Altitudes: A Blended Digital Health Intervention to Support Caregivers and Other Supporters of Young People With Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score
研究概览
简要总结
The purpose of the present study is to investigate the feasibility, accessibility, and potential clinical benefits of implementing a moderated online social media platform with therapeutic content, Altitudes, to parents, caregivers, and supporters of young people with psychosis across the state of North Carolina, including in Coordinated Specialty Care (CSC) programs, Specialized Treatment Early in Psychosis (STEP) programs, and other community services where caregivers or supporters of young persons experiencing psychosis receive care. The investigators will evaluate acceptability and feasibility with up to 50 caregivers and supporters over the course of 6 months. Acceptability and usability will be assessed with various acceptability measures with the Altitudes caregivers and supporters, and caregivers and supporters' engagement with the digital platform. The investigators will additionally evaluate the impact of the platform on caregiver and supporter's psychological status, well-being, and social support, as measured via self-report questionnaires.
详细描述
Purpose: The purpose of the present study is to investigate the feasibility, accessibility, and potential clinical benefits of implementing a moderated online social media platform with therapeutic content, Altitudes, to parents, caregivers, and supporters of young people with psychosis across the state of North Carolina, including in CSC programs, STEP programs, and other community services where caregivers or supporters of young persons experiencing psychosis receive care.
Participants: Fifty parent or supporter participants from CSC clinics (OASIS, SHORE, Eagle, Encompass, AEGIS, and WeCare2), STEP programs, or community services will be recruited for Altitudes.
Procedures (methods): All participants will be recruited over a 20-week to 28-week period at from the North Carolina's community services. Participants will engaged with the digital platform, known as Altitudes, for approximately 6 months. Site usage information as well as feedback about their experience will be collected from these participants through the Altitudes platform. Site usage information (e.g., number of posts/comments made on the site, the number and types of 'Journeys' or 'Tracks' [psychoeducation and therapeutic content] completed by participants, etc.) will be collected automatically through the Altitudes platform. Before being given access to Altitudes, a research coordinator, family peer support specialist, or moderator will provide instructions and guidance for using the site (i.e., Altitudes onboarding). Experiences, wellbeing, and support measures will be collected at baseline, mid-treatment (~3 months) and post-treatment (~6 months) for the Altitudes participants. As Altitudes involves psychoeducational and therapeutic content, this platform is considered an adjunct to care parents and supporters may be receiving. As such, Altitudes participants will not be compensated for their involvement in the platform. Site usage information will be collected automatically through the Altitudes site. However, Altitudes participants will be compensated for providing feedback about their experience with Altitudes as well as for completing other assessments. Finally, Altitudes will be monitored at least once daily by trained family peer support specialists, master's or Ph.D. level clinicians, and/or graduate students with relevant clinical/research experience with individuals experiencing psychosis and their supporters. Dr. Emily Parsons, trained clinical psychologist and family therapist, will lead bi-weekly supervision calls to ensure appropriate care and support of Altitudes participants involved in this project, to discuss case conceptualization and suggestions for engaging individuals in the platform, as well as to monitor any potential safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants must be a parent, caregiver, or supporter of a young person who is currently receiving treatment from a CSC program for FEP or STEP clinic, on the waitlist to receive services from the CSC, who has recently graduated/discharged from a CSC program, or was referred to the study from the community (via Early Psychosis Interventions of North Carolina (EPI-NC) warm line, community psychiatrist/therapist, or inpatient/outpatient mental health services) where young person is experiencing psychosis but was not referred or enrolled in CSC
- •Parent, caregiver, or supporter must be > 18 years of age
- •Participants recruited from NC CSC programs (i.e., OASIS, SHORE, Encompass, Eagle, AEGIS, WeCare2), STEP programs, and the community screening process
- •Parent, caregiver, or supporter must have access to internet through a mobile phone, tablet, or computer
排除标准
- •Parent or caregiver is currently engaged in legal action against the loved one experiencing psychosis
- •Parent or caregiver does not speak and understand English as the platform, its moderation, interviews, and measures are available only in English
- •Parent, caregiver, or supporter is <18 years of age
研究组 & 干预措施
Altitudes Condition
Individuals whose loved ones are experiencing first-episode psychosis (FEP) and receiving services from OASIS, SHORE, Eagle, Encompass, AEGIS, and WeCare2), STEP programs, or community services will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months.
干预措施: Device: Altitudes USA (Device)
结局指标
主要结局
Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 15-item scale. Answers are on a 7-point Likert scale (1-7) with options "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 15 to 105 with higher scores reflecting better perceptions of their relationship with Altitudes moderators.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score
时间窗: [Time Frame: Month 3, Month 6]
The Working Alliance Inventory for Guided Internet Interventions (WAI-I) is a 12-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores are averaged across items and range from 1 to 5. Higher scores indicate greater therapeutic alliance.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Working Alliance Inventory for Guided Internet Interventions (WAI-I) task and goals subscale is an 8-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores are averaged across items and range from 1 to 5. Higher scores indicate greater agreement between the therapist and client on tasks and goals.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Working Alliance Inventory for Guided Internet Interventions (WAI-I) is a 4-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores are averaged across items and range from 1 to 5. Higher scores indicate stronger bond with the supporting therapist.
Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 4-item scale. Answers are on a 7-point Likert scale with options "Not at all true"\[1\], "Somewhat true"\[4\], "Very true"\[7\] with a sliding scale between answers. Possible scores range from 4 to 28. Higher scores indicate stronger perceived competence and ability in using the Altitudes platform.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Overall Impressions of Platform Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The overall impressions of the platform scale is three 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 3 to 21. Higher scores indicate better overall impressions of the Altitudes platform.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Perception of Other Platform Users Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The perception of other platform users subscale is four 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 4 to 28. Higher scores indicate better perception of interactions with other Altitudes participants.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The safety and confidentiality subscale is two 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 2 to 14. Higher scores indicate higher perceived safety and confidentiality when using the platform.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Moderation and Peer Support Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The moderation and peer support subscale is three 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 3 to 21. Higher scores indicate higher regard of the moderators and peer support on the Altitudes platform.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Ideas for Increased Engagement Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The ideas for increased engagement subscale is five 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 5 to 35. Each question has to be interrupted individually to assess of the subscale.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Barriers to Use Subscale
时间窗: [Time Frame: Month 3, Month 6]
The Altitudes Health Care Climate Questionnaire is a 20-item scale. The barriers to use subscale is six 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 6 to 42. Lower scores indicate less issues with barriers to engaging with the platform.
Mean Engagement With the Altitudes Platform
时间窗: [Up to Month 6]
The Altitudes platform passively collects engagement data, including the number of therapy material accessed, number of problem-solving discussion forums (i.e., "talk-it-outs"), and any posts, comments, or reactions (emojis to other users' posts/comments) made on the platform. The investigators will provide the means and standard deviations for these site usage categories throughout the study period.
次要结局
- Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in Generalized Anxiety Disorder 7-item (GAD-7) - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in Patient Health Questionnaire (PHQ) - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in Self-Compassion Scale: Short Form (SCS) - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in the Modified Psychosis Attitude Survey - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score([Time Frame: Baseline, up to Month 6])
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Emotion-Focused Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Avoidant-Focused Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Problem-Focused Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in Family Questionnaire of Expressed Emotion - Total Score([Time Frame: Baseline, Up to Month 6])
- Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale([Time Frame: Baseline, Up to Month 6])
- Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales([Time Frame: Baseline, Up to Month 6])