Clinical trial NCT06271824: Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities
Official title: Developing and Piloting a Tailored Self-Compassion Program to Enhance the Well-Being of Informal Caregivers of Children With Physical Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Caregiver Burden
Anxiety
Depressive Symptoms
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Caregiver is at least 18 years old
* Caregiver reads and speaks in English
* Caregiver is a primary caregiver to a child aged 2-17 with a moderate to severe chronic physical disability (child requires assistance or adapted methods for mobility (e.g., walking, transfers) and at least 1 other functional area (e.g., toileting, feeding, communication))

Exclusion Criteria:

* Caregiver has no access to the internet/Zoom
* Caregiver has been hospitalized in the last year for mental health treatment
* Caregiver has a history of psychosis (e.g., schizophrenia)
* Caregiver will miss 2 or more class sessions due to scheduling conflicts

Primary outcomes:
measure: Percentage of participants who withdraw from course
timeFrame: Across 6 weeks of intervention
measure: Percentage of participants who attend at least 4 of 6 intervention sessions
timeFrame: Across 6 weeks of intervention
measure: Percentage of participants who rate the course as "acceptable" or "completely acceptable"
timeFrame: 6 weeks
measure: Percentage of intervention topics covered
timeFrame: Across 6 weeks of intervention
Secondary outcomes:
measure: Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carollina at Chapel Hill
name: Christine Lathren, MD
role: PRINCIPAL_INVESTIGATOR
References: