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Behavioral Intervention

Intervention for Depression

N/A

Recruiting

Led By Christine Lathren, MD

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

At least 18 years old

Is the primary caregiver to a child aged 2-17 with a chronic physical disability that requires assistance in at least 2 functional areas (e.g., mobility, self-care, communication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial aims to see if an online self-compassion-based resilience course can help caregivers of children with physical disabilities. The trial will test if the course is helpful and if it improves caregiver stress,

Who is the study for?

This trial is for caregivers of children with physical disabilities who are experiencing stress, anxiety, or depression. Participants should be willing to engage in an online self-compassion course and complete surveys before and after the course.Check my eligibility

What is being tested?

The study tests a tailored online self-compassion-based resilience course designed to improve well-being. Caregivers will attend a 6-session weekly program led by a certified instructor, aiming to enhance coping skills and life satisfaction.See study design

What are the potential side effects?

There may not be direct side effects from participating in this type of psychological intervention; however, discussing sensitive topics could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I care for a child with a disability needing help in 2 or more daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of intervention topics covered

Percentage of participants who attend at least 4 of 6 intervention sessions

Percentage of participants who rate the course as "acceptable" or "completely acceptable"

+1 more

Secondary outcome measures

Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks

Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks

Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Live, online socio-emotional group course

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,813 Total Patients Enrolled

54 Trials studying Depression

33,686 Patients Enrolled for Depression

Christine Lathren, MDPrincipal InvestigatorUniversity of North Carollina at Chapel Hill

Frequently Asked Questions

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

What are the main goals that this clinical trial aims to achieve?

"The primary goal of this clinical investigation, to be assessed over a period spanning approximately 6 weeks of active treatment, is the proportion of participants engaging in at least 4 out of the total 6 intervention sessions. Secondary assessments encompass variations in Perceived Stress levels as detected by the Perceived Stress Scale (PSS-10 item) after 6 weeks. The PSS evaluates one's perception of stressfulness within their recent life events on a scale from never (0) to very often (4), with cumulative scores ranging between 0 and 40 indicating escalating stress levels. Additionally, alterations in Resilience will be examined using the"

Answered by AI

Are potential candidates still eligible to participate in this ongoing clinical trial?

"As per data from clinicaltrials.gov, this particular study is currently not in the recruitment phase. The trial information was made available on April 1st, 2024 and last modified on February 14th, 2024. Despite this trial no longer seeking participants, there are a total of 1613 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities

2024. "Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06271824.

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