Cerebral PalsyNCT06245733
Study of the Effect of Compassion-Based Education Program Applied to Mothers of Children Diagnosed With Cerebral Palsy
A study testing Compassion-Based Education Program Adapted for Adults in people with Cerebral Palsy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the study; The aim of this study is to examine the effect of a compassion-based education program applied to mothers of children with cerebral palsy on compassion fatigue, depression, and psychological resilience. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Compassion-Based Education Program Adapted for Adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being the mother of a child with Cerebral Palsy
Who cannot join
- Mothers who have children with Cerebral Palsy do not want to participate in the study and want to leave the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep, Central, 27100
Sezer Avcı, 1, +90-506-856-0446, sezer.avci@hku.edu.tr
About this study
Official title: Investigation of the Effect of Compassion-Based Education Program Applied to the Mothers of Children Diagnosed With Cerebral Palsy on Compassion, Depression and Resilience
Purpose of the study; The aim of this study is to examine the effect of a compassion-based education program applied to mothers of children with cerebral palsy on compassion fatigue, depression, and psychological resilience.
Read the detailed description
The Hypotheses of the Study
Main Hypothesis: "Compassion-Based Education Program Adapted for Adults" in increasing the compassion levels and psychological resilience of mothers of patients with CP; It is effective in reducing the level of depression.
As sub-hypotheses:
H1: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Compassion Scale are significantly higher than the scores they obtained before the application (pre-test).
H2: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Burns Depression Scale-Turkish Form are significantly lower than the scores they obtained before the application (pre-test).
H3: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Resilience Scale are significantly higher than the scores they obtained before the application (pre-test).
- Conditions
- Cerebral Palsy
- Being tested
- Compassion-Based Education Program Adapted for Adults
- Keywords
- Serebral Palsi, Depression, Resilience, Compassion
- Medical subject headings
- Cerebral Palsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Based Education Program Adapted for AdultsOther
Training will be given once a week. This training will last 10 weeks in total.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants who will receive the training Receives: Other: Compassion-Based Education Program Adapted for Adults |
| Control Group | No intervention | participants who will not be interfered with |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and Evaluation of Depression
Burns Depression Scale will be applied to all participants. Depression levels will be determined.
Measured: Day 1
Assessment and Evaluation of Psychological Resilience
Psychological Resilience Scale for Adults will be applied to all participants. Psychological Resilience levels will be determined.
Measured: Day 1
Assessment and Evaluation of Compassion
Compassion Scale will be applied to all participants. Compassion levels will be determined .
Measured: Day 1
Secondary outcomes (3)
The last test of Assessment and Evaluation of Depression
Burns Depression Scale will be applied to all participants. Depression levels will be determined due to showing effectiveness of training.
Measured: through study completion, an average of 1 week.
The last test of Assessment and Evaluation of Psychological Resilience
Psychological Resilience Scale will be applied to all participants. Resilience levels will be determined due to showing effectiveness of training.
Measured: through study completion, an average of 1 week.
The last test of Assessment and Evaluation Compassion
Compassion Scale will be applied to all participants. Compassion levels will be determined due to showing effectiveness of training.
Measured: through study completion, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Sep 2023
- Primary completion14 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat SEVEN, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245733
- Sponsor's protocol ID
- MSEVEN
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Compassion-Based Education Program Applied to the Mothers of Children Diagnosed With Cerebral Palsy on Compassion, Depression and Resilience
- ClinicalTrials.gov ID
- NCT06245733
- Acronym / sponsor ID
- MSEVEN
- Conditions
- Cerebral Palsy
- Keywords
- Serebral Palsi, Depression, Resilience, Compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
Purpose of the study; The aim of this study is to examine the effect of a compassion-based education program applied to mothers of children with cerebral palsy on compassion fatigue, depression, and psychological resilience.
Detailed description
The Hypotheses of the Study
Main Hypothesis: "Compassion-Based Education Program Adapted for Adults" in increasing the compassion levels and psychological resilience of mothers of patients with CP; It is effective in reducing the level of depression.
As sub-hypotheses:
H1: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Compassion Scale are significantly higher than the scores they obtained before the application (pre-test).
H2: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Burns Depression Scale-Turkish Form are significantly lower than the scores they obtained before the application (pre-test).
H3: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Resilience Scale are significantly higher than the scores they obtained before the application (pre-test).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Compassion-Based Education Program Adapted for AdultsParticipants who will receive the training |
| Control Group | No intervention | –participants who will not be interfered with |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Being the mother of a child with Cerebral Palsy
Key exclusion criteria (1 listed)
- Mothers who have children with Cerebral Palsy do not want to participate in the study and want to leave the study.
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 |
|---|---|---|
| Compassion-Based Education Program Adapted for AdultsTraining will be given once a week. This training will last 10 weeks in total. | Other | Experimental Group |
Primary outcome
Assessment and Evaluation of Depression
Time frame: Day 1
Burns Depression Scale will be applied to all participants. Depression levels will be determined.
Assessment and Evaluation of Psychological Resilience
Time frame: Day 1
Psychological Resilience Scale for Adults will be applied to all participants. Psychological Resilience levels will be determined.
Assessment and Evaluation of Compassion
Time frame: Day 1
Compassion Scale will be applied to all participants. Compassion levels will be determined .
3 secondary outcomes
The last test of Assessment and Evaluation of Depression
Time frame: through study completion, an average of 1 week.
The last test of Assessment and Evaluation of Psychological Resilience
Time frame: through study completion, an average of 1 week.
The last test of Assessment and Evaluation Compassion
Time frame: through study completion, an average of 1 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Based Education Program Adapted for Adults in people with Cerebral Palsy, run by Hasan Kalyoncu 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat SEVEN, 1 (+90-501-131-8007, murat.seven@std.hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment and Evaluation of Depression (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.