Altitudes: A Digital Intervention to Support Caregivers
NCT Number: NCT06509100
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Care Burden|Care Giving Burden|Caregiver Burnout|Caregiver Stress|Caregiver Wellbeing|Support, Family
Interventions: DEVICE: Device: Altitudes USA
Sponsor: University of North Carolina, Chapel Hill
Collaborators: North Carolina Department of Health and Human Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-03
Completion Date: 2025-07-14
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

Summary:
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.

Primary Outcome Measures: Mean change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total score, 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., [Time Frame: Month 3, Month 6]|Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total score, 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., [Time Frame: Month 3, Month 6]|Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and goals subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Perceived Competence Scale (A-PCS) - Total score, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Overall impressions of platform subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Perception of other platform users subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Moderation and peer support subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Ideas for increased engagement subscale, 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., [Time Frame: Month 3, Month 6]|Mean change in Altitudes Usability Questionnaire (AUQ) - Barriers to use subscale, 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., [Time Frame: Month 3, Month 6]|Mean engagement with the Altitudes platform, The Altitudes platform passively collects engagement data, including the number of therapeutic pathways started and completed, as well as any posts or comments made on the platform. The investigators will provide the means for the site usage categories. Depending on the sample size, the investigators will categorize users into low or high-engagement groups. High engagement will be deemed as an average of at least one active day (posting on the community page, posting a talk-it-out) on the platform per week during the study period., [Up to Month 6]
Secondary Outcome Measures: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score, The MOS Social Support Survey is a 19-item scale. Answers are on a 5-point scale with options "none of the time", "a little of the time", "some of the time", "most of the time", and "all of the time". Possible scores range from 19 to 95. Higher scores reflect higher feelings of social support (more perceived social support). The MOS Social Support Survey is a part of the PhenX Toolkit., [Time Frame: Baseline, Up to Month 6]|Mean Change in Generalized Anxiety Disorder 7-item (GAD-7) - Total Score, The GAD-7 is an 7-item scale. Answers are on a 4-point scale (0 = not at all; 3 = nearly every day) Possible scores range from 0 to 21. Higher scores reflect worse anxiety)., [Time Frame: Baseline, Up to Month 6]|Mean Change in Patient Health Questionnaire (PHQ) - Total Score, The PHQ is an 8-item scale. Answers are on a 4-point scale (0 = not at all; 3 = nearly every day). Possible scores range from 0 to 24. Higher scores reflect a greater severity of depression., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale, The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The non-reactivity subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 with higher scores indicate more mindful non-reactivity to thoughts and feelings., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale, The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The non-judgemental subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 once appropriate items have been reversed scored with higher scores indicate more nonjudgmental thoughts towards their beliefs and feelings., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale, The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The mindful action subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 after appropriate items have been reversed scored with higher scores indicate more awareness around their actions and experiences., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale, The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The description subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 after reverse scoring of appropriate items with higher scores indicate more to describe their feelings and experiences., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale, The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The observation subscale is 3 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 3 to 15 with higher scores indicate more observational awareness., [Time Frame: Baseline, Up to Month 6]|Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score, The Five Facet Mindfulness Questionnaire: 24-item is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. It can be divided into five subscales: Observing, Describing, Acting in Awareness, Non-judging, and Non-reactivity. Answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 24 to 120 once necessary questions (i.e., negative) have been reversed scored. Higher scores indicate more mindfulness and self- awareness., [Time Frame: Baseline, Up to Month 6]|Mean change in Self-Compassion Scale: Short Form (SCS) - Total Score, The Self-Compassion Scale is a 12-item self-report questionnaire designed to measure an individual's self-compassion towards themselves as well as their feelings and emotions. It can be divided into six subscales with two questions for each: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Over-identified. Answers are on a 5- point scale ranging from 1 "Almost never" to 5 "Almost always." Total score