NCT03669913

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
unknown

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

Study Start

First participant enrolled

November 8, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

September 7, 2018

Last Update Submit

September 11, 2018

Conditions

Relationship Problems Specific to Childhood and Adolescence

Keywords

sexualityeducationadolescents

Outcome Measures

Primary Outcomes (1)

  • 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)

    one year

Secondary Outcomes (4)

  • Change in proportion of sexually active adolescents by 10% from baseline

    one year

  • Change in gender equitable norm scores by 10% from baseline

    one year

  • change in body image scores by 10% from baseline

    one year

  • change in self esteem scores by 10% from baseline

    one year

Study Arms (2)

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

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

Interventions

Lessons on comprehensive sexuality educationOTHER

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

Intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Below 10 years or above 14 years at baseline
  • No consent obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

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

    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.

    PMID: 16864251BACKGROUND

  • 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.

    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.

    PMID: 29470388BACKGROUND

MeSH Terms

Conditions

Sexuality

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Kristien Michielsen, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomized trial where the intervention is structured comprehensive sexuality education lesson packages
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 13, 2018

Study Start

November 8, 2015

Primary Completion

November 30, 2017

Study Completion

December 31, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09