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临床试验/NCT01772628
NCT01772628Unknown不适用

Promoting Parent-Child Communication on Selected Sexual and Reproductive Health Issues Among Young Secondary School Adolescents in Kampala and Wakiso Districts

Child Health & Development Centre2 个研究点 分布在 1 个国家目标入组 1,700 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,700
试验地点
2
主要终点
Evidence of increased frequency of parent-child communication about sex and sexual risk reduction strategies after implementation of intervention components

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Decline to consent
  • Decline to assent

结局指标

主要结局

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

时间窗: Up to 14 weeks after intervening in 11 intervention schools

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.

次要结局

  • Evidence of intentions to delay sexual debut after intervention(14 weeks after intervention in 11 intervention schools)

研究者

发起方
Child Health & Development Centre
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Child Health & Development Centre

Assoc. Professor

Makerere University

研究点 (2)

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