Play and PlaythingsNCT05757115
Evaluation and Development of Playing Skills for Parents With Children With Special Needs
A study testing Play Skills Training in people with Play and Playthings, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Children with special needs; experiences physical, behavioral, social, cognitive and emotional limitations. These limitations affect the child's play skills. They need to be supported and encouraged by their parents to enable them to participate in the game. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Play and Playthings
- What is being tested?
- Play Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 31 Aug 2023
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a mother of a special needs child
- The age of her child is 2-6 years
- Being able to speak Turkish
- Volunteer to participate in the study
Who cannot join
- Have training in play therapy
- Having a psychiatric or neurological disease that significantly affects cognitive status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, İ̇stanbul, 34762
About this study
Children with special needs; experiences physical, behavioral, social, cognitive and emotional limitations. These limitations affect the child's play skills. They need to be supported and encouraged by their parents to enable them to participate in the game. Parental playing skills creativity, self-efficacy and active participation are important factors in this regard.
In current studies, parents with special needs children; It is supported that there is a relationship between play, acting and parental self-efficacy. In this study, it was aimed to improve the skills of parents with special needs children to play games with their children multidimensionally and to develop these skills with individual-specific techniques.
Read more
Detailed assessments will be carried out in order to determine the functional, cognitive and psychosocial skills of the parents.
After the evaluation phase is completed, the scores of each parent will be analyzed and interpreted according to Occupational Therapy Models. Playing training will be given individually according to parameters such as strong and weak features, strong sensory system, personality traits, predisposition and defensive approaches.
- Conditions
- Play and Playthings
- Being tested
- Play Skills Training
- Keywords
- Neurodevelopmental Disorders, Autism Spectrum Disorders, Parents, Mentoring, Play and Playthings
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play Skills TrainingBehavioural
Each parent will be provided with "play skills training" that will support them to spend effective and meaningful time with their child. While planning the educational contents, an Occupational Therapy Model suitable for the parent and the child will be used. The process will be followed by giving unique recommendations to each parent. Recommendations given based on feedback will be revised.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | It is the group to which individualized training will be applied to develop play skills. Receives: Behavioral: Play Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Playfulness Trait Scale
The scale consists of 19 items. Each item falls under one of the three subscales: funseeking motivation, uninhibitedness and spontaneity. All items were randomly ordered and used seven-point likert scales with all points labeled (1= "strongly disagree", 7= "strongly agree").
Measured: 2 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start15 Jun 2023
- Primary completion15 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Play and PlaythingsStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Parents with children with special needs who want to participate in the study will be determined. The assessments will be applied to parents before and after play training. These trainings aim to develop the skills of playing games with their children.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Çorakcı Yazıcıoğlu, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757115
- Sponsor's protocol ID
- CORAKCİ-002
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is aimed to share all the collected individual participant data in a scientific publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Development of Playing Skills for Parents With Children With Special Needs
- ClinicalTrials.gov ID
- NCT05757115
- Acronym / sponsor ID
- CORAKCİ-002
- Conditions
- Play and Playthings
- Keywords
- Neurodevelopmental Disorders, Autism Spectrum Disorders, Parents, Mentoring, Play and Playthings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 7 Mar 2023 (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.
Children with special needs; experiences physical, behavioral, social, cognitive and emotional limitations. These limitations affect the child's play skills. They need to be supported and encouraged by their parents to enable them to participate in the game. Parental playing skills creativity, self-efficacy and active participation are important factors in this regard.
In current studies, parents with special needs children; It is supported that there is a relationship between play, acting and parental self-efficacy. In this study, it was aimed to improve the skills of parents with special needs children to play games with their children multidimensionally and to develop these skills with individual-specific techniques.
Detailed assessments will be carried out in order to determine the functional, cognitive and psychosocial skills of the parents.
After the evaluation phase is completed, the scores of each parent will be analyzed and interpreted according to Occupational Therapy Models. Playing training will be given individually according to parameters such as strong and weak features, strong sensory system, personality traits, predisposition and defensive approaches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parents with children with special needs who want to participate in the study will be determined. The assessments will be applied to parents before and after play training. These trainings aim to develop the skills of playing games with their children.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Play Skills TrainingIt is the group to which individualized training will be applied to develop play skills. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a mother of a special needs child
- The age of her child is 2-6 years
- Being able to speak Turkish
- Volunteer to participate in the study
Key exclusion criteria (2 listed)
- Have training in play therapy
- Having a psychiatric or neurological disease that significantly affects cognitive status
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 |
|---|---|---|
| Play Skills TrainingEach parent will be provided with "play skills training" that will support them to spend effective and meaningful time with their child. While planning the educational contents, an Occupational Therapy Model suitable for the parent and the child will be used. The process will be followed by giving unique recommendations to each parent. Recommendations given based on feedback will be revised. | Behavioural | Intervention Group |
Primary outcome
Adult Playfulness Trait Scale
Time frame: 2 mounths
The scale consists of 19 items. Each item falls under one of the three subscales: funseeking motivation, uninhibitedness and spontaneity. All items were randomly ordered and used seven-point likert scales with all points labeled (1= "strongly disagree", 7= "strongly agree").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Yes. It is aimed to share all the collected individual participant data in a scientific publication.
Related trials for Play and Playthings
Recruiting
Technology in Play for Children With Physical Disabilities: the Dice Model of Play
Disability Physical, Disabilities Mental
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play Skills Training in people with Play and Playthings, run by Bezmialem Vakif 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 6 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adult Playfulness Trait Scale (time frame: 2 mounths). 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 6 Sep 2023.