- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06854172
Investigating the Effects of Mindfulness-Based Self-Compassion Training Given to Parents of Children with Cerebral Palsy on Parents' Self-Efficacy, Caregiver Burden, and Emotion Regulation
The purpose of this observational study is to learn the effects of Mindfulness-Based Self-Compassion Training given to parents of children with Cerebral Palsy. The main question it aims to answer is:
-Is Mindfulness-Based Self-Compassion Training effective on parents' caregiver burden, self-efficacy, and emotion regulation? Parents who receive self-compassion training will answer survey questions before and after the training.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Siirt, Turkey, 56100
- Special Education and Rehabilitation Centers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria(For parents):
- Having a child diagnosed with cerebral palsy between the ages of 1-18,
- Being literate,
- Not having communication problems,
- Being between the ages of 18-65.
Inclusion Criteria(For childs):
- Having been diagnosed with Cerebral Palsy,
- Being registered in a special education and rehabilitation center.
Exclusion Criteria:
- Caring for other dependents (elderly, disabled, etc.),
- Having a mental illness (major depression, psychosis, etc.),
- Having communication problems,
- Not continuing education.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Self-compassion training will be given to the experimental group
Awareness-based self-compassion training will be provided to parents of children with cerebral palsy.
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Self-compassion training is a program that aims to help individuals develop a kind, understanding and tolerant approach towards themselves.
In this training, individuals learn to be more compassionate towards themselves and to share.
This training can help manage negative emotional states such as stress, anxiety and stress and can lead to a healthier internal balance.
When combined with mindfulness techniques, self-compassion training allows individuals to accept the moment and develop a more compassionate approach towards themselves.
It is thought that this training will be applied to the experimental group to develop parents' feelings of self-compassion and positively affect the parameters of caregiver burden, self-efficacy and emotion regulation designed in the study.
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The control group will not receive self-compassion training
A control group of parents of children with cerebral palsy who were not given mindfulness-based self-compassion training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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A personal information form will be filled out regarding the descriptive information of the parents in the experimental and control groups. (Personal information form)
Time Frame: Day 1 and up to study completion, average 9 weeks".
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The diagnostic form to be used in collecting research data was created by the researcher in line with the relevant literature.
The Personal Information Form includes questions to determine the socio-demographic status of the parents.
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Day 1 and up to study completion, average 9 weeks".
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A self-efficacy scale will be applied to determine the self-efficacy levels of parents. (Parent self-efficacy scale)
Time Frame: Day 1 and up to study completion, average 9 weeks
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This scale, developed by Guimond et al. and adapted to Turkish by Diken, is an assessment tool for measuring mothers' and fathers' perceptions of self-efficacy in parenting.
The scale consists of 17 items in total and is based on a seven-point Likert-type rating system.
Parents respond to statements indicating their perceptions of self-efficacy by marking the appropriate option from the following: (1) "Strongly Disagree", (2) "Disagree", (3) "Partially Disagree", (4) "Undecided", (5) "Partially Agree", (6) "Agree", (7) "Strongly Agree".
The lowest and highest scores that can be obtained from this scale are 17 and 119, respectively.
As the score increases, the positive increase in parents' perceptions of self-efficacy becomes more apparent.
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Day 1 and up to study completion, average 9 weeks
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With this scale, the care burden of parents will be evaluated. (Zarit caregiver load scale)
Time Frame: Day 1 and up to study completion, average 9 weeks
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The Zarit Caregiver Burden Scale was initially developed in 1980 to assess the difficulties faced by caregivers of patients with dementia. Later, the scale was also used to evaluate the challenges faced by caregivers of individuals with schizophrenia. The Turkish version of the scale was translated by Özlü and colleagues, and a validity and reliability study was conducted with the relatives of patients with schizophrenia. The Turkish version consists of 19 items and is structured around five sub-dimensions: psychological distress, disruption of personal life, irritability and restriction, social relationship deterioration, financial burden, and dependency. These sub-dimensions help to assess the various difficulties experienced by caregivers in more detail. The scale is rated on a Likert-type scale with responses ranging from "never," "rarely," "sometimes," "often," to "almost always," with scores ranging from 1 to 5. The Zarit Caregiver Burden Scale is very useful in determining th |
Day 1 and up to study completion, average 9 weeks
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In the study, the Cognitive Emotion Regulation Scale will be used to determine parents' emotion regulation. (Cognitive Emotion Regulation Scale)
Time Frame: Day 1 and up to study completion, average 9 weeks
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This scale was developed to measure the emotion regulation skills of adults. A statistically significant relationship (r=-572) was obtained between the Cognitive Emotion Regulation Scale and the Negative Emotion Scale. Cronbach Alpha, item-total, item-remaining, item discrimination and test-retest methods were used within the scope of reliability studies. It was observed that the item-total correlation values of the scale varied between '.188' and '.468', and the item-remaining correlation values varied between '.104' and '.392'. As a result of the item discrimination analysis, it was concluded that each item had a high discrimination feature. The scale has nine sub-dimensions. These are:
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Day 1 and up to study completion, average 9 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suheyla Yurt, PhD Student, Siirt University
- Study Director: Sibel ASİ KARAKAŞ, Professor, Atatürk University
Publications and helpful links
General Publications
- Prest KR, Borek AJ, Boylan AR. Play-based groups for children with cerebral palsy and their parents: A qualitative interview study about the impact on mothers' well-being. Child Care Health Dev. 2022 Jul;48(4):578-587. doi: 10.1111/cch.12962. Epub 2022 Feb 1.
- van der Kemp J, Ketelaar M, Rentinck ICM, Sommers-Spijkerman MPJ, Benders MJNL, Gorter JW. Exploring Parents' Experiences and Needs During Disclosure of a Cerebral Palsy Diagnosis of Their Young Child: A Scoping Review. Child Care Health Dev. 2024 Nov;50(6):e13327. doi: 10.1111/cch.13327.
- Schuling R, Huijbers MJ, van Ravesteijn H, Donders R, Cillessen L, Kuyken W, Speckens AEM. Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up. J Affect Disord. 2020 Aug 1;273:265-273. doi: 10.1016/j.jad.2020.03.182. Epub 2020 May 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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