Child Behavior ProblemNCT06535100
Strong Mother Strong Special Individual
A study testing Art therapy in people with Child Behavior Problem, run by Kastamonu University at 2 sites in Turkey (Türkiye).
Trial summary
Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem
- What is being tested?
- Art therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jun 2024to 17 Nov 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: The population of the study will be mothers who have children diagnosed with moderate and severe mental disabilities in Kastamonu Central district. The sample will be made with 30 mothers to be selected in accordance with the criteria.
Exclusion Criteria:Not volunteering to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Kastamonu University
Kastamonu, Kastamonu, 37300
Havva Kaçan, Dr., 05057753893 ext. 0366 280 41 33, hkacan@kastamonu.edu.tr
- Recruiting
Kastamonu Üniversity
Kastamonu, Kastamonu, 37300
Havva Kaçan, Dr
About this study
Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.
Read the detailed description
Type of Study: The study was planned as a quasi-experimental study according to the pre-test-post-test model. Within the scope of the project, data collection tools for evaluating the effectiveness will be artistic activities, psychodrama, psychological well-being enhancement practices and trainings, and pre-application will be carried out before the training and pre-test data will be obtained. The activities will be completed in a total of 12 weeks. At the end of the project, the scales will be re-applied and post-test data will be obtained. Universe and Sample: The universe of the study will consist of mothers with children diagnosed with moderate and severe mental retardation in the central district of Kastamonu. The sample will be made with 30 mothers who will be selected in accordance with the criteria (Criteria are explained in the method). Evaluation of Data: The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Kolmogorov Smirnov Test will be used to determine whether the research data is normally distributed. According to the Kolmogorov Smirnov Test, if p>0.05, the distribution is determined to be normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are examined. If the Skewness and Kurtosis values are between +2 and -2, the variable is accepted to be normally distributed. Changes in measurements within the group will be analyzed with repeated measures Anova test if the data are normally distributed, and with the Friedman test if the data are not normally distributed.
Data Collection Tool: A questionnaire form consisting of five sections will be used in the study.
Distribution of descriptive characteristics of caregivers: It consists of descriptive questions such as age, gender, education status, economic status, difficulties encountered in child care, and methods used in coping with caregiving.
Psychological well-being scales (PİOÖ) are a scale developed by Ryff (1989) that aims to measure psychological well-being. Psychological Well-being Scales Short Form (PİOÖ-42) was developed by Akın et al. (2012) conducted a validity and reliability study. The PBIÖ is a short form of 42 questions. The PBIÖ is a self-report scale developed by Ryff (1989) that aims to measure psychological well-being. It consists of 6 sub-dimensions (self-acceptance, positive relationships, autonomy, environmental mastery, life purpose and personal development) with 14 questions each, and a total of 84 questions. The scale is scored with a 7-point Likert-type scale, and the highest score that can be obtained is 504 and the lowest score is 84. High scores indicate high psychological well-being. Permission has been obtained for the use of the scale.
*Caregiver Burden Scale (CBBS): The Caregiver Burden Scale is a data collection tool developed by Zarit, Reever and Bach-Peterson (1980) to assess the difficulties experienced by caregivers and to reveal this situation. The adaptation of the scale to Turkish was conducted by İnci. The Caregiver Burden Scale consists of 22 items applied without a time limit. The scale has a Likert-type evaluation ranging from 0 to 4 as "never", "rarely", "sometimes", "often" and "almost always". The minimum score from 0 to 88 points can be obtained from the scale, and a high score means high distress. The version of the scale adapted to Turkish consists of a single dimension, and the internal consistency coefficient of the scale was found to be 0.95. Permission for use of the scale was obtained by İnci. *Emotion Expression Scale: The Emotion Expression Scale was developed by King and Emmons in 1990. The purpose of this scale is to measure some general emotional expressions. The scale, which is based on Likert-type grading, consists of 15 items. The content of the items is related to the tendency of positive, negative, and close emotions. The scale items provide information about the emotional expressions of the individual in interpersonal relationships as well as independently of interpersonal relationships. Focusing on expressive behaviors, the scale was prepared by taking into account both positive and negative emotions. Each item is scored between 1 and 7. 1: indicates that the person strongly disagrees, while 7: indicates that they strongly agree. High scores obtained from the scale indicate that their tendency to express emotions is also high. Permission has been obtained for the use of the scale. *Stress Coping Styles Scale: The Stress Coping Styles Scale (SCTQ) was developed in 1980 by Folkman and Lazarus under the name of "Coping Ways Inventory" as a 68-item, 4-point Likert-type scale. The scale was adapted to Turkish by Şahin and his colleagues in 1992. The shortened form for university students, the Stress Coping Styles Scale (SCTQ), was shortened and re-created by Şahin and Durak in 1995. When the scale was reduced to 30 items and shortened to its final form, it was divided into the following categories: self-confident approach, helpless approach, submissive approach, optimistic approach, and social support seeking approach.
