Clinical trial NCT06094647: Altitudes for Caregivers
Official title: Altitudes for Caregivers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2023-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 supporter's 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Qualitative Summaries of Participant Experience in Post-Treatment Feedback
timeFrame: Up to 6 months
measure: Quantitative Summaries of Participant Experience in Post-Treatment Feedback
timeFrame: Up to 6 months
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total score
timeFrame: Month 3, Month 6
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and goals subscale
timeFrame: Month 3, Month 6
measure: Mean change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond subscale
timeFrame: Month 3, Month 6
measure: Mean engagement with the Altitudes platform
timeFrame: Baseline, Up to Month 12
measure: Mean change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total score
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Perceived Competence Scale (A-PCS) - Total score
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Overall impressions of platform subscale
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Perception of other platform users subscale
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality subscale
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Moderation and peer support subscale
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Ideas for increased engagement subscale
timeFrame: Month 3, Month 6
measure: Mean change in Altitudes Usability Questionnaire (AUQ) - Barriers to use subscale
timeFrame: Month 3, Month 6
Secondary outcomes:
measure: Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total score
timeFrame: Baseline, up to Month 6
measure: Mean Change in Multidimensional Scale of Perceived Social Support - Total Score [Alternative form for Altitudes participants, original form for control group]
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean Change in Family Questionnaire of Expressed Emotion - Total Score
timeFrame: Baseline, Up to Month 6
measure: Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean Change in General Health Questionnaire (GHQ) -12 Score - Total Score
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Problem-Focused Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Avoidant-Focused Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) scale - Emotion-Focused Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in Self-Compassion Scale: Short Form (SCS) - Total Score
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale
timeFrame: Baseline, Up to Month 6
measure: Mean change in the Modified Psychosis Attitude Survey - Total Score
timeFrame: 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: Baseline, Up to Month 6
measure: Mean Change in the Posttraumatic Growth Inventory (PTGI) Score
timeFrame: Baseline, Up to 6 Months
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: David Penn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of North Carolina, School of Medicine
name: Diana Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: