CompletedNot Applicable

Altitudes for Caregivers

United States24 participantsStarted 2024-01-15

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Qualitative Summaries of Participant Experience in Post-Treatment Feedback

Timeframe: Up to 6 months

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score

Timeframe: Month 3, Month 6

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale

Timeframe: Month 3, Month 6

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale

Timeframe: Month 3, Month 6

Mean Engagement With the Altitudes Platform

Timeframe: Baseline, Up to Month 6

Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score

Timeframe: Month 3, Month 6

Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score

Timeframe: Month 3, Month 6

Trial details

NCT IDNCT06094647

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

Results submitted2025-07-14

View on ClinicalTrials.gov More Care Burden trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Qualitative Summaries of Participant Experience in Post-Treatment Feedback

Timeframe: Up to 6 months

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score

Timeframe: Month 3, Month 6

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale

Timeframe: Month 3, Month 6

Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale

Timeframe: Month 3, Month 6

Mean Engagement With the Altitudes Platform

Timeframe: Baseline, Up to Month 6

Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score

Timeframe: Month 3, Month 6

Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score

Timeframe: Month 3, Month 6