Relationship Problems Specific to Childhood and AdolescenceNCT03669913
Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents
A study testing Lessons on comprehensive sexuality education in people with Relationship Problems Specific to Childhood and Adolescence, run by Mbarara University of Science and Technology.
Trial summary
This study evaluates the effectiveness of comprehensive sexuality education (CSE) among young adolescents (10-14 years) in schools. A total of 33 schools will participate in the trial with 15 intervention arm that will receive CSE education and 18 in the control arm, Intervention will go on for one year Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Relationship Problems Specific to Childhood and Adolescence
- What is being tested?
- Lessons on comprehensive sexuality education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2015to 31 Dec 2018
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- adolescent 10-14 years in primary school
- Adolescent in primary 5 or 6 of education in Uganda
- Written consent/assent to participate
Who cannot join
- Below 10 years or above 14 years at baseline
- No consent obtained
About this study
Official title: Mitigating Adverse Sexual and Reproductive Health Outcomes Through a Comprehensive Primary School Sexuality Education Program in South-Western Uganda
This study evaluates the effectiveness of comprehensive sexuality education (CSE) among young adolescents (10-14 years) in schools. A total of 33 schools will participate in the trial with 15 intervention arm that will receive CSE education and 18 in the control arm, Intervention will go on for one year
Read the detailed description
The International Technical Guidance on Sexuality Education (ITGSE) defines CSE as "an age-appropriate, culturally relevant approach to teaching about sexuality and relationships by providing scientifically accurate, realistic, non-judgmental information and CSE improves sexual and reproductive health outcomes of young people by delaying sexual debut, promoting condom use and increasing sexual health knowledge, however, most of these outcomes have been reported in older adolescents and there is limited evidence for effectiveness of CSE among young adolescents
The study aims at improving adolescent sexual and reproductive health of young adolescents through CSE that is led by interdisciplinary university students' team in an environment where no consistent or regulated sexual and reproductive health education program currently exists
- Being tested
- Lessons on comprehensive sexuality education
- Keywords
- sexuality, education, adolescents
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lessons on comprehensive sexuality educationOther
Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention arm will receive a pre evaluation survey, 11 lessons on CSE sequentially in a period of one year and a post evaluation survey Receives: Other: Lessons on comprehensive sexuality education |
| Control arm | No intervention | This is a control arm that receives no intervention but will have and pre and post evaluation in one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sexual health knowledge by 15% from baseline
change in sexual health knowledge(HIV, STI, contraception and puberty knowledge) using an itemized questionnaire developed for the study. The estimated knowlege score will be 25 . Individual items include on knowledge of puberty, HIV/STIs and pregnancy prevention. This includes knowledge on how HIV/AIDS can be acquired (score 0-4), types of common Sexually Transmitted Infections (score 0-4), knowledge of pubertal changes in boys (score 0-6.) and in girls (score 0-7), and knowledge about ways to prevent pregnancy (score 0-4)
Measured: one year
Secondary outcomes (4)
Change in proportion of sexually active adolescents by 10% from baseline
Change in number of those who are sexually active
Measured: one year
Change in gender equitable norm scores by 10% from baseline
Adolescents to adopt a more gender equitable norm attitude. Gender equitable norms scale will be developed on a 4 likert point scale and total scores will range from 0 to 44. The higher the score, the higher the tendency to have gender equitable norms. The score consists of 11 items. Six of these items were adapted from the Attitudes towards Women Scale for Adolescents (AWSA) by Galambos NL et al., 1985 while 5 items were developed to suit the respondents' age and the Ugandan context.
Measured: one year
change in body image scores by 10% from baseline
Adolescents develop a more positive attitude in appreciation of their body size or shape.The items for this scale were adapted from the Body Image States Scale (BISS-6) by Cash TF et al, 2002 but transformed to a 5 point likert scale including a neutral point for ease of use among respondents. The total expected score was 24 and the higher the score the better the body image
Measured: one year
change in self esteem scores by 10% from baseline
Adolescent develop confidence in themselves and their abilities. Self esteem score used was developed by Rosenberg M et al., 1965. The total expected score for the 10 items was 40. The higher the score the better the self esteem
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start8 Nov 2015
- Primary completion30 Nov 2017
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relationship Problems Specific to Childhood and AdolescenceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Free University of Brussels
- Responsible party
- Sponsor
- Investigators
- Kristien Michielsen, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669913
- Sponsor's protocol ID
- MUST 04/10-15
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be discretely shared with other researchers on request
Publications
Rosenberg M. Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package. 1965;61:52.
Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
PubMed 16864251Galambos NL, Petersen AC, Richards M, Gitelson IB. The Attitudes Toward Women Scale for Adolescents (AWSA): A study of reliability and validity. Sex roles. 1985;13(5):343-356.
