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The Effect of Mindfulness-Based Self-Compassion Education Given to Parents of Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-Based Self-Compassion Education
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Awareness, well-being, self-compassion, resilience, stress

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To be at least a primary school graduate. Being the parent of a child whose age is 7-12 and diagnosed with ASD. Willingness to participate in the study. To be open to communication and cooperation. Exclusion Criteria: Parental psychiatric problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient Education Booklet

    Arm Description

    Before applying to the parents of the children with ASD included in the experimental group, After the pre-test data are collected, 8 sessions of Awareness-Based Self-Compassion training will be given to the parents in the experimental group. The first two sessions will be held face-to-face, and the remaining sessions will continue online. Each session will be planned for 3 days to 7 days for its activity and continuity. One week after the Awareness-Based Self-Compassion training (after 8 sessions were completed), parents were given the "Parental Stress Scale (PASS)", "Adult Resilience Scale", "Warwick-Edinburgh Mental Well-Being Scale", "Self-Compassion Scale". Short Form (SSS-F)", "Conscious Awareness Scale (CIFS)" post-test will be filled face to face.

    Outcomes

    Primary Outcome Measures

    Parental Stress Scale (PASS)
    It was developed by Özmen and Özmen (2012) to measure the stress experienced by mothers and fathers in their relationships with their children in daily life. ABSQ consists of a single factor structure consisting of 16 items. The Cronbach alpha coefficient of the scale is .85. The scale is a four-point Likert type (Always=4, Often=3, Sometimes=2, Never=1). The lowest score that can be obtained from the scale is 16, and the highest score is 64. A high score from the scale indicates that parental stress is high.
    Resilience Scale for Adults
    The dimensions in the scale are called 'self-perception', 'perception of the future', 'structural style', 'social competence', 'family cohesion' and 'social resources'. In the scale, which includes a total of 33 items, a format is used in which positive and negative features are on different sides, and five separate boxes are used for answers in order to avoid biased evaluations in choosing the items. In the schematic evaluation, the scoring method was released in the high or low measurement of psychological resilience.Cronbach Alpha values calculated for the reliability of the scale; It was calculated as 0.76 for 'Self Perception', 0.75 for 'Future Perception', 0.84 for 'Social Competence', 0.89 for 'Family Cohesion', 0.80 for 'Social Resources' and 0.76 for 'Structural Style.
    Warwick-Edinburgh Mental Well-Being Scale
    Tennant et al. (2007) and adapted into Turkish by Keldal (2015). Consisting of 14 items and a single dimension, this scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a 5-point Likert type, with a scoring of 1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree. A minimum of 14 and a maximum of 70 points are obtained from the scale. High scores obtained from the scale indicate high mental (psychological) well-being. All items of the scale are positive. Cronbach's Alpha internal consistency reliability coefficient was found to be 0.92.
    Self-Compassion Scale Short Form (STS-C)
    The scale developed by Neff (2003) was validated and reliable in Turkish by Yıldırım and Sarı in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. Neff (2014) used the scale he developed in parents with children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. SSS-F It is recommended to be used in studies where total score will be used to measure self-compassion.
