Altitudes for Caregivers

Caregiver Burnout Clinical Trial

Official title:

Altitudes for Caregivers: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094647
• Other study ID #: 23-1676
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Elizabeth Fraser, MS
• Phone: 208-967-3976
• Email: erfraser[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

The control participants will not engage with the Altitudes platform. They will be recruited from the Eagle, Encompass, AEGIS, and We2Care clinics primarily with the option to recruit from OASIS and SHORE as well from the family therapy and/or multi-family groups. They will meet with research staff at three time points (baseline, 3 months, and 6 months) to complete a battery of measures that mirror the measures completed by the Altitudes participant group. Control participants will be compensated for meeting with research staff and completing the battery of measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Caregiver Stress
• Caregiver Wellbeing

Intervention

Device:
• Altitudes USA
Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, Up to Month 6
Other	Mean Change in the Posttraumatic Growth Inventory (PTGI) Score	The PTGI is a 25-item self-report measure that assesses five domains of personal growth that may follow a stressful encounter. Answers are on a 6-point scale ranging from 0 "I did not experience this" to 5 "I experienced this change to a very great degree." Total scores on this scale range from 0 to 125. Higher scores reflect more positive changes in an individual's life following a stressful experience.	Baseline, Up to 6 Months
Primary	Qualitative Summaries of Participant Experience in Post-Treatment Feedback	This qualitative data will be collected post-treatment from Altitudes participants. Focus groups and 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.	Up to 6 months
Primary	Quantitative Summaries of Participant Experience in Post-Treatment Feedback	This quantitative data will be collected post-treatment from Altitudes participants. Feedback forms will prompt participants to answer questions regarding their experience with the platform on a scale of 1 to 5, with higher scores reflecting a more positive experience. Frequency counts will be included here.	Up to 6 months
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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	Month 3, Month 6
Primary	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 mean and standard deviation scores for each site usage category, as well as a range, for the Altitudes group only. Depending on sample size, the investigators will categorize users in low or high engagement groups.	Baseline, Up to Month 12
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Primary	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.	Month 3, Month 6
Secondary	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.	Baseline, up to Month 6
Secondary	Mean Change in Multidimensional Scale of Perceived Social Support - Total Score [Alternative form for Altitudes participants, original form for control group]	The Multidimensional Scale of Perceived Social Support Survey is a 16-item scale. Answers are on a 7-point scale with options ranging from "very strongly disagree" to "very strongly agree". Possible scores range from 16 to 112. Higher scores reflect higher feelings of social support (more perceived social support).	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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 critical comments subscale consists of 10 items and is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The critical comments 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 critical comments with their loved one.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	Mean Change in General Health Questionnaire (GHQ) -12 Score - Total Score	The GHQ-12 is a 12-item scale. Answers are on a 4-point scale ranging from 0 "not at all" to 3 "much more than usual." Possible scores range from 0 to 36. Higher scores reflect worse outcomes (more frequent depressive symptoms).	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6
Secondary	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.	Baseline, Up to Month 6