Delay in Sexual Debut Among Adolescents Clinical Trial
— PREPAREOfficial title:
Promoting Parent-Child Communication on Selected Sexual and Reproductive Health Issues Among Young Secondary School Adolescents in Kampala and Wakiso Districts
| Verified date | March 2013 |
| Source | Makerere University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Uganda: National Council for Science and Technology |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1700 |
| Est. completion date | March 2014 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 14 Years |
| Eligibility |
Inclusion Criteria: - Public day school - Mixed secondary schools located in Kampala and Wakiso districts - Parents/guardians provide written consent Exclusion Criteria: - Decline to consent - Decline to assent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Uganda | Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences | Kampala |
| Lead Sponsor | Collaborator |
|---|---|
| Child Health & Development Centre | Maastricht University, Muhimbili University of Health and Allied Sciences, University of Bergen, University of Cape Town, University of Limpopo, University of Oslo, University of Sussex |
Uganda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Positive change in knowledge and attitudes about condoms after intervention | 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 and attitudes between baseline and post-intervention. | 14 weeks after implementation of STI/HIV prevention education intervention component | No |
| Primary | 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 | No |
| Secondary | Evidence of intentions to delay sexual debut after intervention | 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. | 14 weeks after intervention in 11 intervention schools | No |