Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509100
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Altitudes A Digital Intervention to Support Caregivers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Altitudes A Blended Digital Health Intervention to Support Caregivers and Other Supporters of Young People With Psychosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 supporters psychological status well-being and social support as measured via self-report questionnaires
Detailed Description:
Purpose 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 CSC programs STEP programs and other community services where caregivers or supporters of young persons experiencing psychosis receive care
Participants Fifty parent or supporter participants from CSC clinics OASIS SHORE Eagle Encompass AEGIS and WeCare2 STEP programs or community services will be recruited for Altitudes
Procedures methods All participants will be recruited over a 20-week to 28-week period at from the North Carolinas community services 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 As Altitudes involves psychoeducational and therapeutic content this platform is considered an adjunct to care parents and supporters may be receiving 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 or PhD level clinicians andor graduate students with relevant clinicalresearch experience with individuals experiencing psychosis and their supporters Dr Emily Parsons trained clinical psychologist and family therapist will lead bi-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
Participants Fifty parent or supporter participants from CSC clinics OASIS SHORE Eagle Encompass AEGIS and WeCare2 STEP programs or community services will be recruited for Altitudes
Procedures methods All participants will be recruited over a 20-week to 28-week period at from the North Carolinas community services 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 As Altitudes involves psychoeducational and therapeutic content this platform is considered an adjunct to care parents and supporters may be receiving 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 or PhD level clinicians andor graduate students with relevant clinicalresearch experience with individuals experiencing psychosis and their supporters Dr Emily Parsons trained clinical psychologist and family therapist will lead bi-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None