Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 14, 2022
June 1, 2022
1.4 years
November 16, 2020
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Children achieve 70% success in questions about education after each training
12 months
Study Arms (2)
Experimental: Children training
EXPERIMENTALAll registered participants in intervention group will participate in a series of trainings on sexuality education.
Control: No intervention
NO INTERVENTIONAll registered participants in control group will not participate in a series of trainings on sexuality education.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aylin KURTlead
Study Sites (1)
Zonguldak Special Therapy Special Education and Rehabilitation Center
Zonguldak, 67600, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 19, 2020
Study Start
February 15, 2021
Primary Completion
July 1, 2022
Study Completion
August 1, 2022
Last Updated
June 14, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12 months