Altitudes for Caregivers: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Qualitative Summaries of Participant Experience in Post-Treatment Feedback
研究概览
简要总结
The objective of this study is to assess the acceptability and feasibility of Altitudes, a novel digital behavioral health and psychoeducational intervention for caregivers and supporters of individuals experiencing first episode psychosis. The investigators will evaluate acceptability and feasibility with up to 30 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, caregivers and supporters' engagement with the digital platform, and qualitative interviews with the Altitudes caregivers and supporters. The investigators will additional evaluate the impact of the platform on caregiver and supporter's psychological status, wellbeing, and social support, as measured via self-report questionnaires.
详细描述
Purpose: The purpose of the present study is to investigate the acceptability and feasibility of implementing a moderated online social media platform with therapeutic content, Altitudes, as a part of an adjunct services offered at first-episode psychosis (FEP) clinics across North Carolina, also known as coordinated specialty care (CSC) programs. Additionally, to further assess the secondary aims of impact on experiences, wellbeing, and support from the platform, the investigators will recruit a control group of caregivers and supporters from clinics that do not have access to or are piloting the digital platform.
Participants: Thirty parent or caregiver and supporter participants from OASIS and SHORE CSC clinics will be recruited for the Altitudes condition and 30 caregiver or supporter participants from Eagle, Encompass, AEGIS, We2Care, OASIS, and SHORE clinics will be recruited for the control condition.
Procedures (methods): All participants will be recruited over a 20-week to 28-week period at from the North Carolina's first episode psychosis (FEP) clinics. The Altitudes condition participants will be recruited from OASIS and SHORE, while the control participants will be recruited from the Eagle, Encompass, AEGIS, and We2Care in addition to OASIS and SHORE. Altitude 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. Additional feedback in the form of a qualitative interview will be collected from the Altitudes participants at the end of six months intervention.
As Altitudes involves psychoeducational and therapeutic content, this platform is considered an adjunct to the clinical care provided to caregivers and supporters by FEP clinics. 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 level clinicians, and/or graduate students with relevant clinical/research experience with individuals experiencing psychosis and their caregivers and supporters. Drs. David Penn and Kelsey Ludwig, trained clinical psychologists, will lead 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
- Non Randomized
- 干预模型
- Parallel
- 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
- •Parent, caregiver, or supporter of a young person who is currently receiving treatment from a CSC program for FEP, or who have recently graduated from a CSC program
- •Parent, caregiver, or supporter must be at least 18 years of age
- •Participants recruited from Outreach and Support Intervention Services (OASIS) & Supporting Hope, Opportunities, Recovery and Empowerment (SHORE; i.e., two CSC programs in NC), as this is a pilot study, or Eagle, Encompass, AEGIS, We2Care, SHORE, or OASIS clinics for participants part of the control group
- •Parent, caregiver, or supporter must have access to internet through a mobile phone, tablet, or computer
排除标准
- •Parent, caregiver, or supporter is currently engaged in legal action against the loved one receiving services from the CSC program
- •Parent, caregiver, or supporter does not speak English
- •Parent, caregiver, or supporter is under 18 years of age
结局指标
主要结局
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
时间窗: Up to 6 months
This qualitative data will be collected post-treatment from Altitudes participants. Individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality Subscale
时间窗: 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: 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 Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale
时间窗: 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 Altitudes Usability Questionnaire (AUQ) - Perception of Other Platform Users Subscale
时间窗: 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 Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score
时间窗: 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. Reported value is the average value at month 6 minus the average value at month 3.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Overall Impressions of Platform Subscale
时间窗: 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.
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
时间窗: Up to 6 months
This qualitative data will be collected post-treatment from Altitudes participants. Individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale
时间窗: 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 Engagement With the Altitudes Platform
时间窗: Baseline, Up to Month 6
The Altitudes platform passively collects engagement data, including the number of therapeutic education modules started and completed as well as any posts, reactions, or comments made on the platform. The investigators will provide mean and standard deviation scores for each site usage category, for the Altitudes group only. The data was collected continuously from baseline up to month 6 as a count of occurences with the mean engagement with the Altitudes platform computed across this time frame.
Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score
时间窗: 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 Altitudes Perceived Competence Scale (A-PCS) - Total Score
时间窗: 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) - Barriers to Use Subscale
时间窗: 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.
次要结局
- Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales(Baseline, Post Treatment (Month 6))
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Problem-Focused Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Multidimensional Scale of Perceived Social Support - Total Score [Alternative Form for Altitudes Participants, Original Form for Control Group](Baseline, Post Treatment (Month 6))
- Mean Change in Family Questionnaire of Expressed Emotion - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in General Health Questionnaire (GHQ) -12 Score - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Avoidant-Focused Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Emotion-Focused Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Self-Compassion Scale: Short Form (SCS) - Total Score(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale(Baseline, Post Treatment (Month 6))
- Mean Change in the Modified Psychosis Attitude Survey - Total Score(Baseline, Post Treatment (Month 6))