EducationNCT06527118
The Effect of Self-Care Education on Self-Care Skills and School Sociality
A study testing ACTIVITIES TO LEARN SELF CARE SKILLS in people with Education and Intellectual Disabilities With Other Behavioral Symptoms, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of self-care education given to children with educable intellectual disabilities on children\'s self-care skills and school social behaviors. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Education, Intellectual Disabilities With Other Behavioral Symptoms
- What is being tested?
- ACTIVITIES TO LEARN SELF CARE SKILLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 31 Jul 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child has mild and moderate intellectual disability (Determined by the health reports available at the institution. Children with mild and moderate intellectual disability were included in the study).
- Between the ages of 6 and 10
- Volunteering to participate in the study and signing the informed consent form by the child's parent
- Following verbal instructions (determined by the reports given as a result of the evaluation conducted by the Guidance and Research Center)
Who cannot join
- Physical disability in addition to mental disability
- Getting sick or having an attack during work
- Illiteracy of parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Care Education Given to Children With Educable Mental Disabilities on Children's Self-Care Skills and School Social Behaviors
The aim of this study is to examine the effect of self-care education given to children with educable intellectual disabilities on children\'s self-care skills and school social behaviors.
H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \"Eating Skills\" subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
Read more
H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \"Dressing Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \"Personal Care Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \"Social Competence\" sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
Read the detailed description
H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \"Eating Skills\" subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \"Dressing Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \"Personal Care Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \"Social Competence\" sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
- Being tested
- ACTIVITIES TO LEARN SELF CARE SKILLS
- Keywords
- Child with intellectual disabilities, self-care, socialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVITIES TO LEARN SELF CARE SKILLSOther
This activity program, which was prepared to develop self-care skills, aims to teach self-care skills of children with intellectual disabilities by having fun. The program was prepared by the educator and finalized after the approval of expert opinions.
| Study group | Role | What they receive |
|---|---|---|
| The Group to which the Self-Care Skills Learning Activity Program will be implemented | Active comparator | The "Activity Program for Learning Self-Care Skills", which was prepared by the educator after receiving expert opinions, was applied individually to each child in the intervention group for 12 weeks. The training was 1 day a week for 40 minutes. Receives: Other: ACTIVITIES TO LEARN SELF CARE SKILLS |
| Self-Care Skills Learning Activity Program Not Implemented Group | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care Skills Checklist Scale
"Self-Care Skills Checklist Scale" developed by Konya (2007) was used to measure children's self-care skills. The Checklist consists of 3 sections. These are Eating Skills (14 items), Dressing Skills (19 items) and Personal Care Skills (9 items). In order to determine the level of development of the skills in the checklist, "Very Adequate (5 points), Adequate (4 points), Somewhat Adequate (3 points), Inadequate (2 points), Very Inadequate (1 point)" options were used. The minimum score that can be obtained from the scale is 42 and the maximum score is 210. A high score indicates high self-care skills.
Measured: 12 Weeks
School Social Behavior Scale
It was developed by Kenneth W. Merrell in 1993 in the United States of America as a scale that can be used by classroom teachers or other teachers in K-12 schools (from preschool to high school) to assess individual students. Cognitive-behavioral theory was used in the development of the items. The scale consists of two forms: Form A: Social Competence Form B: Negative Social Behavior Only the Social Competence Form was used in our study. In the final factor analysis of the Social Competence sub-dimension, three factors were identified: Interpersonal Relationships, Self-Control Skills and Academic Skills. The minimum score that can be obtained from the Social Competence form is 32 and the maximum score is 160. A high score indicates that the individual has high social skills.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start12 May 2023
- Primary completion5 Sep 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pretest-posttest, follow-up control group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulendam Karsadag, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527118
- Sponsor's protocol ID
- DokuzEU-HSH-GK-01
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 30 Jul 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Care Education Given to Children With Educable Mental Disabilities on Children's Self-Care Skills and School Social Behaviors
- ClinicalTrials.gov ID
- NCT06527118
- Acronym / sponsor ID
- DokuzEU-HSH-GK-01
- Keywords
- Child with intellectual disabilities, self-care, socialization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 30 Jul 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.
The aim of this study is to examine the effect of self-care education given to children with educable intellectual disabilities on children\'s self-care skills and school social behaviors.
H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \"Eating Skills\" subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \"Dressing Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \"Personal Care Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \"Social Competence\" sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
Detailed description
H1a: There is a difference between the mean scores of the children in the experimental and control groups in the \"Eating Skills\" subscale of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1b: There is a difference between the mean scores of the children in the experimental and control groups on the \"Dressing Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1c: There is a difference between the mean scores of the children in the experimental and control groups on the \"Personal Care Skills\" sub-dimension of the Self-Care Skills Checklist according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
H1d: There is a difference between the mean scores of the children in the experimental and control groups on the \"Social Competence\" sub-dimension of the School Social Behavior Assessment Scale according to time (pretest, posttest, 1st follow-up, 2nd follow-up).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pretest-posttest, follow-up control group
| Arm | Type | Receives |
|---|---|---|
| The Group to which the Self-Care Skills Learning Activity Program will be implemented | Active comparator | Other: ACTIVITIES TO LEARN SELF CARE SKILLSThe "Activity Program for Learning Self-Care Skills", which was prepared by the educator after receiving expert opinions, was applied individually to each child in the intervention group for 12 weeks. The training was 1 day a week for 40 minutes. |
| Self-Care Skills Learning Activity Program Not Implemented Group | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child has mild and moderate intellectual disability (Determined by the health reports available at the institution. Children with mild and moderate intellectual disability were included in the study).
- Between the ages of 6 and 10
- Volunteering to participate in the study and signing the informed consent form by the child's parent
- Following verbal instructions (determined by the reports given as a result of the evaluation conducted by the Guidance and Research Center)
Key exclusion criteria (3 listed)
- Physical disability in addition to mental disability
- Getting sick or having an attack during work
- Illiteracy of parents
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 |
|---|---|---|
| ACTIVITIES TO LEARN SELF CARE SKILLSThis activity program, which was prepared to develop self-care skills, aims to teach self-care skills of children with intellectual disabilities by having fun. The program was prepared by the educator and finalized after the approval of expert opinions. | Other | The Group to which the Self-Care Skills Learning Activity Program will be implemented |
Primary outcome
Self-care Skills Checklist Scale
Time frame: 12 Weeks
"Self-Care Skills Checklist Scale" developed by Konya (2007) was used to measure children's self-care skills. The Checklist consists of 3 sections. These are Eating Skills (14 items), Dressing Skills (19 items) and Personal Care Skills (9 items). In order to determine the level of development of the skills in the checklist, "Very Adequate (5 points), Adequate (4 points), Somewhat Adequate (3 points), Inadequate (2 points), Very Inadequate (1 point)" options were used. The minimum score that can be obtained from the scale is 42 and the maximum score is 210. A high score indicates high self-care skills.
School Social Behavior Scale
Time frame: 12 Weeks
It was developed by Kenneth W. Merrell in 1993 in the United States of America as a scale that can be used by classroom teachers or other teachers in K-12 schools (from preschool to high school) to assess individual students. Cognitive-behavioral theory was used in the development of the items. The scale consists of two forms: Form A: Social Competence Form B: Negative Social Behavior Only the Social Competence Form was used in our study. In the final factor analysis of the Social Competence sub-dimension, three factors were identified: Interpersonal Relationships, Self-Control Skills and Academic Skills. The minimum score that can be obtained from the Social Competence form is 32 and the maximum score is 160. A high score indicates that the individual has high social skills.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
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 ACTIVITIES TO LEARN SELF CARE SKILLS in people with Education and Intellectual Disabilities With Other Behavioral Symptoms, run by Dokuz Eylul 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 3 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 30 Jul 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?
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?
Self-care Skills Checklist Scale (time frame: 12 Weeks). The study lists 2 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 30 Jul 2024.