- Conditions
- Child Behavior Problem
- Being tested
- Art therapy
- Keywords
- Child Behavior Problem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapyBehavioural
artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops
| Study group | Role | What they receive |
|---|---|---|
| trial (initiative will be implemented) | Experimental | Art therapy artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops Receives: Behavioral: Art therapy |
| control | No intervention | standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
increasing mental well-being
enabling mothers to take a positive path in communication
Measured: seven weeks apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start3 Jun 2024
- Primary completion17 Oct 2024 (estimated)
- Study completion17 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Behavior ProblemStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Havva Kaçan, Kastamonu University
- Investigators
- Havva Kaçan, Dr, Principal investigator, hkacan@kastamonu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535100
- Sponsor's protocol ID
- Kastamonu
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results will be published when they become available
Publications
Kacan H, Gumus F, Eren N. The Effect of an Art Practice-Based Psycho-Training Program on Psychological Well-Being, Care Burden, Expression of Emotions, and Coping Levels of Mothers Who Have Children With Special Needs. Nurs Open. 2026 Apr;13(4):e70534. doi: 10.1002/nop2.70534.
PubMed 41992455
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Mother Strong Special Individual
- ClinicalTrials.gov ID
- NCT06535100
- Acronym / sponsor ID
- Kastamonu
- Conditions
- Child Behavior Problem
- Keywords
- Child Behavior Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 17 Oct 2024 (estimated)
- Study completion
- 17 Nov 2024 (estimated)
- First posted
- 2 Aug 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.
Special needs individuals with mental disabilities and other special conditions accompanying mental needs (hearing disability, visual disability, physical disability, autism spectrum disorder, multiple disabilities, language and speech disorder, learning disability and emotional/behavioral disorder) are diagnosed with special needs individuals. It includes mothers who are in service. Caregivers of children with mental special needs may experience mental problems such as anxiety, hopelessness and depression, which negatively affects the caregiver's mental resilience and increases their care burden. In order to reduce the care burden, artistic activities will be organized to express the emotions of caregivers.
Detailed description
Type of Study: The study was planned as a quasi-experimental study according to the pre-test-post-test model. Within the scope of the project, data collection tools for evaluating the effectiveness will be artistic activities, psychodrama, psychological well-being enhancement practices and trainings, and pre-application will be carried out before the training and pre-test data will be obtained. The activities will be completed in a total of 12 weeks. At the end of the project, the scales will be re-applied and post-test data will be obtained. Universe and Sample: The universe of the study will consist of mothers with children diagnosed with moderate and severe mental retardation in the central district of Kastamonu. The sample will be made with 30 mothers who will be selected in accordance with the criteria (Criteria are explained in the method). Evaluation of Data: The data obtained in the study will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Kolmogorov Smirnov Test will be used to determine whether the research data is normally distributed. According to the Kolmogorov Smirnov Test, if p>0.05, the distribution is determined to be normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are examined. If the Skewness and Kurtosis values are between +2 and -2, the variable is accepted to be normally distributed. Changes in measurements within the group will be analyzed with repeated measures Anova test if the data are normally distributed, and with the Friedman test if the data are not normally distributed.
Data Collection Tool: A questionnaire form consisting of five sections will be used in the study.
