Altitudes for Caregivers

NCT06094647 | Completed Results FDA Device

• 1 other identifier: 23-1676
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

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)

• Qualitative Summaries of Participant Experience in Post-Treatment Feedback

  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.

  Up to 6 months

• 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. Reported value is the average value at month 6 minus the average value at month 3.

  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.

  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

  Month 3, Month 6

• Mean Engagement With the Altitudes Platform

  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.

  Baseline, Up to Month 6

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score

  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 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 Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale

  Baseline, Post Treatment (Month 6)

Other Outcomes (2)

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

  Baseline, Post Treatment (Month 6)

• Mean Change in the Posttraumatic Growth Inventory (PTGI) Score

  Baseline, Post Treatment (Month 6)

Study Arms (2)

Altitudes Condition

EXPERIMENTAL

Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) 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: Altitudes USA

Treatment as Usual

NO INTERVENTION

Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.

Interventions

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:

• 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

You may not qualify if:

• 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

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: Kelsey Ludwig, PhD
• Organization: University of North Carolina at Chapel Hill

kelsey_ludwig@med.unc.edu

919-962-1401

Study Officials

• David Penn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Diana Perkins, MD, MPH

  Univeristy of North Carolina, School of Medicine

  PRINCIPAL INVESTIGATOR

• Kelsey Ludwig, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: January 15, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-02

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)