Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Purpose: The purpose of the present study is to investigate the acceptability and feasibility of implementing a moderated online social media platform with therapeutic content, Altitudes, as a part of an adjunct services offered at first-episode psychosis (FEP) clinics across North Carolina, also known as coordinated specialty care (CSC) programs. Additionally, to further assess the secondary aims of impact on experiences, wellbeing, and support from the platform, the investigators will recruit a control group of caregivers and supporters from clinics that do not have access to or are piloting the digital platform. Participants: Thirty parent or caregiver and supporter participants from OASIS and SHORE CSC clinics will be recruited for the Altitudes condition and 30 caregiver or supporter participants from Eagle, Encompass, AEGIS, We2Care, OASIS, and SHORE clinics will be recruited for the control condition. Procedures (methods): All participants will be recruited over a 20-week to 28-week period at from the North Carolina's first episode psychosis (FEP) clinics. The Altitudes condition participants will be recruited from OASIS and SHORE, while the control participants will be recruited from the Eagle, Encompass, AEGIS, and We2Care in addition to OASIS and SHORE. Altitude participants will engaged with the digital platform, known as Altitudes, for approximately 6 months. Site usage information as well as feedback about their experience will be collected from these participants through the Altitudes platform. Site usage information (e.g., number of posts/comments made on the site, the number and types of 'Journeys' or 'Tracks' (psychoeducation and therapeutic content) completed by participants, etc.) will be collected automatically through the Altitudes platform. Before being given access to Altitudes, a research coordinator, family peer support specialist, or moderator will provide instructions and guidance for using the site (i.e., Altitudes onboarding). Experiences, wellbeing, and support measures will be collected at baseline, mid-treatment (~3 months) and post-treatment (~6 months) for the Altitudes participants. Additional feedback in the form of a qualitative interview will be collected from the Altitudes participants at the end of six months intervention. As Altitudes involves psychoeducational and therapeutic content, this platform is considered an adjunct to the clinical care provided to caregivers and supporters by FEP clinics. As such, Altitudes participants will not be compensated for their involvement in the platform. Site usage information will be collected automatically through the Altitudes site. However, Altitudes participants will be compensated for providing feedback about their experience with Altitudes as well as for completing other assessments. Finally, Altitudes will be monitored at least once daily by trained family peer support specialists, master's level clinicians, and/or graduate students with relevant clinical/research experience with individuals experiencing psychosis and their caregivers and supporters. Drs. David Penn and Kelsey Ludwig, trained clinical psychologists, will lead weekly supervision calls to ensure appropriate care and support of Altitudes participants involved in this project, to discuss case conceptualization and suggestions for engaging individuals in the platform, as well as to monitor any potential safety concerns. The control participants will not engage with the Altitudes platform. They will be recruited from the Eagle, Encompass, AEGIS, and We2Care clinics primarily with the option to recruit from OASIS and SHORE as well from the family therapy and/or multi-family groups. They will meet with research staff at three time points (baseline, 3 months, and 6 months) to complete a battery of measures that mirror the measures completed by the Altitudes participant group. Control participants will be compensated for meeting with research staff and completing the battery of measures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06094647
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Elizabeth Fraser, MS
Phone 208-967-3976
Email erfraser@unc.edu
Status Recruiting
Phase N/A
Start date January 15, 2024
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04936828 - Ecological Momentary Intervention for Stroke Caregivers' Psychological Support N/A
Active, not recruiting NCT05029193 - Effectiveness of Mindfulness After a Stroke N/A
Completed NCT04271046 - STAR Caregivers - Virtual Training and Follow-up N/A
Completed NCT04682535 - Daily Study of Caregiving Relationships and Health
Completed NCT04037501 - Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia N/A
Active, not recruiting NCT04548089 - Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial N/A
Completed NCT04626804 - Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community N/A
Not yet recruiting NCT04811807 - Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease
Completed NCT05150990 - Technology and Family Thriving Study N/A
Completed NCT05620368 - Mindfulness for Mothers of Children With Disabilities N/A
Recruiting NCT04143763 - Mobile Message Intervention for Stroke Caregivers' Psychological Support N/A
Completed NCT04150055 - mHealth Mindfulness for Dementia Caregivers N/A
Enrolling by invitation NCT04250103 - Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
Recruiting NCT04901637 - Musculoskeletal Problems in Caregivers of Stroke Survivors
Recruiting NCT04861610 - Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults N/A
Completed NCT06049043 - Testing Preliminary Effectiveness of a CHW Training Program to Support African American and Latino Male Caregivers N/A
Completed NCT04394260 - Equality in Caregiving: Facilitating Caregiver Mastery Among LGBT Caregivers of PLWD
Recruiting NCT04627662 - Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA N/A
Completed NCT04648098 - Effect of Post-stroke Discharge Training N/A
Completed NCT04838197 - Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients