Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-05-22 @ 1:55 AM
Study NCT ID:
NCT04635969
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2020-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
Sponsor:
Aylin KURT
Organization:
Study Overview
Official Title:
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: