD. The study will begin with stakeholder feedback (service recipients, families, and providers) regarding telemental health services (Aim 1). Results will be used to refine the intervention. Our team will then compare telemental health versus in-person START services in a randomized control trial (Aim 2). To our knowledge, this will be the first trial of a telemental health crisis program for the IDD population. The final goal is to understand if outcomes vary across subpopulations (Aim 3) and to identify potential disparities. If found, the investigators will work with service users, families and providers to develop a strategy to address identified disparities in outcomes. The study will be executed by an interdisciplinary team of experts engaged with stakeholder partners. Understanding the benefits of specific telemental health methods has important implications to the design of interventions, within and outside of START. This telemental health study offers promise to address disparities in access to mental health care for people with IDD.
详细描述
Aim 1: Refine START (Systemic, Therapeutic, Assessment, Resources, and Treatment) telemental health practices to meet the needs of persons with IDD and mental health needs, their family caregivers, and providers.
The primary goal of Aim 1 is to identify strengths and weaknesses of telemental health START practices to inform the patient-centered intervention protocols used in Aim 2. The investigators hypothesize that our engagement approach and the qualitative methods used to design the telemental protocols will result in telemental health services that are accessible, acceptable, and inclusive in response to the diverse community of people with IDD-MH and their families.
The secondary goal of Aim 1 is to design the Person Experiences Interview Survey (PEIS), adapted from the gold-standard Family Experiences Interview Schedule (FEIS). The investigators hypothesize that our engagement approach and the qualitative methods used to design the Person Experiences Interview Survey (PEIS) will result in a self-report tool with content validity for youth and young adults with IDD and mental health service experiences as indicated by the relevance, comprehensiveness, and ease of understanding.
Aim 2: Compare the effectiveness of in-person START practices versus START telemental health using a randomized control design.
It is hypothesized that telemental health START will not be inferior to in-person START in the reduction of emergency psychiatric service use, time-to-discharge, and improvement in mental health stability and perceived quality of care. This finding will support the use of telemental health practices as a valuable alternative to in-person care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participant age 12-45 years
- •Lives in family setting
- •New START enrollee (within 90 days of enrollment)
- •Enrolled at an eligible START site
- •Able to obtain informed consent.
排除标准
- 未提供
研究组 & 干预措施
In-person START
In-person START will deliver all model components in-person. This is the established model.
干预措施: Intake and quarterly assessment: (Other)
In-person START
In-person START will deliver all model components in-person. This is the established model.
干预措施: Consultation & coping skills coaching: (Other)
In-person START
In-person START will deliver all model components in-person. This is the established model.
干预措施: 24-hour urgent crisis response and intervention: (Other)
In-person START
In-person START will deliver all model components in-person. This is the established model.
干预措施: Service linkages, referrals, outreach, & training: (Other)
Telemental health START
Telemental health START will deliver two components via telephonic or other communication technology (e.g., Zoom). This includes component #2 (consultation and coping skills coaching) and component #4 (service linkages, referrals, outreach, & training). START components #1 (intake and quarterly assessment) and #3 (24-hour urgent crisis response and intervention) will continue to be provided in-person.
干预措施: Intake and quarterly assessment: (Other)
Telemental health START
Telemental health START will deliver two components via telephonic or other communication technology (e.g., Zoom). This includes component #2 (consultation and coping skills coaching) and component #4 (service linkages, referrals, outreach, & training). START components #1 (intake and quarterly assessment) and #3 (24-hour urgent crisis response and intervention) will continue to be provided in-person.
干预措施: Consultation & coping skills coaching: (Other)
Telemental health START
Telemental health START will deliver two components via telephonic or other communication technology (e.g., Zoom). This includes component #2 (consultation and coping skills coaching) and component #4 (service linkages, referrals, outreach, & training). START components #1 (intake and quarterly assessment) and #3 (24-hour urgent crisis response and intervention) will continue to be provided in-person.
干预措施: 24-hour urgent crisis response and intervention: (Other)
Telemental health START
Telemental health START will deliver two components via telephonic or other communication technology (e.g., Zoom). This includes component #2 (consultation and coping skills coaching) and component #4 (service linkages, referrals, outreach, & training). START components #1 (intake and quarterly assessment) and #3 (24-hour urgent crisis response and intervention) will continue to be provided in-person.
干预措施: Service linkages, referrals, outreach, & training: (Other)
结局指标
主要结局
Change in Family Experiences Interview Schedule (FEIS) over 1 year
时间窗: Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]
A semi-structured interview of caregiver experiences with the mental health system
次要结局
- Change in Aberrant Behavior Checklist (ABC) at 1 year(Change in ABC scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)])
- Change in Crisis Service Use at 1 year(Change between enrollment to 1 year (or discharge))
- Time to discharge(continuous monitoring up to 1 year)
- Change in mental health stability as measured by START Plan scores at 1 year(Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge))