University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT06271824
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Across 6 weeks of intervention
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
Time frame: Across 6 weeks of intervention
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
Time frame: 6 weeks
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
Time frame: Across 6 weeks of intervention
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
Time frame: Baseline and 6 weeks
The PSS is a validated 10 item scale assessing the degree to which situations in one's life are perceived as stressful assessed over the last 7 days; scale ranges from 0=never to 4=very often; total scores range from 0 to 40 with higher scores indicating higher stress.
Time frame: Baseline and 6 weeks
The Connor-Davidson Resilience Scale is an 10-item measure of resilience and hardiness. Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4, total scores range from 0 to 40, and higher scores indicate higher resilience.
Time frame: Baseline and 6 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1. 0 - Anxiety 7a questionnaire includes 7 questions related to anxious mood in the past 7 days. Each question is rated on a five-point scale from 1=Never to 5=Always, with total scores ranging from 7-35 and higher scores indicating higher anxiety levels.
Time frame: Baseline and 6 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Depression scale measures depressive symptoms in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Time frame: Baseline and 6 weeks
The SCS-SF is a 12 item scale that measures how often one is self-compassionate. Each item is rated on a 5-point scale from 1=almost never to 5=almost always with a range in score from 8 to 40 with higher scores indicating greater frequency of self-compassion.
Time frame: Baseline and 6 weeks
The ZBI-12 is a 12 item scale measuring caregiver burden. Each item is rated from 0 (never) to 4 (nearly always) with a range from 0 to 48 and higher scores indicating higher burden.
Time frame: Baseline and 6 weeks
The Uplifts subscale measures positive aspects of caregiving using 6 items answered in a 5-point response scale ranging from 1 (Not at all) to 5 (A great deal). Scores range from 6-30, with higher scores indicating higher degrees of positive experiences in caregiving.
Time frame: Baseline and 6 weeks
The Difficulties in Emotion Regulation scale measures difficulties with regulation of emotions using 18-items representing 6 subscales (strategies, nonacceptance, impulse, goals, awareness and clarity) answered in a 5-point response scale ranging from 1 (Almost never) to 5 (almost always). Total scores range from 18- 90 with higher scores indicating higher levels of difficulty with emotion regulation.
University of North Carolina, Chapel Hill
Other
Developing and Piloting a Tailored Self-Compassion Program to Enhance the Well-Being of Informal Caregivers of Children With Physical Disabilities
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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