Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

NCT ID: NCT03669913

Last Updated: 2018-09-13

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

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-08

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Relationship Problems Specific to Childhood and Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Intervention arm will receive a pre evaluation survey, 11 lessons on CSE sequentially in a period of one year and a post evaluation survey

Group Type EXPERIMENTAL

Lessons on comprehensive sexuality education

Intervention Type OTHER

Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO

Control arm

This is a control arm that receives no intervention but will have and pre and post evaluation in one year

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lessons on comprehensive sexuality education

Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* adolescent 10-14 years in primary school
* Adolescent in primary 5 or 6 of education in Uganda
* Written consent/assent to participate

Exclusion Criteria

* Below 10 years or above 14 years at baseline
* No consent obtained
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

Free University of Brussels

OTHER

Sponsor Role collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristien Michielsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

References

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Rosenberg M. Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package. 1965;61:52.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16864251 (View on PubMed)

Galambos 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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29470388 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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MUST 04/10-15

Identifier Type: -

Identifier Source: org_study_id

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