    Conscious Awareness Scale (CIFS)
    It was developed by Brown and Ryan (2003) in order to evaluate the CP level of individuals. In the study of Ozgreen et al. (2011), its Turkish validity and reliability were performed. The scale is a one-dimensional, six-point Likert-type scale consisting of 15 questions. The Cronbach's alpha coefficient of the scale was found to be 0.80. The minimum and maximum points that individuals can get from the scale are between 15 and 90. High scores indicate a high BF level.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2023
    Last Updated
    January 12, 2023
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05693662
    Brief Title
    The Effect of Mindfulness-Based Self-Compassion Education Given to Parents of Children With Autism Spectrum Disorder
    Official Title
    The Effect of Mindfulness-Based Self-Compassion Education Given to Parents of Children With Autism Spectrum Disorder on Stress, Psychological Resilience and Well-Being
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Autistic Spectrum Disorder (ASD) is an important public health problem in our country as well as all over the world. The physical, psychological, social and economic problems and mood disorders experienced by the parents of these children can negatively affect not only themselves, but also the effectiveness of the intervention and treatment programs applied to the children. Therefore, many mindfulness-based intervention programs aim to improve stress reduction, resilience and well-being in parents. In this study, it is aimed to evaluate the effect of mindfulness-based self-compassion training given to parents of children with ASD on stress, resilience and well-being. The research will be carried out with the parents of children aged 7-12 years who applied to the Child and Adolescent Psychiatry Outpatient Clinic of Atatürk University Health Research and Application Center located in Erzurum city center between December 2022 and October 2024 and diagnosed with ASD. The sample of the study was determined by G-power analysis. With the power analysis, it was calculated that at least 65 parents should be included in the sample, in the calculation made at the level of α=0.05, the effect size of 150, 153 (d=0.8) and the power of the study to be 90%. Therefore, the sample size of this study is planned to be 65. The parents of the children with ASD included in the study will be randomized in a single-blind manner, and experimental and control groups will be formed. After the pre-tests are applied to both groups, Awareness-Based Self-Compassion Training will be given to the experimental group and the effect of this training will be tried to be determined with the final measurements. The purpose of Awareness-Based Self Compassion Training; It is aimed at helping parents of children with ASD to cope with stress, increase their psychological resilience and improve their well-being skills. In the collection of research data, an introductory information form containing the socio-demographic data of the child with ASD and the parent, prepared by the researcher in line with the literature, Parental Stress Scale (SIDS), Psychological Resilience Scale for Adults, Warwick-Edinburgh Mental Well-Being Scale, Self-Compassion Scale Short Form (SSS-F), Conscious Awareness Scale (CIFI) will be used. SPSS 22.0 package program will be used in the evaluation of the data obtained in the research. In the evaluation of data, number, standard deviation, percentile, mean, minimum and maximum values, Kolmogorov-Smirnov, Shapiro-Wilk analysis, histogram and skewness-kurtosis tests, independent groups t-test, chi-square test, paired, Wilcoxon test, Mann- Whitney U test, Spearman's correlation test, Cronbach's alpha will be done. When the international and national literature is examined, no studies have been found on reducing stress, increasing psychological resilience and well-being of Awareness-Based Self-Compassion training. Considering the problems experienced by the parents of children with ASD, it is thought that, as an evidence-based practice of Awareness-Based Self-Compassion training, attempts to be made for parents regarding stress, psychological resilience and well-being are important. As a result of the research, Awareness-Based Self-Compassion Education is expected to reduce stress and increase psychological resilience and well-being in parents of children with ASD.
    Detailed Description
    Autism spectrum disorder (ASD) is a developmental disability that can cause a wide variety of difficulties in social interaction, communication, and behavior. ASD is defined in the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as the presence of limited and repetitive behaviors, interests, or activity patterns with the emergence of permanent impairments in social interaction (American Psychiatric Association, 2013). Autism spectrum disorder (ASD) is a lifelong pervasive neurodevelopmental disorder reported to occur in 1 (approximately 2.3%) of 44 8-year-old children in the United States (Alyami et al., 2022; CDC, 2022; Vasilopoulou). and Nisbet, 2016). Symptoms of ASD vary greatly depending on the child's developmental level and chronological age, and may include a number of behavioral symptoms such as hyperactivity, impulsivity, aggression, self-harming behavior, tantrums, and delayed toilet training (Neff & Faso, 2015; Duarte et al. ., 2005). Supporting children with ASD is often complex, requiring multidisciplinary teamwork and continuity of care (Kohane et al. 2012; Lee et al. 2015). Parents of children with ASD must manage many aspects of caregiving that can be challenging and overwhelming (Bekhet et al., 2012). It has been reported that parents of autistic children experience lower quality of life, more depression, and more pessimism about the future than parents of children with normal development and parents of children with other developmental disabilities (Cappe et al., 2011; Johnson et al., 2011). The number of published studies on the impact of ASD on parents has increased over the past two decades. In a meta-analysis study, it was found that parents of autistic children have higher levels of parenting stress than parents of normally developing children or parents of children with other disabilities (for example, Down syndrome, cerebral palsy, intellectual disability) (Hayes & Watson, 2008). 