NCT01772628

Brief Summary

The main objective of the study was to develop a novel intervention method which could reduce the spread of Sexually Transmitted Infections (including HIV) and unwanted pregnancies by improving parent-child communication using schools as gateways. It was done in 22 public day and mixed secondary schools in both Kampala and Wakiso districts. The study employed a cluster randomized controlled trial experimental design. Eligible schools were purposively selected and stratified into urban, peri-urban and rural. The schools were then matched into pairs for potential confounding variables such as religion and gender. In total, 11 schools were randomly allocated to the intervention and an equal number of schools to the comparison arms of the study. A questionnaire was administered to students at baseline and post-intervention. This questionnaire was validated in test re-test on approximately 200 S1 students from 2 schools that did not participate in the intervention nor the comparison arm. A parents'/guardians' questionnaire was also administered both at baseline then at post intervention. This questionnaire was also pre-tested among approximately 200 parents of S1 students who participated in the test re-test. The results of the pre-test were used to finalize the questionnaire. To increase the extent to which questions were understood, the English versions of questionnaires were translated into one of the widely spoken local language Luganda.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

January 17, 2013

Last Update Submit

March 1, 2013

Conditions

Keywords

CommunicationHealthy sexual behaviourSexual and reproductive healthAdolescents

Outcome Measures

Primary Outcomes (1)

  • Evidence of increased frequency of parent-child communication about sex and sexual risk reduction strategies after implementation of intervention components

    To determine whether assignment homework were effective in enhancing parent-child communication. Repeated measures analysis of variance will be done to assess the effects of time (baseline vs. post-intervention) and whether school-based intervention had any impact. The analysis will include all adolescents from the intervention schools irrespective of whether or not they completed the homework with their parents. To determine whether both males and females would equally benefit, gender will be included in the analysis as an independent variable. Finally, since student's demographic and baseline characteristics are likely to influence their likelihood of completing homework, post-hoc comparisons will be made controlling for these factors to determine dose-response relationships.

    Up to 14 weeks after intervening in 11 intervention schools

Secondary Outcomes (1)

  • Evidence of intentions to delay sexual debut after intervention

    14 weeks after intervention in 11 intervention schools

Other Outcomes (1)

  • Positive change in knowledge and attitudes about condoms after intervention

    14 weeks after implementation of STI/HIV prevention education intervention component

Study Arms (2)

Promoting parent-child communication

EXPERIMENTAL

This is the arm in which all interventions of Promoting parent-child communication on selected sexual and reproductive health issues among young secondary school adolescents in Kampala and Wakiso Districts were implemented. The interventions included; classroom-based component, STI/HIV prevention education, parenting component and homework assignment component.

Behavioral: Classroom-based componentBehavioral: STI/HIV prevention educationBehavioral: Homework assignment componentBehavioral: Parenting component

Comparison

NO INTERVENTION

The 11 comparison schools did not receive any form of intervention. Instead the students continued with the official standard school curriculum and regular parent/guardian involvement in school activities. No homework assignments were given to the senior one students.

Interventions

Selected topics about sex, communication, and relationships were integrated in 8 English classroom lessons and 8 Christian Religious Education classroom lessons. The component was implemented in a period of 14 weeks in Senior One classrooms of all the 11 intervention schools.

Promoting parent-child communication

For this component, the project partnered with Naguru Teenage information and Health Centre a local NGO providing "youth friendly" Sexual Reproductive Health services. The STI/HIV prevention education was implemented once in each school on a day that had been agreed upon with the school administration.

Promoting parent-child communication

This component was to facilitate open parent-child interactions and encourage interpersonal learning in a friendly home environment about selected Sexual Reproductive Health issues. Homework assignments were developed on the basis of the topics covered in the learners' component. Students were asked to discuss each assignment with their parents/guardians and recorded answers in 32 paged exercise books provided by the project which were eventually handed over to the researchers at the end of the intervention. Students were given 8 English homework assignments and 7 Christian Religious Education homework assignments.

Promoting parent-child communication

Three one day parenting workshops were conducted in each of the 11 schools for parents/guardians during the period in which the lessons were being implemented. First workshop was conducted at the beginning of the intervention, the second in the middle of the intervention and the third at the end of the intervention. Each workshop in a school was facilitated by one selected teacher and one selected parent in the school. In the first workshop a brochure about the intervention was distributed to all the parents/guardians in attendance.

Promoting parent-child communication

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Public day school
  • Mixed secondary schools located in Kampala and Wakiso districts
  • Parents/guardians provide written consent

You may not qualify if:

  • Decline to consent
  • Decline to assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences

Kampala, 256, Uganda

Location

Related Publications (1)

  • Aaro LE, Mathews C, Kaaya S, Katahoire AR, Onya H, Abraham C, Klepp KI, Wubs A, Eggers SM, de Vries H. Promoting sexual and reproductive health among adolescents in southern and eastern Africa (PREPARE): project design and conceptual framework. BMC Public Health. 2014 Jan 18;14:54. doi: 10.1186/1471-2458-14-54.

MeSH Terms

Conditions

CommunicationCoitus

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Study Officials

  • Anne R Katahoire, PhD

    Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Wilson W Muhwezi, PhD

    Makerere University College of Health Sciences School of Medicine, Department of Psychiatry

    PRINCIPAL INVESTIGATOR
  • Cecily Banura, PhD

    Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Professor

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

March 1, 2014

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations