Delay in Sexual Debut Among AdolescentsPREPARENCT01772628
Parenting Styles and Parent-Offspring Communication on Sexuality Issues
A study testing Classroom-based component, STI/HIV prevention education and Homework assignment component in people with Delay in Sexual Debut Among Adolescents and Knowledge About Condom Use, run by Child Health & Development Centre at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Delay in Sexual Debut Among Adolescents, Knowledge About Condom Use, Parent-child Communication, Frequency and Quality
- What is being tested?
- Classroom-based component, STI/HIV prevention education and Homework assignment component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Public day school
- Mixed secondary schools located in Kampala and Wakiso districts
- Parents/guardians provide written consent
Who cannot join
- Decline to consent
- Decline to assent
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
Kampala, 256
About this study
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.
Read the 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.
- Conditions
- Delay in Sexual Debut Among Adolescents, Knowledge About Condom Use, Parent-child Communication, Frequency and Quality
- Being tested
- Classroom-based component, STI/HIV prevention education, Homework assignment component, Parenting component
- Keywords
- Communication, Healthy sexual behaviour, Sexual and reproductive health, Adolescents
- Medical subject headings
- Communication, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classroom-based componentBehavioural
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.
STI/HIV prevention educationBehavioural
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.
Homework assignment componentBehavioural
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.
Parenting componentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Classroom-based component; Behavioral: STI/HIV prevention education; Behavioral: Homework assignment component; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks after intervening in 11 intervention schools
Secondary outcomes (1)
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.
Measured: 14 weeks after intervention in 11 intervention schools
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delay in Sexual Debut Among AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Health & Development Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, University of Oslo, University of Cape Town, University of Limpopo, Muhimbili University of Health and Allied Sciences, Maastricht University, University of Sussex
- Responsible party
- Sponsor-investigator, Child Health & Development Centre, Makerere University
- Investigators
- Anne R Katahoire, PhD, Principal investigator, Child Health and Development Centre, School of Medicine, Makerere University College of Health SciencesWilson W Muhwezi, PhD, Principal investigator, Makerere University College of Health Sciences School of Medicine, Department of PsychiatryCecily Banura, PhD, Principal investigator, Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772628
- Sponsor's protocol ID
- 241945 PREPARE
- Acronym
- PREPARE
- Status last verified
- Mar 2013
- First submitted
- 17 Jan 2013
- Last updated
- 4 Mar 2013
- Results posted
- No
Publications
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.
PubMed 24438582
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Parent-Child Communication on Selected Sexual and Reproductive Health Issues Among Young Secondary School Adolescents in Kampala and Wakiso Districts
- ClinicalTrials.gov ID
- NCT01772628
- Acronym / sponsor ID
- PREPARE / 241945 PREPARE
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Child Health & Development CentreUniversity, hospital or other
- Collaborators
- University of Bergen, University of Oslo, University of Cape Town, University of Limpopo, Muhimbili University of Health and Allied Sciences, Maastricht University, University of Sussex
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Mar 2014 (estimated)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promoting parent-child communication | Experimental | Behavioral: Classroom-based component, Behavioral: STI/HIV prevention education, Behavioral: Homework assignment component, Behavioral: Parenting componentThis 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. |
| 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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Public day school
- Mixed secondary schools located in Kampala and Wakiso districts
- Parents/guardians provide written consent
Key exclusion criteria (2 listed)
- Decline to consent
- Decline to assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classroom-based componentSelected 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. | Behavioural | Promoting parent-child communication |
| STI/HIV prevention educationFor 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. | Behavioural | Promoting parent-child communication |
| Homework assignment componentThis 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. | Behavioural | Promoting parent-child communication |
| Parenting componentThree 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. | Behavioural | Promoting parent-child communication |
Primary outcome
Evidence of increased frequency of parent-child communication about sex and sexual risk reduction strategies after implementation of intervention components
Time frame: 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.
1 secondary outcome
Evidence of intentions to delay sexual debut after intervention
Time frame: 14 weeks after intervention in 11 intervention schools
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Derived from this study: PubMed 24438582Aaro 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne R Katahoire, PhD principal investigator
Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
Wilson W Muhwezi, PhD principal investigator
Makerere University College of Health Sciences School of Medicine, Department of Psychiatry
Cecily Banura, PhD principal investigator
Child Health and Development Centre, School of Medicine, Makerere University College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classroom-based component, STI/HIV prevention education and Homework assignment component in people with Delay in Sexual Debut Among Adolescents and Knowledge About Condom Use, run by Child Health & Development Centre at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of increased frequency of parent-child communication about sex and sexual risk reduction strategies after implementation of intervention components (time frame: Up to 14 weeks after intervening in 11 intervention schools). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.