Child Behavior ProblemNCT04635969
Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
A study testing Sexual Health and Development Education for Children With Intellectual Disability in people with Child Behavior Problem and Intellectual Disability, run by Aylin KURT at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Problem, Intellectual Disability, Sexuality
- What is being tested?
- Sexual Health and Development Education for Children With Intellectual Disability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zonguldak Special Therapy Special Education and Rehabilitation Center
Zonguldak, 67600
Şüheda Özer, +90 372 222 13 14, aylinkurt67@gmail.com
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Child Behavior Problem, Intellectual Disability, Sexuality
- Being tested
- Sexual Health and Development Education for Children With Intellectual Disability
- Medical subject headings
- Intellectual Disability, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health and Development Education for Children With Intellectual DisabilityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Children training | Experimental | All registered participants in intervention group will participate in a series of trainings on sexuality education. Receives: Behavioral: Sexual Health and Development Education for Children With Intellectual Disability |
| Control: No intervention | No intervention | All registered participants in control group will not participate in a series of trainings on sexuality education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start15 Feb 2021
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aylin KURT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aylin KURT, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635969
- Sponsor's protocol ID
- 2020/20
- Status last verified
- Jun 2022
- First submitted
- 16 Nov 2020
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability
- ClinicalTrials.gov ID
- NCT04635969
- Acronym / sponsor ID
- 2020/20
- Conditions
- Child Behavior Problem, Intellectual Disability, Sexuality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aylin KURTUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Children training | Experimental | Behavioral: Sexual Health and Development Education for Children With Intellectual DisabilityAll registered participants in intervention group will participate in a series of trainings on sexuality education. |
| Control: No intervention | No intervention | –All registered participants in control group will not participate in a series of trainings on sexuality education. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Health and Development Education for Children With Intellectual DisabilitySexual 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. | Behavioural | Experimental: Children training |
Primary outcome
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
Time frame: 12 months
"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.
Difference between the mean score of the "Sexual Development Characteristics Scale of Children with Intellectual Disability in Adolescence" between intervention and control groups
Time frame: 12 months
"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.
1 secondary outcome
Children achieve 70% success in questions about education after each training
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Sexual Education and Development in Children with Intellectual Disability: Mothers' OpinionsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zonguldak Special Therapy Special Education and Rehabilitation Center
Zonguldak, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health and Development Education for Children With Intellectual Disability in people with Child Behavior Problem and Intellectual Disability, run by Aylin KURT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.