Altitudes: A Digital Intervention to Support Caregivers

NCT06509100 | Completed Results FDA Device

• 1 other identifier: 24-1141
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Care Burden; Care Giving Burden; Caregiver Burnout; Caregiver Stress; Caregiver Wellbeing; Support, Family

Keywords

Digital Intervention; Social Media; Virtual Therapeutic Content; Virtual Educational Content; Supporters; Caregiving

Outcome Measures

Primary Outcomes (12)

• 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 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.

  [Up to Month 6]

Secondary Outcomes (20)

• 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]

Other Outcomes (1)

• Mean Change in the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)

  [Time Frame: Baseline, Up to Month 6]

Study Arms (1)

Altitudes Condition

EXPERIMENTAL

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.

Device: Device: Altitudes USA

Interventions

Device: Altitudes USA DEVICE

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.

Altitudes Condition

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: David Rauscher
• Organization: University of North Carolina at Chapel Hill

david_rauscher@med.unc.edu

828-405-0588

Study Officials

• Kelsey R Ludwig, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Diana Perkins, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 19, 2024
• Study Start: September 3, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Requesting investigator has appropriate approval (see above) and an executed data use/sharing agreement with UNC.

Locations

US (1)