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Mindfulness for Mothers of Children With Disabilities

Primary Purpose

Parental Burnout, Caregiver Burnout

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Mindfulness and Compassionate Living Course (MCLC)
Usual care intervention
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parental Burnout focused on measuring parental burnout, meditation, mindfulness, self-compassion, stress level, parents of children with disability, autism, quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: mother of childern with disabilities Exclusion Criteria: substance abuse; participation in another therapeutic project or individual psychotherapy; antidepressant treatment.

Sites / Locations

  • Wroclaw University of Health and Sport Sciences
  • Jan Dlugosz University in Czestochowa
  • University of Silesia in Katowice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based teleintervention

Usual care intervention

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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").

Full Information

First Posted
November 9, 2022
Last Updated
March 17, 2023
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
University of Silesia in Katowice, Jan Dlugosz University in Czestochowa
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1. Study Identification

Unique Protocol Identification Number
NCT05620368
Brief Title
Mindfulness for Mothers of Children With Disabilities
Official Title
Mindfulness-Based Online Support Program for Mothers of Children With Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
University of Silesia in Katowice, Jan Dlugosz University in Czestochowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Parenthood is accompanied by significant mental and physical effort accompanied by different sources of long-term stress and encumbrance. The results of this research indicate serious difficulties in the functioning of parents of children with disabilities, such as pain, emotional and physical discomfort, anxiety, depression, and problems resulting from the realization of everyday life activities combined with the care of the child. They indicate how serious this crisis is and how important life constraints it brings to the individual and the social functioning of the family. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parental Burnout, Caregiver Burnout
Keywords
parental burnout, meditation, mindfulness, self-compassion, stress level, parents of children with disability, autism, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based teleintervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual care intervention
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Compassionate Living Course (MCLC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Families in Early Intervention Quality of Life (FEIQoL)
Description
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).
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Parental Burnout Measure (PBM-12)
Description
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).
Time Frame
7 minutes
Title
Self-Compassion Scale (SCS)
Description
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).
Time Frame
7 minutes
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
7 minutes
Title
Ego Resilience Scale (ER89)
Description
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").
Time Frame
7 minutes

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: mother of childern with disabilities Exclusion Criteria: substance abuse; participation in another therapeutic project or individual psychotherapy; antidepressant treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Sekułowicz, Professor
Organizational Affiliation
Wroclaw University of Health and Sport Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Krystyna Boroń-Krupińska, PhD
Organizational Affiliation
Wroclaw University of Health and Sport Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylwia Wrona, PhD
Organizational Affiliation
University of Silesia in Katowice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wroclaw University of Health and Sport Sciences
City
Wroclaw
State/Province
Lower Silesia
ZIP/Postal Code
51-612
Country
Poland
Facility Name
Jan Dlugosz University in Czestochowa
City
Częstochowa
State/Province
Upper Silesia
ZIP/Postal Code
42-200
Country
Poland
Facility Name
University of Silesia in Katowice
City
Katowice
State/Province
Upper Silesi
ZIP/Postal Code
40-007
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26311196
Citation
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Results Reference
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20686629
Citation
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.
Results Reference
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31191735
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.
Results Reference
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PubMed Identifier
31267283
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.
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Citation
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Results Reference
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Citation
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Citation
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Citation
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Mindfulness for Mothers of Children With Disabilities

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