Clinical trial NCT01772628: Parenting Styles and Parent-Offspring Communication on Sexuality Issues
Official title: Promoting Parent-Child Communication on Selected Sexual and Reproductive Health Issues Among Young Secondary School Adolescents in Kampala and Wakiso Districts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delay in Sexual Debut Among Adolescents
Knowledge About Condom Use
Parent-child Communication, Frequency and Quality
Keywords: Communication
Healthy sexual behaviour
Sexual and reproductive health
Adolescents
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Oslo
name: University of Cape Town
name: University of Limpopo
name: Muhimbili University of Health and Allied Sciences
name: Maastricht University
name: University of Sussex
First posted: 2013-01-21
Enrollment: 1700
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of increased frequency of parent-child communication about sex and sexual risk reduction strategies after implementation of intervention components
timeFrame: Up to 14 weeks after intervening in 11 intervention schools
Secondary outcomes:
measure: Evidence of intentions to delay sexual debut after intervention
timeFrame: 14 weeks after intervention in 11 intervention schools
Other outcomes:
measure: Positive change in knowledge and attitudes about condoms after intervention
timeFrame: 14 weeks after implementation of STI/HIV prevention education intervention component
Locations:
city: Kampala
country: Uganda
facility: Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
Study officials:
affiliation: Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
name: Anne R Katahoire, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University College of Health Sciences School of Medicine, Department of Psychiatry
name: Wilson W Muhwezi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
name: Cecily Banura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.