ClinicalTrials.Veeva

Menu

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

A

Aylin KURT

Status

Enrolling

Conditions

Sexuality
Child Behavior Problem
Intellectual Disability

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04635969
2020/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Experimental: Children training
Experimental group
Description:
All registered participants in intervention group will participate in a series of trainings on sexuality education.
Treatment:
Behavioral: Sexual Health and Development Education for Children With Intellectual Disability
Control: No intervention
No Intervention group
Description:
All registered participants in control group will not participate in a series of trainings on sexuality education.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems