ClinicalTrials.gg
Active, not recruitingNCT06527118Updated Jul 30, 2024

The Effect of Self-Care Education on Self-Care Skills and School Sociality

An interventional study of ACTIVITIES TO LEARN SELF CARE SKILLS in Education and Intellectual Disabilities With Other Behavioral Symptoms, sponsored by Dokuz Eylul University. Active, not recruiting at 1 site in Turkey. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study 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.

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).

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).

02

Conditions studied

  • Education
  • Intellectual Disabilities With Other Behavioral Symptoms

Keywords

  • Child with intellectual disabilities
  • self-care
  • socialization
03

In context

Behavioral Symptoms

135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.

This study's planned enrollment of 34 is below the median of 93 across 114 interventional studies indexed under Behavioral Symptoms.

Browse Behavioral Symptoms studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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)

Exclusion criteria

Exclusion Criteria:

  • Physical disability in addition to mental disability
  • Getting sick or having an attack during work
  • Illiteracy of parents
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    The Group to which the Self-Care Skills Learning Activity Program will be implemented

    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.

    Other: ACTIVITIES TO LEARN SELF CARE SKILLS

  • No intervention
    Self-Care Skills Learning Activity Program Not Implemented Group

    No intervention was applied to the control group.

Interventions

  • OtherACTIVITIES TO LEARN SELF CARE SKILLS

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 Weeks

  2. 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.

    Time frame: 12 Weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Sep 2023, 3 months.

Of 68 non-industry interventional studies with no phase under Behavioral Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 3 months is below that.

Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 16 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2024
First posted
Jul 30, 2024
StartActual
May 12, 2023
Primary completionActual
Sep 5, 2023
CompletionEst.
Jul 31, 2024
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06527118
Responsible party
Gulendam Karsadag (Assistant Profesor, Dokuz Eylul University) — Principal investigator
First posted
Jul 30, 2024
Start date
May 12, 2023
Primary completion
Sep 5, 2023
Completion
Jul 31, 2024 (estimated)
Last update
Jul 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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