Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability

Intellectual Disability Clinical Trial

Official title:

Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635969
• Other study ID #: 2020/20
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: August 2022

Study information

• Verified date: June 2022
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Problem
• Intellectual Disability
• Problem Behavior
• Sexuality

Intervention

Behavioral:
• Sexual Health and Development Education for Children With Intellectual Disability
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.

Locations

Country	Name	City	State
Turkey	Zonguldak Special Therapy Special Education and Rehabilitation Center	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Aylin KURT

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Secondary	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.	12 months

External Links

•   Sexual Education and Development in Children with Intellectual Disability: Mothers' Opinions