It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral PalsyNCT06854172
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
An observational study of It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral Palsy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral Palsy
- What is being tested?
- Mindfulness based self-compassion training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 8 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The universe of the study consists of Special Education and Rehabilitation Centers in Siirt province. There are a total of 3000 patients registered in Special Education and Rehabilitation Centers. The number of children with cerebral palsy is 252. The parents of children who meet the inclusion criteria will be included in the sample of the study.
Who may be able to join
- 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.
- Having been diagnosed with Cerebral Palsy,
- Being registered in a special education and rehabilitation center.
Who cannot join
- Caring for other dependents (elderly, disabled, etc.),
- Having a mental illness (major depression, psychosis, etc.),
- Having communication problems,
- Not continuing education.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Special Education and Rehabilitation Centers
Siirt, Siirt, 56100
About this study
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.
- Conditions
- It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral Palsy
- Being tested
- Mindfulness based self-compassion training
- Keywords
- mındfulness, self compassion, education, cerebral palsy, parent, care burden, emotional regulation
- Medical subject headings
- Cerebral Palsy, Caregiver Burden, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based self-compassion trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness based self-compassion training | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A personal information form will be filled out regarding the descriptive information of the parents in the experimental and control groups. (Personal information form)
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.
Measured: Day 1 and up to study completion, average 9 weeks".
A self-efficacy scale will be applied to determine the self-efficacy levels of parents. (Parent self-efficacy scale)
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.
Measured: Day 1 and up to study completion, average 9 weeks
With this scale, the care burden of parents will be evaluated. (Zarit caregiver load scale)
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
Measured: Day 1 and up to study completion, average 9 weeks
In the study, the Cognitive Emotion Regulation Scale will be used to determine parents' emotion regulation. (Cognitive Emotion Regulation Scale)
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:
- Self-blame
- Acceptance
- Focus on thought
- Positive refocusing
- Refocusing on plan
- Positive reconsideration
- Putting into perspective
- Catastrophizing
- Blaming others
Measured: Day 1 and up to study completion, average 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Dec 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion8 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suheyla YURT, Ataturk University
- Investigators
- Suheyla Yurt, PhD Student, Principal investigator, Siirt UniversitySibel ASİ KARAKAŞ, Professor, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854172
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/436
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35023213van 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.
PubMed 39343726Schuling 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.
PubMed 32421612
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06854172
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/436
- Conditions
- It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral Palsy
- Keywords
- mındfulness, self compassion, education, cerebral palsy, parent, care burden, emotional regulation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 8 May 2025 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion training will be given to the experimental group | – | Behavioral: Mindfulness based self-compassion trainingAwareness-based self-compassion training will be provided to parents of children with cerebral palsy. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The universe of the study consists of Special Education and Rehabilitation Centers in Siirt province. There are a total of 3000 patients registered in Special Education and Rehabilitation Centers. The number of children with cerebral palsy is 252. The parents of children who meet the inclusion criteria will be included in the sample of the study.
Key inclusion criteria (6 listed)
- 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.
- Having been diagnosed with Cerebral Palsy,
Key exclusion criteria (4 listed)
- Caring for other dependents (elderly, disabled, etc.),
- Having a mental illness (major depression, psychosis, etc.),
- Having communication problems,
- Not continuing education.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based self-compassion trainingSelf-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. | Behavioural | Self-compassion training will be given to the experimental group |
Primary outcome
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".
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.
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
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.
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
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
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
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: 1. Self-blame 2. Acceptance 3. Focus on thought 4. Positive refocusing 5. Refocusing on plan 6. Positive reconsideration 7. Putting into perspective 8. Catastrophizing 9. Blaming others
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 35023213Prest 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.
- Background: PubMed 39343726van 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.
- Background: PubMed 32421612Schuling 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suheyla Yurt, PhD Student principal investigator
Siirt University
Sibel ASİ KARAKAŞ, Professor study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of It is Planned to Provide Self-compassion Training to Parents of Children With Cerebral Palsy, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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".). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06854172, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.