N/A
N=17
Altitudes: A Digital Intervention to Support Caregivers
Care Burden · Care Giving Burden · Caregiver Burnout · Caregiver Stress · Caregiver Wellbeing
Bottom Line
View on ClinicalTrials.gov: NCT06509100 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score — 0.091 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device: Altitudes USA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score |
0.091 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score |
1.091 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale |
0.273 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale |
0.818 | — |
| PRIMARY Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score |
-0.545 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Overall Impressions of Platform Subscale |
0.455 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Perception of Other Platform Users Subscale |
-0.182 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality Subscale |
-0.182 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Moderation and Peer Support Subscale |
-0.455 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Ideas for Increased Engagement Subscale |
0.182 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Barriers to Use Subscale |
1.818 | — |
| PRIMARY Mean Engagement With the Altitudes Platform |
0.12; 1.71; 7.35; 3.12; 41.41 | — |
| SECONDARY Mean Change in Medical Outcomes Study (MOS) Social Support Survey - Total Score |
1.353 | — |
| SECONDARY Mean Change in Generalized Anxiety Disorder 7-item (GAD-7) - Total Score |
-0.588 | — |
| SECONDARY Mean Change in Patient Health Questionnaire (PHQ) - Total Score |
-1.118 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale |
0.294 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale |
0.235 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale |
-0.059 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale |
0.588 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale |
0.882 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score |
2.059 | — |
| SECONDARY Mean Change in Self-Compassion Scale: Short Form (SCS) - Total Score |
0.064 | — |
| SECONDARY Mean Change in the Modified Psychosis Attitude Survey - Total Score |
3.353 | — |
| SECONDARY Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score |
-2.588 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Emotion-Focused Subscale |
0.706 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Avoidant-Focused Subscale |
-0.471 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Problem-Focused Subscale |
0.059 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale |
-2.353 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale |
-1.294 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Total Score |
-3.647 | — |
| SECONDARY Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale |
-10.824 | — |
| SECONDARY Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales |
4.059 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06509100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.