Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094647
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-10-16
Brief Title:
Altitudes for Caregivers
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Altitudes for Caregivers A Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 supporters psychological status wellbeing and social support as measured via self-report questionnaires
Detailed 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 Carolinas 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 eg number of postscomments 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 ie 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 masters level clinicians andor graduate students with relevant clinicalresearch 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 andor 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
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 Carolinas 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 eg number of postscomments 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 ie 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 masters level clinicians andor graduate students with relevant clinicalresearch 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None