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Digital Support for Caregivers
N/A
Recruiting
Led By Kelsey R Ludwig, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Parent or caregiver does not speak and understand English
Parent, caregiver, or supporter is under 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [time frame: month 3, month 6]
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how helpful an online social media platform with therapeutic content, called Altitudes, can be for parents, caregivers, and supporters of young people with psychosis in North Carolina. The study
Who is the study for?
This trial is for caregivers and supporters of young people with psychosis in North Carolina. Participants should be involved in programs like CSC, STEP, or similar community services. The study aims to include up to 50 individuals who can commit to a 6-month period.
What is being tested?
The Altitudes USA digital platform is being tested for its feasibility and potential benefits. It's an online social media tool with therapeutic content designed to support caregivers by improving their psychological status, well-being, and social support.
What are the potential side effects?
Since this intervention involves a digital platform rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or stress from engaging with the content.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My caregiver or I do not speak or understand English.
Select...
My caregiver is younger than 18.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ [time frame: month 3, month 6]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[time frame: month 3, month 6]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total score
Mean change in Altitudes Perceived Competence Scale (A-PCS) - Total score
Mean change in Altitudes Usability Questionnaire (AUQ) - Barriers to use subscale
+9 moreSecondary study objectives
Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale
Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale
Mean Change in Family Questionnaire of Expressed Emotion - Total Score
+18 moreOther study objectives
Engagement with Services for Self and Loved One
Mean Change in the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Altitudes ConditionExperimental Treatment1 Intervention
Individuals whose loved ones are experiencing first-episode psychosis (FEP) and receiving services from OASIS, SHORE, Eagle, Encompass, AEGIS, and WeCare2), STEP programs, or community services will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,657 Total Patients Enrolled
North Carolina Department of Health and Human ServicesOTHER_GOV
14 Previous Clinical Trials
94,253 Total Patients Enrolled
Kelsey R Ludwig, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Diana Perkins, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
217 Total Patients Enrolled