Delay in Sexual Debut Among Adolescents Clinical Trial
Official title:
Promoting Parent-Child Communication on Selected Sexual and Reproductive Health Issues Among Young Secondary School Adolescents in Kampala and Wakiso Districts
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.
Various studies and reviews conducted mainly in developed countries have demonstrated that
parent-child communication complimented by school based comprehensive sex education programs
aimed at delay in sexual debut and promotion of safer sex practices work. However, there is
limited information about such studies in developing countries like Uganda.
The Randomized Controlled Trial targeted 2 populations; students admitted to S1 in 2012 and
their parents. Specifically the Randomized Controlled Trial aimed to (i) increase proportion
of students with intentions to delay sexual debut (ii) increase knowledge and influence
attitudes of adolescents about condoms (iii) increase the frequency of parent-child
communication (iv) improve the quality of parent-child communication through structured
homework.
The Randomized Controlled Trial comprised 3 components: the classroom-based component; the
parent component and the homework assignment component. Sexual and reproductive health
topics were integrated in 8 English and 8 Christian Religious education double lessons
lasting 90 minutes. For each lesson there was a corresponding homework that a student was
expected to complete with their parent/guardian. Teachers were re-trained in pedagogical
skills in preparation for implementation of the intervention. At the same time, parents were
trained in communication skills and assisted to improve their parenting skills in 3 one-day
workshops. The 11 schools randomized to comparison schools will have delayed intervention. A
pre- and post-intervention survey was conducted for both students using a standardized
questionnaire to assess changes in parent-child communication as well as knowledge,
attitudes and intentions to delay sexual debut. A simultaneous pre-and post intervention
survey using a standardized questionnaire was also conducted among parents of students
participating in the intervention to assess change in communication with their children and
parenting practices. For every component, quantitative and qualitative data was collected to
evaluate the processes of delivering the evaluation.
Statistical analysis will be carried out using appropriate statistical software. Frequencies
and means when appropriate will be calculated for each variable and for summary scale at
baseline and post-intervention measurements. Inter-item correlation coefficients for each
scale will be assessed using Cronbach's alpha. T-test for mean differences, kappa statistics
and McNemar test for non-independent samples will be used to assess changes in knowledge,
attitudes and intentions between baseline and post-intervention. Content analysis will be
done for homework.
The results from this intervention will contribute to Millennium Development Goals 2, 4, 6
and 6, which aims to combat HIV/AIDS and other diseases, maternal and child deaths and by
focusing on education and involving school teachers, the study will also contribute towards
the quality aspects universal primary education.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention