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

NCT ID: NCT04635969

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Child Behavior Problem Intellectual Disability Sexuality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Experimental: Children training

All registered participants in intervention group will participate in a series of trainings on sexuality education.

Group Type EXPERIMENTAL

Sexual Health and Development Education for Children With Intellectual Disability

Intervention Type BEHAVIORAL

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.

Control: No intervention

All registered participants in control group will not participate in a series of trainings on sexuality education.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aylin KURT

OTHER

Sponsor Role lead

Responsible Party

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Aylin KURT

Research Assistant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zonguldak Special Therapy Special Education and Rehabilitation Center

Zonguldak, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Şüheda Özer

Role: primary

+90 372 222 13 14

Related Links

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http://link.springer.com/article/10.1007/s11195-020-09638-z

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

Other Identifiers

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2020/20

Identifier Type: -

Identifier Source: org_study_id

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