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Digital Support Program for Caregiver Burnout

N/A

Recruiting

Led By David Penn, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3, month 6

Awards & highlights

Study Summary

This trial will evaluate the effectiveness of a digital program to support caregivers and supporters of individuals with first episode psychosis. It will measure acceptability and usability, psychological status, wellbeing, and social support.

Who is the study for?

This trial is for parents or caregivers over 18 years old who support a young person currently in treatment or recently graduated from certain care programs (CSC) for first episode psychosis. They must have internet access and be recruited from specific clinics in NC. Those involved in legal action against their loved one, non-English speakers, or under 18 cannot join.Check my eligibility

What is being tested?

The study tests 'Altitudes', a digital intervention aimed at improving the wellbeing of caregivers supporting individuals with first episode psychosis. It will measure how well caregivers like and use the platform, and its effect on their psychological status and social support over six months.See study design

What are the potential side effects?

Since this is a digital behavioral health intervention focusing on education and support without medical treatments, there are no direct physical side effects expected as part of this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

+11 more

Secondary outcome measures

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

+17 more

Other outcome measures

Mean Change in the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)

Mean Change in the Posttraumatic Growth Inventory (PTGI) Score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Altitudes ConditionExperimental Treatment1 Intervention

Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) 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.

Group II: Treatment as UsualActive Control1 Intervention

Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,982 Total Patients Enrolled

North Carolina Department of Health and Human ServicesOTHER_GOV

13 Previous Clinical Trials

131,905 Total Patients Enrolled

David Penn, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

3 Previous Clinical Trials

176 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can persons aged 18 and over participate in this research?

"According to the trial's inclusion criteria, individuals aged 18 or older are eligible for participation and those over 99 will not be accepted."

Answered by AI

Is this trial actively recruiting new participants?

"Data on clinicaltrials.gov reveals that, although it was originally posted in January 2024 and last updated in October 2023, this trial is no longer recruiting patients. However, there are 80 other studies currently searching for participants across the United States of America."

Answered by AI

Is my inclusion in this experiment feasible?

"In order to qualify for the trial, individuals must demonstrate symptoms of caregiver burnout and fit within the age range of 18-99. This clinical study is currently looking to admit 60 participants in total."

Answered by AI

What main goals are researchers expecting to achieve with this experiment?

"The primary purpose of this trial, which is expected to span up to 6 months, involves compiling quantitative summaries from participant post-treatment feedback. Secondary objectives include measuring changes in social support scores (MSPSS), preparedness for caregiving (ECI) and positive experiences with caregiving via the ECI subscales."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Altitudes for Caregivers

2024. "Altitudes for Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094647.