StressNCT06271824
Self-Compassion to Enhance the Well-Being of Caregivers of Children With Physical Disabilities
A study testing Self-Compassion Based Resilient Caregiving Course in people with Stress and Caregiver Burden, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Caregiver Burden, Anxiety
- What is being tested?
- Self-Compassion Based Resilient Caregiving Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Developing and Piloting a Tailored Self-Compassion Program to Enhance the Well-Being of Informal Caregivers of Children With Physical Disabilities
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:
- Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
- 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.
- Conditions
- Stress, Caregiver Burden, Anxiety, Depressive Symptoms
- Being tested
- Self-Compassion Based Resilient Caregiving Course
- Medical subject headings
- Caregiver Burden, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion Based Resilient Caregiving CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Live, online socio-emotional group course Receives: Behavioral: Self-Compassion Based Resilient Caregiving Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: Baseline and 6 weeks
Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 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.
Measured: Baseline and 6 weeks
Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 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.
Measured: Baseline and 6 weeks
Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 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.
Measured: Baseline and 6 weeks
Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 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.
Measured: Baseline and 6 weeks
Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 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.
Measured: Baseline and 6 weeks
Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 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.
Measured: Baseline and 6 weeks
Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start21 Mar 2024
- Primary completion3 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Lathren, MD, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271824
- Sponsor's protocol ID
- 23-1519
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Piloting a Tailored Self-Compassion Program to Enhance the Well-Being of Informal Caregivers of Children With Physical Disabilities
- ClinicalTrials.gov ID
- NCT06271824
- Acronym / sponsor ID
- 23-1519
- Conditions
- Stress, Caregiver Burden, Anxiety, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the online resilience course feasible and acceptable to caregivers of children with physical disabilities?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Self-Compassion Based Resilient Caregiving CourseLive, online socio-emotional group course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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))
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Compassion Based Resilient Caregiving CourseThe 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. | Behavioural | Intervention |
Primary outcome
Percentage of participants who withdraw from course
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
Percentage of participants who attend at least 4 of 6 intervention sessions
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
Percentage of participants who rate the course as "acceptable" or "completely acceptable"
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
Percentage of intervention topics covered
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
8 secondary outcomes
Mean Change in Perceived Stress as Measured by the Perceived Stress Scale (PSS-10 item) at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Resilience as measured by the Connor-Davidson Resilience Scale-10 at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Anxiety as measured by the PROMIS-SF 7-item Anxiety Scale at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Depressive symptoms as measured by the PROMIS-SF 8-item Depression Scale at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Self-Compassion as measured by the Self-Compassion Scale-Short form (SCS-SF) at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Caregiver Burden as measured by the 12-item Zarit Caregiver Burden Scale (ZBI-12) at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Caregiver Uplifts as measured by the Uplifts subscale of the Revised Burden Measure at 6 weeks
Time frame: Baseline and 6 weeks
Mean Change in Difficulties with Emotion Regulation as measured by the Difficulties in Emotion Regulation-Short Form Scale
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Lathren, MD principal investigator
University of North Carollina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion Based Resilient Caregiving Course in people with Stress and Caregiver Burden, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who withdraw from course (time frame: Across 6 weeks of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.