is calculated by totaling the mean of each subscales and reversing the negative subscales (self-judgment, isolation, and over-identification) then taking the mean of the summed subscales. Possible scores range from 1 to 5 with higher scores indicate increased self-compassion., [Time Frame: Baseline, Up to Month 6]|Mean change in the Modified Psychosis Attitude Survey - Total Score, The Modified Psychosis Attitudes Survey is a 19-item self-report questionnaire designed to measure an individual's beliefs and attitude towards psychosis (e.g., identifying psychosis, interacting with individuals experiencing psychosis, etc.). The survey can be divided into 4 subscales: perceived confidence, optimism, fulfillment, and stress-vulnerability orientation. Answers range from "Very strongly disagree", "Strongly disagree", "Mildly disagree", "Neutral", "Mildly agree", "Strongly agree", "Very strongly agree". Total score is obtained with summing each question, after reverse scoring appropriate questions. Possible scores range from 19 to 133. Higher total score indicates an increased knowledge, optimism, and attitudes towards psychosis., [Time Frame: Baseline, Up to Month 6]|Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total score, The UCLA Loneliness scale is a 20-item scale. Answers are on a 4-point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit., [Time Frame: Baseline, up to Month 6]|Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Emotion-Focused Subscale, The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The emotion-focused subscale is 12 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 12 to 48. Higher scores on each reflect more frequent use of emotion focused coping., [Time Frame: Baseline, Up to Month 6]|Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Avoidant-Focused Subscale, The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The avoidant-focused subscale is 8 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 8 to 32. Higher scores on each reflect more frequent use of avoidance for coping., [Time Frame: Baseline, Up to Month 6]|Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Problem-Focused Subscale, The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The problem-focused subscale is 8 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 8 to 32. Higher scores on each reflect more frequent use of problem focused coping., [Time Frame: Baseline, Up to Month 6]|Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale, The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The EOI subscale consists of 10 items with each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The EOI subscale is scored by adding together the ratings from the individual items. Possible scores ranging from 10 to 40 with higher scores indicating greater levels of emotional overinvolvement with their loved one., [Time Frame: Baseline, Up to Month 6]|Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale, The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The subscale is 10-items and is rated on a 4-point scale (1 = never/very rarely; 4 = very often). It is scored by adding together the ratings from the individual items. Possible scores ranging from 10 to 40 with higher scores indicating greater levels of critical comments with their loved one., [Time Frame: Baseline, Up to Month 6]|Mean Change in Family Questionnaire of Expressed Emotion - Total Score, The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The FQ has two subscales: critical comments, and EOI. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by adding together the ratings from the individual items. Possible scores range from 20 to 80 with higher scores indicating greater levels of expressed emotion., [Time Frame: Baseline, Up to Month 6]|Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale, The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". The negative experience subscale is 52 items with possible scores range from 0 to 208. Higher scores reflect feeling less prepared to provide caregiving and more negative experiences in caregiving., [Time Frame: Baseline, Up to Month 6]|Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales, The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". The positive experience subscale is 14 items with possible scores range from 0 to 56. Higher scores indicate greater feelings of preparedness and experiences with caregiving., [Time Frame: Baseline, Up to Month 6]|Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score, The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". Possible scores range from 0 to 264 after appropriate items have been reversed scored. Higher scores indicate greater feelings of preparedness for caregiving whereas lower scores reflect feeling less prepared to provide caregiving., [Time Frame: Baseline, Up to Month 6]
Other Outcome Measures: Mean Change in the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5), The PCL-5 is a 20-item self-report measure of the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD). Included in the scale are four domains consistent with the four criteria of PTSD in DSM-5: Re-experiencing (criterion B), Avoidance (criterion C), Negative alterations in cognition and mood (criterion D), and Hyper-arousal (criterion E). Answers are on a 5-point scale including "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely" and with total scores ranging from 0 to 80. Higher scores on the PCL-5 reflect more severe trauma-related symptoms., [Time Frame: Baseline, Up to Month 6]|Engagement with Services for Self and Loved One, The Engagement with Services Measure was developed for this study to assess the change in access to services across time for both the family member and their loved one. The frequency of engagement will be evaluated in the various services across intervention timing., [Up to Month 6]