2013). Severe behavioral symptoms in a child with ASD have been associated with parenting stress, increased depression and anxiety symptoms (Cachia et al., 2016; Junior et al., 2016), and general psychological distress (Keenan et al., 2016). Stigma in social interaction affects well-being and stress in parents caring for a child with ASD (Chan & Lam, 2017; Kinnear et al., 2016; Mak & Kwok, 2010). In addition, it was stated that the well-being of parents was positively affected by social support (Werner & Shulman, 2013). The severity of a child's autism symptoms and behaviors has consistently been found to be one of the strongest predictors of parental stress (Davis & Carter, 2008; Ingersoll & Hambrick, 2011; Lyons et al., 2010; Hall & Graff, 2012). Children with ASD usually develop anger, aggression, self-harm, tantrums, and repetitive behaviors that are described by parents as destructive, unpredictable, and difficult to manage (Ludlow et al. 2011). Since parents cannot "control" their children due to these situations, they are thought to be misbehaving by strangers and may receive condemnation and disapproval. Parents experience shame due to this situation (Mak & Kwok, 2010; Neff & Faso, 2015). In a study, it was determined that parenting stress levels should be considered when designing early education interventions for children with ASD. Helping parents of children with ASD reduce their stress levels enables the child to achieve greater gains in time-intensive early education intervention programs (Osborne et al., 2008). Unless parents successfully cope with important stressors and effectively manage mental health problems, the expected effect of behavioral therapies for their children may be low (Osborne et al., 2008), and behavioral problems may increase in children due to parental stress (Lecavalier et al. et al., 2006 ; McGrath, 2013 ; Neece et al., 2012). Self-compassion, which includes being kind to oneself in difficult times, recognizing the common nature of human suffering, and being consciously aware of negative thoughts and emotions, is cited as one of the factors that can be an important coping strategy. Self-compassion includes being open and sensitive to one's emotions in the face of one's own negative experiences, a willingness to reduce the pain arising from these experiences, and approaching oneself with compassion. Self-compassion has three different components: self-compassion, shared experience of humanity, and conscious awareness (Neff, 2003). The "self-compassion" dimension of self-compassion shows the potential of a person to approach one's negative feelings, thoughts, actions or impulses in a forgiving, empathetic, sensitive and patient manner (Gilbert & Irons, 2005).The "common experience of humanity" dimension of self-compassion requires knowing that being human brings with it limited power and that everyone can have flaws and deficiencies. The third dimension of self-compassion, "conscious awareness", includes being able to pay attention to the very moment one is in, clearly and consciously, being aware of and accepting whatever is happening at that moment. Besides being mindful, it is also very important to be able to pay attention to the present moment with compassionate and friendly attention. Mindfulness includes the ability to name and observe the emotions and thoughts one has at the moment, rather than reacting impulsively. In order for an individual to show self-compassion, he must first be aware of his pain (Neff & Tirch, 2013). Awareness requires acknowledging the reality of experiences rather than escaping painful feelings. Therefore, mindfulness is an inevitable component of self-compassion and helps with emotion regulation. Emotion regulation; Being aware of the emotion, intensity and duration of feeling the emotion in the face of negative life experiences (Thompson, 1994). In other words, conscious awareness; It is to be able to provide balanced control of emotions without allowing the individual to accept his painful feelings, but without allowing these feelings to create anxiety in him (Neff, 2003). In a study conducted with parents of children with ASD, it has been shown that parental stress and well-being are affected by self-compassion (Neff & Faso, 2015; Wong et al., 2016). In a recent study on Mindfulness-Based Stress Reduction (MBSR) and Self-Compassion (SC) training for parents of children with ASD, it was reported that the education applied in parents reduced stress and anxiety and increased their awareness of attention (Rojas-Torres, 2021). In the literature, international studies on Awareness-Based Self-Compassion training on stress reduction in parents of children with ASD are limited (Rojas-Torres, 2021). International studies on increasing resilience and well-being of Mindfulness-Based Self-Compassion training have not been found. When national surveys were examined, no study was found on the use of Mindfulness-Based Self-Compassion training to reduce stress, increase resilience and well-being. Considering the stress situations experienced by the parents of children with ASD, it is thought that the practice of Awareness-Based Self-Compassion training, as an evidence-based practice, is important for parents regarding stress, resilience and well-being.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Awareness, well-being, self-compassion, resilience, stress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient Education Booklet
    Arm Type
    Experimental
    Arm Description
    Before applying to the parents of the children with ASD included in the experimental group, After the pre-test data are collected, 8 sessions of Awareness-Based Self-Compassion training will be given to the parents in the experimental group. The first two sessions will be held face-to-face, and the remaining sessions will continue online. Each session will be planned for 3 days to 7 days for its activity and continuity. One week after the Awareness-Based Self-Compassion training (after 8 sessions were completed), parents were given the "Parental Stress Scale (PASS)", "Adult Resilience Scale", "Warwick-Edinburgh Mental Well-Being Scale", "Self-Compassion Scale". Short Form (SSS-F)", "Conscious Awareness Scale (CIFS)" post-test will be filled face to face.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-Based Self-Compassion Education
    Intervention Description
    An education booklet created within the scope of ASD diagnosis will be presented to the parents of children with ASD. The booklet will be prepared in line with the relevant literature, including the development of the child with ASD, activities of daily living, social communication skills, and the processes of awareness-based self-compassion education in an 8-session interview with parents. The booklet will be presented to the parents participating in the research at the first session of the Mindfulness-Based Self-Compassion Training. During the creation of the training booklet, the final form of the booklet will be given by taking the opinions of the experts and in line with the relevant suggestions.
