N/A
N=24
Altitudes for Caregivers
Care Burden · Care Giving Burden · Caregiver Burnout · Caregiver Stress · Caregiver Wellbeing
Bottom Line
View on ClinicalTrials.gov: NCT06094647 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Qualitative Summaries of Participant Experience in Post-Treatment Feedback — 17; 17; 14; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Altitudes USA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Summaries of Participant Experience in Post-Treatment Feedback |
17; 17; 14; 9; 18; 15 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score |
0.27 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale |
0.23 | — |
| PRIMARY Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale |
0.35 | — |
| PRIMARY Mean Engagement With the Altitudes Platform |
2.92; 9.79; 21.13; 1.88; 0.29; 3.54 | — |
| PRIMARY Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score |
0.12 | — |
| PRIMARY Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score |
0.19 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Overall Impressions of Platform Subscale |
0.50 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Perception of Other Platform Users Subscale |
0.30 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality Subscale |
0.25 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Moderation and Peer Support Subscale |
0.18 | — |
| PRIMARY Mean Change in Altitudes Usability Questionnaire (AUQ) - Barriers to Use Subscale |
0.53 | — |
| SECONDARY Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score |
0.01 | — |
| SECONDARY Mean Change in Multidimensional Scale of Perceived Social Support - Total Score [Alternative Form for Altitudes Participants, Original Form for Control Group] |
0.01 | — |
| SECONDARY Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score |
2.54 | — |
| SECONDARY Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales |
3.73 | — |
| SECONDARY Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale |
1.34 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Total Score |
0.05 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale |
0.14 | — |
| SECONDARY Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale |
-0.10 | — |
| SECONDARY Mean Change in General Health Questionnaire (GHQ) -12 Score - Total Score |
-0.48 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Problem-Focused Subscale |
0.46 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Avoidant-Focused Subscale |
0.48 | — |
| SECONDARY Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Emotion-Focused Subscale |
1.18 | — |
| SECONDARY Mean Change in Self-Compassion Scale: Short Form (SCS) - Total Score |
0.33 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score |
-0.47 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale |
-.039 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale |
-0.50 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale |
-0.06 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale |
0.42 | — |
| SECONDARY Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale |
0.08 | — |
| SECONDARY Mean Change in the Modified Psychosis Attitude Survey - Total Score |
-0.01 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06094647). 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.