- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635969
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
By integrating sexuality and disability literatures, theories, and research, this study aims to: determine the effectiveness of sexual health and development education for children (12-18 years) with mild to moderate intellectual disability.
The research hypotheses are as follows:
H0: There is no significant difference between the intervention group and the control group in the mean score of the "Sexual Development Characteristics Scale of Children with Mentally Retardation in Adolescence" after the sexual health and development trainings given to children with intellectual disabilities.
H1: After the sexual health and development trainings given to children with intellectual disabilities, the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" is significantly higher in the intervention group compared to the control group.
Study Overview
Status
Intervention / Treatment
Detailed Description
By integrating sexuality and disability literatures, theories, and research, this study aims to: determine the effectiveness of sexual health and development education for children (12-18 years) with mild to moderate intellectual disability. The number of children in the groups will be analyzed based on another study in which one of the scales to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.8, it was seen that at least 24 cases in each group (total 48 children) would be sufficient for 80% power. These children will be selected from 48 children who got the least score from the "Sexual Development Characteristics of Adolescent Children with Intellectual Disability Scale". In this way, the criteria sampling method will be used. In this way, the criteria sampling method will be used. Anticipated duration is one year.
The inclusion criteria of the children in the study are as follows:
- Being between the ages of 12-18
- Having mild to moderate mental disability
- Parent's agreement to participate in research
- Lack of speech and vision impairment
- Completing all trainings and follow-ups during the research period
For intervention group:
Once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. Participants will be expected to attend 8 training sessions over a two months period, each are up to half hours in length. Follow-up will be made at the beginning of the training, right after the last training and one month after the last training after the questionnaire. Data analysis will begin once all trainings have been completed. Investigators anticipate completing the study, including primary analyses, within one year from the date recruitment begins.
For control group:
Once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. Children in the control group will not be educated.Follow-up will be made at the beginning of the training, right after the last training and one month after the last training after the questionnaire. Data analysis will begin once all trainings have been completed. Investigators anticipate completing the study, including primary analyses, within one year from the date recruitment begins. After the study is completed, training will be provided to children in the control group in a way that will not affect the data of the study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zonguldak, Turkey, 67600
- Recruiting
- Zonguldak Special Therapy Special Education and Rehabilitation Center
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Contact:
- Şüheda Özer
- Phone Number: +90 372 222 13 14
- Email: aylinkurt67@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between the ages of 12-18
- Mild to moderate intellectual disability
- Parents agree to participate in research.
- Lack of speech and vision impairment
- Completing all trainings and follow-ups during the research period
Exclusion Criteria:
- Not being between the ages of 12-18
- Having several intellectual disability
- Parents not agree to participate in research.
- Having speech and vision impairment
- Not completing all trainings and follow-ups during the research period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Children training
All registered participants in intervention group will participate in a series of trainings on sexuality education.
|
Sexual Health and Development Education for Children With Intellectual Disability: It is aimed to eliminate the problems related to personal care and cleaning of children with mental retardation, to learn the symptoms of adolescence and to learn the methods of protection from abuse.
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No Intervention: Control: No intervention
All registered participants in control group will not participate in a series of trainings on sexuality education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the mean scores obtained by the children in the intervention group from the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" before and after the trainings
Time Frame: 12 months
|
"Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" will be completed before trainings that gathers quantitative data that will address attitudes about the children sexual health and development.
The survey will also be completed at the end of trainings and one month after the final training.
The quantitative data will be used to measure a change in the children's attitudes, and behaviors before and after the proposed intervention.
Data will be analyzed using Statistical Package for the Social Sciences package program.
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12 months
|
Difference between the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" between intervention and control groups
Time Frame: 12 months
|
"Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" will be completed before trainings that gathers quantitative data that will address attitudes about the children sexual health and development.
The survey will also be completed at the end of trainings and one month after the final training.
The quantitative data will be used to measure a change in the children's attitudes, and behaviors before and after the proposed intervention.
Measurements will be made without training the control group.
At the end of the study, Difference between the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" between intervention and control groups will be examined.
Data will be analyzed using Statistical Package for the Social Sciences package program.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children achieve 70% success in questions about education after each training
Time Frame: 12 months
|
In order for children to move on to the next training, they must obtain 70% success points from post-training questions.
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12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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