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

NCT06271824 | Completed

• 1 other identifier: 23-1519
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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. 1.Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
2. 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?

Conditions

Stress; Caregiver Burden; Anxiety; Depressive Symptoms

Outcome Measures

Primary Outcomes (4)

• Percentage of participants who withdraw from course

  The study records will indicate withdrawal status (Yes or No) for each enrolled participant who has attended at least 1 intervention session; Calculated by: number who withdraw/total number enrolled X 100

  Across 6 weeks of intervention

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

  The study records will indicate weekly attendance at each session (Yes or No) for each enrolled participant who has attended at least 1 intervention session. Calculated by: number who attend at least 4 of 6 sessions/total number enrolled X 100

  Across 6 weeks of intervention

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

  The Theoretical Framework of Acceptability includes 7-items regarding intervention acceptability on a scale of 1 to 5, scores range 7-35, higher numbers indicate greater acceptability. This general acceptability item will be used to assess overall acceptability of the course. Calculated by: number of participants who endorse "acceptable" or "completely acceptable"/total number of respondents X 100

  6 weeks

• Percentage of intervention topics covered

  A research assistant in attendance will use a fidelity checklist to assess if intended topics are covered each session (Yes/No). Calculated by number of topics covered/total number of topics intended to be covered X 100

  Across 6 weeks of intervention

Secondary Outcomes (8)

• Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks

  Baseline and 6 weeks

• Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks

  Baseline and 6 weeks

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

  Baseline and 6 weeks

• Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks

  Baseline and 6 weeks

• Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks

  Baseline and 6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Live, online socio-emotional group course

Behavioral: Self-Compassion Based Resilient Caregiving Course

Interventions

Self-Compassion Based Resilient Caregiving Course BEHAVIORAL

The Resilience Habits for Caregivers Course is a live, online, weekly 6 session program lasting 1.5 hours per session. The structure contains didactics, group discussions, guided exercises, and practices facilitated by a certified self-compassion instructor. Topics covered include: (1) noticing and accepting emotions (including conflicting emotions); (2) cultivating curiosity and self-compassion; (3) relating skillfully to difficult thoughts; (4) savoring and gratitude practices.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Christine Lathren, MD

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: March 21, 2024
• Primary Completion: June 3, 2024
• Study Completion: June 7, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)