    Primary Outcome Measure Information:
    Title
    Parental Stress Scale (PASS)
    Description
    It was developed by Özmen and Özmen (2012) to measure the stress experienced by mothers and fathers in their relationships with their children in daily life. ABSQ consists of a single factor structure consisting of 16 items. The Cronbach alpha coefficient of the scale is .85. The scale is a four-point Likert type (Always=4, Often=3, Sometimes=2, Never=1). The lowest score that can be obtained from the scale is 16, and the highest score is 64. A high score from the scale indicates that parental stress is high.
    Time Frame
    up to 24 hours
    Title
    Resilience Scale for Adults
    Description
    The dimensions in the scale are called 'self-perception', 'perception of the future', 'structural style', 'social competence', 'family cohesion' and 'social resources'. In the scale, which includes a total of 33 items, a format is used in which positive and negative features are on different sides, and five separate boxes are used for answers in order to avoid biased evaluations in choosing the items. In the schematic evaluation, the scoring method was released in the high or low measurement of psychological resilience.Cronbach Alpha values calculated for the reliability of the scale; It was calculated as 0.76 for 'Self Perception', 0.75 for 'Future Perception', 0.84 for 'Social Competence', 0.89 for 'Family Cohesion', 0.80 for 'Social Resources' and 0.76 for 'Structural Style.
    Time Frame
    up to 24 hours
    Title
    Warwick-Edinburgh Mental Well-Being Scale
    Description
    Tennant et al. (2007) and adapted into Turkish by Keldal (2015). Consisting of 14 items and a single dimension, this scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a 5-point Likert type, with a scoring of 1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree. A minimum of 14 and a maximum of 70 points are obtained from the scale. High scores obtained from the scale indicate high mental (psychological) well-being. All items of the scale are positive. Cronbach's Alpha internal consistency reliability coefficient was found to be 0.92.
    Time Frame
    up to 24 hours
    Title
    Self-Compassion Scale Short Form (STS-C)
    Description
    The scale developed by Neff (2003) was validated and reliable in Turkish by Yıldırım and Sarı in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. Neff (2014) used the scale he developed in parents with children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. SSS-F It is recommended to be used in studies where total score will be used to measure self-compassion.
    Time Frame
    up to 24 hours
    Title
    Conscious Awareness Scale (CIFS)
    Description
    It was developed by Brown and Ryan (2003) in order to evaluate the CP level of individuals. In the study of Ozgreen et al. (2011), its Turkish validity and reliability were performed. The scale is a one-dimensional, six-point Likert-type scale consisting of 15 questions. The Cronbach's alpha coefficient of the scale was found to be 0.80. The minimum and maximum points that individuals can get from the scale are between 15 and 90. High scores indicate a high BF level.
    Time Frame
    up to 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: To be at least a primary school graduate. Being the parent of a child whose age is 7-12 and diagnosed with ASD. Willingness to participate in the study. To be open to communication and cooperation. Exclusion Criteria: Parental psychiatric problems.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MİNE Cengiz
    Phone
    05308864974
    Email
    mine.cengiz@atauni.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    DİLEK KILIÇ
    Phone
    05052527704
    Email
    dilekk@atauni.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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