Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2021-10-01
2023-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities
NCT06557486
Health, Integration, Concentration: Mindfulness in Schools
NCT03141229
RCT: Mindfulness for Social Work and Self-care
NCT05538650
Psychological and Neurobiological Impact of a Retreat Based on Mindfulness and Compassion for Stress Reduction.
NCT05516355
Effectiveness of Mindfulness-Based Interventions on Professional Quality of Life, Work Engagement, and Sleep Quality
NCT06400381
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A parent's ability to adapt to stressful situations depends on several variables, including an individual's psychological strengths, individual and family resources, and the type of coping strategies utilized. Parental burnout is defined as a syndrome that occurs in response to chronic parental stress. The risk of parental burnout is related to family functioning. In the concept of family as an interactional system, "family adaptability is the degree to which the family is flexible and can regain equilibrium in stressful and challenging situations or environments".
Positive coping styles such as positive perceptions and effective problem-solving skills were associated with successful family adaptation and resilience. Twenty years ago, the concept of mindful parenting was introduced as an alternative to traditional discipline-oriented methods by focusing on the quality of a parent's presence in the parent-child dyad. It focuses on cultivating mindfulness and attunement with the parent's inner experience while interacting with the child, and feeling the full range of emotions related to parenting. Mindful parenting involves cultivating non-judgmental awareness of the unfolding of internal and external experiences in daily life, practicing emotion regulation skills, learning about adaptive responses to distress, and developing a self-compassionate attitude toward one's fallibility, limitations, and suffering.
Compassion- and mindfulness-based interventions (CMBIs) hold promise in supporting parental resilience by enabling adaptive stress appraisal and coping, mindful parenting, and self-compassion. These interventions also aimed to reduce social isolation by increasing the capacity for connections. Perceived social support, an aspect of compassionate behavior, is a potent buffer against stress on health outcomes.
Therefore, 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. The investigators hypothesize that the mindfulness-based teleintervention compared with the control group will lead to (A) an improvement in positive aspects of mental health, including quality of life, and self-compassion, and (B) a reduction in psychopathological variables including perceived stress and parental burnout.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness-based teleintervention
8-week Mindfulness and Compassionate Living Course (MCLC). The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours).
Mindfulness and Compassionate Living Course (MCLC)
The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours) between sessions 6 and 7.
On the structural level, every course session consists of four elements: (1) an educational input, (2) mindfulness and compassion exercises (eg, sitting meditation, body scan, mindful walking, self-compassion break), (3) a reflection of one's practice (inquiry), (4) and home assignments.
Usual care intervention
The facility provides psychological support for parents as needed and at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).
Usual care intervention
If necessary, psychological support is organized at the request of the parent.
Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness and Compassionate Living Course (MCLC)
The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours) between sessions 6 and 7.
On the structural level, every course session consists of four elements: (1) an educational input, (2) mindfulness and compassion exercises (eg, sitting meditation, body scan, mindful walking, self-compassion break), (3) a reflection of one's practice (inquiry), (4) and home assignments.
Usual care intervention
If necessary, psychological support is organized at the request of the parent.
Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* participation in another therapeutic project or individual psychotherapy;
* antidepressant treatment.
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Silesia in Katowice
UNKNOWN
Jan Dlugosz University in Czestochowa
OTHER
Wroclaw University of Health and Sport Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Błażej Cieślik
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Małgorzata Sekułowicz, Professor
Role: STUDY_CHAIR
Wroclaw University of Health and Sport Sciences
Krystyna Boroń-Krupińska, PhD
Role: PRINCIPAL_INVESTIGATOR
Wroclaw University of Health and Sport Sciences
Sylwia Wrona, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Silesia in Katowice
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wroclaw University of Health and Sport Sciences
Wroclaw, Lower Silesian Voivodeship, Poland
Jan Dlugosz University in Czestochowa
Częstochowa, Upper Silesia, Poland
University of Silesia in Katowice
Katowice, Upper Silesi, Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01/2021
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.