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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06535100
Study groupRoleWhat they receive
trial (initiative will be implemented)ExperimentalArt therapy artistic therapy, wood painting, lithography, jewelry design, mud free shaping, expression workshop and training workshops
Receives: Behavioral: Art therapy
controlNo interventionstandart care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted2 Aug 2024
  2. Study start3 Jun 2024
  3. Primary completion17 Oct 2024 (estimated)
  4. Study completion17 Nov 2024 (estimated)

Resources

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)
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

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.

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