Caregiver Burnout Clinical Trial
Official title:
Mindfulness-Based Online Support Program for Mothers of Children With Disabilities
Verified date | December 2022 |
Source | Wroclaw University of Health and Sport Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities.
Status | Completed |
Enrollment | 24 |
Est. completion date | February 28, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - mother of childern with disabilities Exclusion Criteria: - substance abuse; - participation in another therapeutic project or individual psychotherapy; - antidepressant treatment. |
Country | Name | City | State |
---|---|---|---|
Poland | Jan Dlugosz University in Czestochowa | Czestochowa | Upper Silesia |
Poland | University of Silesia in Katowice | Katowice | Upper Silesi |
Poland | Wroclaw University of Health and Sport Sciences | Wroclaw | Lower Silesia |
Lead Sponsor | Collaborator |
---|---|
Wroclaw University of Health and Sport Sciences | Jan Dlugosz University in Czestochowa, University of Silesia in Katowice |
Poland,
Allen AB, Leary MR. Self-Compassion, Stress, and Coping. Soc Personal Psychol Compass. 2010 Feb 1;4(2):107-118. doi: 10.1111/j.1751-9004.2009.00246.x. — View Citation
Bogels SM, Lehtonen A, Restifo K. Mindful Parenting in Mental Health Care. Mindfulness (N Y). 2010 Jun;1(2):107-120. doi: 10.1007/s12671-010-0014-5. Epub 2010 May 25. — View Citation
Bohadana G, Morrissey S, Paynter J. Self-Compassion in Mothers of Children with Autism Spectrum Disorder: A Qualitative Analysis. J Autism Dev Disord. 2021 Apr;51(4):1290-1303. doi: 10.1007/s10803-020-04612-2. — View Citation
Bohadana G, Morrissey S, Paynter J. Self-compassion: A Novel Predictor of Stress and Quality of Life in Parents of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Oct;49(10):4039-4052. doi: 10.1007/s10803-019-04121-x. — View Citation
Cousineau TM, Hobbs LM, Arthur KC. The Role of Compassion and Mindfulness in Building Parental Resilience When Caring for Children With Chronic Conditions: A Conceptual Model. Front Psychol. 2019 Aug 5;10:1602. doi: 10.3389/fpsyg.2019.01602. eCollection 2019. — View Citation
Duncan LG, Coatsworth JD, Greenberg MT. A model of mindful parenting: implications for parent-child relationships and prevention research. Clin Child Fam Psychol Rev. 2009 Sep;12(3):255-70. doi: 10.1007/s10567-009-0046-3. — View Citation
Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686. — View Citation
Friis AM, Johnson MH, Cutfield RG, Consedine NS. Kindness Matters: A Randomized Controlled Trial of a Mindful Self-Compassion Intervention Improves Depression, Distress, and HbA1c Among Patients With Diabetes. Diabetes Care. 2016 Nov;39(11):1963-1971. doi: 10.2337/dc16-0416. Epub 2016 Jun 22. — View Citation
Homan KJ, Sirois FM. Self-compassion and physical health: Exploring the roles of perceived stress and health-promoting behaviors. Health Psychol Open. 2017 Sep 14;4(2):2055102917729542. doi: 10.1177/2055102917729542. eCollection 2017 Jul-Dec. — View Citation
Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4. — View Citation
Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6. — View Citation
Robinson S, Hastings RP, Weiss JA, Pagavathsing J, Lunsky Y. Self-compassion and psychological distress in parents of young people and adults with intellectual and developmental disabilities. J Appl Res Intellect Disabil. 2018 May;31(3):454-458. doi: 10.1111/jar.12423. Epub 2017 Nov 9. — View Citation
Ten Hoopen LW, de Nijs PFA, Duvekot J, Greaves-Lord K, Hillegers MHJ, Brouwer WBF, Hakkaart-van Roijen L. Children with an Autism Spectrum Disorder and Their Caregivers: Capturing Health-Related and Care-Related Quality of Life. J Autism Dev Disord. 2020 Jan;50(1):263-277. doi: 10.1007/s10803-019-04249-w. — View Citation
Turnage D, Conner N. Quality of life of parents of children with Autism Spectrum Disorder: An integrative literature review. J Spec Pediatr Nurs. 2022 Oct;27(4):e12391. doi: 10.1111/jspn.12391. Epub 2022 Aug 20. — View Citation
Wang H, Wang Q, Hu X, Han ZR. Mindfulness and Stress Among Parents of Children with Autism Spectrum Disorder in China. J Autism Dev Disord. 2022 May;52(5):2035-2045. doi: 10.1007/s10803-021-05011-x. Epub 2021 May 29. — View Citation
Zessin U, Dickhauser O, Garbade S. The Relationship Between Self-Compassion and Well-Being: A Meta-Analysis. Appl Psychol Health Well Being. 2015 Nov;7(3):340-64. doi: 10.1111/aphw.12051. Epub 2015 Aug 26. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Families in Early Intervention Quality of Life (FEIQoL) | Families in Early Intervention Quality of Life (FEIQoL) questionnaire will be used for assessing the quality of life. Participants answer 40 items using a five-point Likert scale (1, 'poor' to 5, 'excellent') in the aspects of family life (24 items), and child's functioning (16 items). | 15 minutes | |
Secondary | Parental Burnout Measure (PBM-12) | Parental Burnout will be assessed with the Parental Burnout Measure (PBM-12) measures parental burnout in two dimensions: exhaustion and helplessness. Both dimensions are measured as a sum of 6 items, answered on a 4-point Likert scale (1, 'never' to 4, 'very often'). Fully satisfactory internal reliability indicators (Cronbach's alpha) were reached by all burnout measures - PBM-12 total score (.90), exhaustion subscale (.88), and helplessness sub-scale (.80). | 7 minutes | |
Secondary | Self-Compassion Scale (SCS) | To assess self-compassion we will use a polish adaptation of the Self-Compassion Scale (SCS). Items on the SCS use a five-point Likert scale to measure conformity (1, 'almost never' to 5, 'almost always'). The final SCS score ranges from 26 to 130. A higher score indicates a higher level of self-compassion. This scale has good internal consistency and test-retest reliability (.93). | 7 minutes | |
Secondary | Perceived Stress Scale (PSS-10) | The 10-item Perceived Stress Scale (PSS-10) will be used to measure self-reported stress. This scale includes 10 questions, with answers ranked using a 5-point Likert scale, and assesses stressful experiences and responses to stress over the previous 4 weeks. Scores range from 0 to 56, with higher scores indicating higher levels of perceived stress. | 7 minutes | |
Secondary | Ego Resilience Scale (ER89) | The Ego-Resiliency Scale (ER89) measures the construct of ego-resiliency, which refers to the dynamic capacity of an individual to modify a characteristic level of ego-control, in either direction, as a function of the demand characteristics of the environmental context, so as to preserve or enhance system equilibration. It consists of 14 items, each responded to on a 4-point scale (1 = "does not apply at all"; 2 = "applies slightly, if at all"; 3 = "applies somewhat"; and 4 = "applies very strongly"). | 7 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04936828 -
Ecological Momentary Intervention for Stroke Caregivers' Psychological Support
|
N/A | |
Active, not recruiting |
NCT05029193 -
Effectiveness of Mindfulness After a Stroke
|
N/A | |
Completed |
NCT04271046 -
STAR Caregivers - Virtual Training and Follow-up
|
N/A | |
Completed |
NCT04682535 -
Daily Study of Caregiving Relationships and Health
|
||
Completed |
NCT04037501 -
Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia
|
N/A | |
Active, not recruiting |
NCT04548089 -
Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) : A Waitlist Randomized Controlled Trial
|
N/A | |
Completed |
NCT04626804 -
Remember Stuff: A Dyadic-focused Technology to Support Persons With Alzheimer's Disease in the Community
|
N/A | |
Not yet recruiting |
NCT04811807 -
Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease
|
||
Completed |
NCT05150990 -
Technology and Family Thriving Study
|
N/A | |
Recruiting |
NCT04143763 -
Mobile Message Intervention for Stroke Caregivers' Psychological Support
|
N/A | |
Completed |
NCT04150055 -
mHealth Mindfulness for Dementia Caregivers
|
N/A | |
Enrolling by invitation |
NCT04250103 -
Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
|
||
Recruiting |
NCT04901637 -
Musculoskeletal Problems in Caregivers of Stroke Survivors
|
||
Recruiting |
NCT04861610 -
Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
|
N/A | |
Completed |
NCT06049043 -
Testing Preliminary Effectiveness of a CHW Training Program to Support African American and Latino Male Caregivers
|
N/A | |
Completed |
NCT04394260 -
Equality in Caregiving: Facilitating Caregiver Mastery Among LGBT Caregivers of PLWD
|
||
Recruiting |
NCT04627662 -
Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA
|
N/A | |
Completed |
NCT04648098 -
Effect of Post-stroke Discharge Training
|
N/A | |
Completed |
NCT04838197 -
Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients
|
||
Completed |
NCT04335110 -
Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology
|
N/A |