Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
Primary Purpose
Child Behavior Problem, Intellectual Disability, Sexuality
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sexual Health and Development Education for Children With Intellectual Disability
Sponsored by
About this trial
This is an interventional health services research trial for Child Behavior Problem
Eligibility Criteria
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
Sites / Locations
- Zonguldak Special Therapy Special Education and Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Children training
Control: No intervention
Arm Description
All registered participants in intervention group will participate in a series of trainings on sexuality education.
All registered participants in control group will not participate in a series of trainings on sexuality education.
Outcomes
Primary Outcome Measures
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
"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.
Difference between the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" between intervention and control groups
"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.
Secondary Outcome Measures
Children achieve 70% success in questions about education after each training
In order for children to move on to the next training, they must obtain 70% success points from post-training questions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04635969
Brief Title
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
Official Title
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aylin KURT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Problem, Intellectual Disability, Sexuality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Children training
Arm Type
Experimental
Arm Description
All registered participants in intervention group will participate in a series of trainings on sexuality education.
Arm Title
Control: No intervention
Arm Type
No Intervention
Arm Description
All registered participants in control group will not participate in a series of trainings on sexuality education.
Intervention Type
Behavioral
Intervention Name(s)
Sexual Health and Development Education for Children With Intellectual Disability
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
"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.
Time Frame
12 months
Title
Difference between the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" between intervention and control groups
Description
"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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Children achieve 70% success in questions about education after each training
Description
In order for children to move on to the next training, they must obtain 70% success points from post-training questions.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Zonguldak Special Therapy Special Education and Rehabilitation Center
City
Zonguldak
ZIP/Postal Code
67600
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Şüheda Özer
Phone
+90 372 222 13 14
Email
aylinkurt67@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months
Links:
URL
http://link.springer.com/article/10.1007/s11195-020-09638-z
Description
Sexual Education and Development in Children with Intellectual Disability: Mothers' Opinions
Learn more about this trial
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
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