Distribution of descriptive characteristics of caregivers: It consists of descriptive questions such as age, gender, education status, economic status, difficulties encountered in child care, and methods used in coping with caregiving.
Psychological well-being scales (PİOÖ) are a scale developed by Ryff (1989) that aims to measure psychological well-being. Psychological Well-being Scales Short Form (PİOÖ-42) was developed by Akın et al. (2012) conducted a validity and reliability study. The PBIÖ is a short form of 42 questions. The PBIÖ is a self-report scale developed by Ryff (1989) that aims to measure psychological well-being. It consists of 6 sub-dimensions (self-acceptance, positive relationships, autonomy, environmental mastery, life purpose and personal development) with 14 questions each, and a total of 84 questions. The scale is scored with a 7-point Likert-type scale, and the highest score that can be obtained is 504 and the lowest score is 84. High scores indicate high psychological well-being. Permission has been obtained for the use of the scale.
*Caregiver Burden Scale (CBBS): The Caregiver Burden Scale is a data collection tool developed by Zarit, Reever and Bach-Peterson (1980) to assess the difficulties experienced by caregivers and to reveal this situation. The adaptation of the scale to Turkish was conducted by İnci. The Caregiver Burden Scale consists of 22 items applied without a time limit. The scale has a Likert-type evaluation ranging from 0 to 4 as "never", "rarely", "sometimes", "often" and "almost always". The minimum score from 0 to 88 points can be obtained from the scale, and a high score means high distress. The version of the scale adapted to Turkish consists of a single dimension, and the internal consistency coefficient of the scale was found to be 0.95. Permission for use of the scale was obtained by İnci. *Emotion Expression Scale: The Emotion Expression Scale was developed by King and Emmons in 1990. The purpose of this scale is to measure some general emotional expressions. The scale, which is based on Likert-type grading, consists of 15 items. The content of the items is related to the tendency of positive, negative, and close emotions. The scale items provide information about the emotional expressions of the individual in interpersonal relationships as well as independently of interpersonal relationships. Focusing on expressive behaviors, the scale was prepared by taking into account both positive and negative emotions. Each item is scored between 1 and 7. 1: indicates that the person strongly disagrees, while 7: indicates that they strongly agree. High scores obtained from the scale indicate that their tendency to express emotions is also high. Permission has been obtained for the use of the scale. *Stress Coping Styles Scale: The Stress Coping Styles Scale (SCTQ) was developed in 1980 by Folkman and Lazarus under the name of "Coping Ways Inventory" as a 68-item, 4-point Likert-type scale. The scale was adapted to Turkish by Şahin and his colleagues in 1992. The shortened form for university students, the Stress Coping Styles Scale (SCTQ), was shortened and re-created by Şahin and Durak in 1995. When the scale was reduced to 30 items and shortened to its final form, it was divided into the following categories: self-confident approach, helpless approach, submissive approach, optimistic approach, and social support seeking approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial (initiative will be implemented) | Experimental | Behavioral: Art therapyArt therapy artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops |
| control | No intervention | –standart care |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Art therapyartistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops | Behavioural | trial (initiative will be implemented) |
Primary outcome
increasing mental well-being
Time frame: seven weeks apply
enabling mothers to take a positive path in communication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41992455Kacan H, Gumus F, Eren N. The Effect of an Art Practice-Based Psycho-Training Program on Psychological Well-Being, Care Burden, Expression of Emotions, and Coping Levels of Mothers Who Have Children With Special Needs. Nurs Open. 2026 Apr;13(4):e70534. doi: 10.1002/nop2.70534.
- Individual participant dataSharing planned: Undecided. Results will be published when they become available
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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.
Havva Kaçan, Dr principal investigator
hkacan@kastamonu.edu.tr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy in people with Child Behavior Problem, run by Kastamonu University at 2 sites 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?
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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Havva Kaçan, Dr (05057753893 ext. 0366 280 41 33, hkacan@kastamonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increasing mental well-being (time frame: seven weeks apply). 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 NCT06535100, which also lists 1 linked publication.
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 15 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.