Clinical trial NCT06509100: Altitudes: A Digital Intervention to Support Caregivers
Official title: Altitudes: A Blended Digital Health Intervention to Support Caregivers and Other Supporters of Young People With Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Care Burden
Care Giving Burden
Caregiver Burnout
Caregiver Stress
Caregiver Wellbeing
Support, Family
Keywords: Digital Intervention
Social Media
Virtual Therapeutic Content
Virtual Educational Content
Supporters
Caregiving
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Department of Health and Human Services
First posted: 2024-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 supporter's 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 Carolina's 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 (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. 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, master's or Ph.D. level clinicians, and/or graduate students with relevant clinical/research 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.

Eligibility criteria: Inclusion Criteria:

* The participants must be a parent, caregiver, or supporter of a young person who is currently receiving treatment from a CSC program for FEP or STEP clinic, on the waitlist to receive services from the CSC, who has recently graduated/discharged from a CSC program, or was referred to the study from the community (via Early Psychosis Interventions of North Carolina (EPI-NC) warm line, community psychiatrist/therapist, or inpatient/outpatient mental health services) where young person is experiencing psychosis but was not referred or enrolled in CSC
* Parent, caregiver, or supporter must be \> 18 years of age
* Participants recruited from NC CSC programs (i.e., OASIS, SHORE, Encompass, Eagle, AEGIS, WeCare2), STEP programs, and the community screening process
* Parent, caregiver, or supporter must have access to internet through a mobile phone, tablet, or computer

Exclusion Criteria:

* Parent or caregiver is currently engaged in legal action against the loved one experiencing psychosis
* Parent or caregiver does not speak and understand English as the platform, its moderation, interviews, and measures are available only in English
* Parent, caregiver, or supporter is \<18 years of age

Primary outcomes:
measure: Mean change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total score
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total score
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and goals subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Perceived Competence Scale (A-PCS) - Total score
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Overall impressions of platform subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Perception of other platform users subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Moderation and peer support subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Ideas for increased engagement subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Barriers to use subscale
timeFrame: [Time Frame: Month 3, Month 6]
measure: Mean engagement with the Altitudes platform
timeFrame: [Up to Month 6]
Secondary outcomes:
measure: Mean Change in Medical Outcomes Study (MOS) Social Support Survey - total score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in Generalized Anxiety Disorder 7-item (GAD-7) - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in Patient Health Questionnaire (PHQ) - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in Self-Compassion Scale: Short Form (SCS) - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean change in the Modified Psychosis Attitude Survey - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total score
timeFrame: [Time Frame: Baseline, up to Month 6]
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Emotion-Focused Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Avoidant-Focused Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Problem-Focused Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in Family Questionnaire of Expressed Emotion - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score
timeFrame: [Time Frame: Baseline, Up to Month 6]
Other outcomes:
measure: Mean Change in the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)
timeFrame: [Time Frame: Baseline, Up to Month 6]
measure: Engagement with Services for Self and Loved One
timeFrame: [Up to Month 6]
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kelsey R Ludwig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Diana Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: