NCT06527118

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 11, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

Child with intellectual disabilitiesself-caresocialization

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    12 Weeks

Study Arms (2)

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.

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.

Interventions

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.

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

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Physical disability in addition to mental disability
  • Getting sick or having an attack during work
  • Illiteracy of parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: pretest-posttest, follow-up control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profesor

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 30, 2024

Study Start

May 12, 2023

Primary Completion

September 5, 2023

Study Completion

July 31, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations