protocolSection identificationModule nctId: NCT06271824, orgStudyIdInfo id: 23-1519, briefTitle: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the feasibility, acceptability and preliminary social/emotional well-being outcomes of a tailored, online self-compassion-based resilience course for caregivers of children with physical disabilities. The main questions it aims to answer are:1. Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?2. Is participation in the resilience course associated with improvements in caregiver stress, anxiety, depression, burden, caregiver uplifts, self-compassion, emotion regulation and/or resilience?Participants will complete a screening, a verbal consent process and an electronic pre-course survey. Then, they will participate in a 6-session weekly online course with other caregivers and led by a certified Mindful Self-Compassion instructor. The course has been created with feedback from caregivers and includes skills for recognizing and coping with difficult emotions while connecting with others who have similar caregiving experiences. After the course, participants will repeat the electronic survey and will provide feedback on the course during a live, online feedback session., conditionsModule conditions: Stress, conditions: Caregiver Burden, conditions: Anxiety, conditions: Depressive Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Self-Compassion Based Resilient Caregiving Course, outcomesModule primaryOutcomes measure: Percentage of participants who withdraw from course, primaryOutcomes measure: Percentage of participants who attend at least 4 of 6 intervention sessions, primaryOutcomes measure: Percentage of participants who rate the course as "acceptable" or "completely acceptable", primaryOutcomes measure: Percentage of intervention topics covered, secondaryOutcomes measure: Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks, secondaryOutcomes measure: Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks, secondaryOutcomes measure: Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks, secondaryOutcomes measure: Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks, secondaryOutcomes measure: Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks, secondaryOutcomes measure: Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks, secondaryOutcomes measure: Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks, secondaryOutcomes measure: Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Monica Coudurier, role: CONTACT, email: m_coudurier@unc.edu, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False