Kemigisha E, Nyakato VN, Bruce K, Ndaruhutse Ruzaaza G, Mlahagwa W, Ninsiima AB, Coene G, Leye E, Michielsen K. Adolescents' Sexual Wellbeing in Southwestern Uganda: A Cross-Sectional Assessment of Body Image, Self-Esteem and Gender Equitable Norms. Int J Environ Res Public Health. 2018 Feb 22;15(2):372. doi: 10.3390/ijerph15020372.
PubMed 29470388
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Adverse Sexual and Reproductive Health Outcomes Through a Comprehensive Primary School Sexuality Education Program in South-Western Uganda
- ClinicalTrials.gov ID
- NCT03669913
- Acronym / sponsor ID
- MUST 04/10-15
- Keywords
- sexuality, education, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University Ghent, Free University of Brussels
- Study start
- 8 Nov 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 Sep 2018 (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.
This study evaluates the effectiveness of comprehensive sexuality education (CSE) among young adolescents (10-14 years) in schools. A total of 33 schools will participate in the trial with 15 intervention arm that will receive CSE education and 18 in the control arm, Intervention will go on for one year
Detailed description
The International Technical Guidance on Sexuality Education (ITGSE) defines CSE as "an age-appropriate, culturally relevant approach to teaching about sexuality and relationships by providing scientifically accurate, realistic, non-judgmental information and CSE improves sexual and reproductive health outcomes of young people by delaying sexual debut, promoting condom use and increasing sexual health knowledge, however, most of these outcomes have been reported in older adolescents and there is limited evidence for effectiveness of CSE among young adolescents
The study aims at improving adolescent sexual and reproductive health of young adolescents through CSE that is led by interdisciplinary university students' team in an environment where no consistent or regulated sexual and reproductive health education program currently exists
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Lessons on comprehensive sexuality educationIntervention arm will receive a pre evaluation survey, 11 lessons on CSE sequentially in a period of one year and a post evaluation survey |
| Control arm | No intervention | –This is a control arm that receives no intervention but will have and pre and post evaluation in one year |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- adolescent 10-14 years in primary school
- Adolescent in primary 5 or 6 of education in Uganda
- Written consent/assent to participate
Key exclusion criteria (2 listed)
- Below 10 years or above 14 years at baseline
- No consent obtained
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 |
|---|---|---|
| Lessons on comprehensive sexuality educationProvision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO | Other | Intervention |
Primary outcome
change in sexual health knowledge by 15% from baseline
Time frame: one year
change in sexual health knowledge(HIV, STI, contraception and puberty knowledge) using an itemized questionnaire developed for the study. The estimated knowlege score will be 25 . Individual items include on knowledge of puberty, HIV/STIs and pregnancy prevention. This includes knowledge on how HIV/AIDS can be acquired (score 0-4), types of common Sexually Transmitted Infections (score 0-4), knowledge of pubertal changes in boys (score 0-6.) and in girls (score 0-7), and knowledge about ways to prevent pregnancy (score 0-4)
4 secondary outcomes
Change in proportion of sexually active adolescents by 10% from baseline
Time frame: one year
Change in gender equitable norm scores by 10% from baseline
Time frame: one year
change in body image scores by 10% from baseline
Time frame: one year
change in self esteem scores by 10% from baseline
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- BackgroundRosenberg M. Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package. 1965;61:52.
- Background: PubMed 16864251Cash TF, Fleming EC, Alindogan J, Steadman L, Whitehead A. Beyond body image as a trait: the development and validation of the Body Image States Scale. Eat Disord. 2002 Summer;10(2):103-13. doi: 10.1080/10640260290081678.
- BackgroundGalambos NL, Petersen AC, Richards M, Gitelson IB. The Attitudes Toward Women Scale for Adolescents (AWSA): A study of reliability and validity. Sex roles. 1985;13(5):343-356.
- Background: PubMed 29470388Kemigisha E, Nyakato VN, Bruce K, Ndaruhutse Ruzaaza G, Mlahagwa W, Ninsiima AB, Coene G, Leye E, Michielsen K. Adolescents' Sexual Wellbeing in Southwestern Uganda: A Cross-Sectional Assessment of Body Image, Self-Esteem and Gender Equitable Norms. Int J Environ Res Public Health. 2018 Feb 22;15(2):372. doi: 10.3390/ijerph15020372.
- Individual participant dataSharing planned: Undecided. Data will be discretely shared with other researchers on request
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.
Kristien Michielsen, PhD principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Lessons on comprehensive sexuality education in people with Relationship Problems Specific to Childhood and Adolescence, run by Mbarara University of Science and Technology.
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 3 inclusion and 2 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sexual health knowledge by 15% from baseline (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669913, which also lists 4 linked publications.
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 13 Sep 2018.