- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432756
A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In South Africa, >5 million people, including many adolescents, are living with HIV. Prevalence is increasing throughout South Africa, most precipitously in the Western Cape, the site of our proposed study. The investigators propose to pilot test a multisession worksite-based program to help parents learn how to take an active role in rearing sexually healthy youth. Our specific aims are to: (1) Culturally adapt our US-developed worksite-based program for parents of adolescents to the South African context; (2) Examine whether a worksite-based program for parents of adolescents in South Africa improves the parent-child relationship, including general parent-child communication and communication about sexual health and HIV risk-reduction, as perceived by parents and adolescents; (3) Explore program effects on parents' HIV testing and sexual behaviors; and (4) Explore program effects on theoretically important psychosocial mediators of behavior change (e.g., greater self-efficacy for refusing sex and using condoms, and more perceived disadvantages of unprotected sex). The proposed research is a unique opportunity to adapt and pilot test an innovative HIV prevention intervention that promotes the health of families in a culturally acceptable and sustainable setting.
The research is being conducted in three phases. In Phase 1, the investigators conducted formative qualitative interviews with South African community members who work with adolescents and parents, who work on HIV prevention, and who hold relevant positions at worksites. The investigators used this information from key community members to culturally adapt the program. In Phase 2, the investigators are conducting a process evaluation of one intervention group of 15 parents using qualitative debriefing interviews and quantitative data. In Phase 3, the current phase, the investigators aim to conduct a pilot intervention to refine the program even further and test the evaluation methods with 60 Xhosa and Afrikaans-speaking parents and their 11-15-year-old adolescents (who will participate in the evaluation but not the program). Their outcomes will be compared to a wait-list control group of 60 Xhosa and Afrikaans-speaking parents and their 11-15-year-old adolescents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cape Town
-
Stellenbosch, Cape Town, South Africa, 7503
- Stellenbosch University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents: Work for City of Cape Town; Are Xhosa-speaking or Afrikaans-speaking; Have a child between the ages of 11-15 (self report); Spend at least 3 days/week with their adolescents
- Children: Eligible if they are between the ages of 11-15 (self report) and have a parent or legal guardian who works in the City of Cape Town who is enrolled in the program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait-list control
Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
|
|
Experimental: Let's Talk Worskite Parenting Program
The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children.
The 5-session program meets weekly for 2 hours.
The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use.
Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
|
The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children.
The 5-session program meets weekly for 2 hours.
The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use.
Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Topics Discussed Between Parent and Child
Time Frame: 6 months
|
Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure. For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura M. Bogart, PhD, Children's Hospital Boston/Harvard Medical School
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5R34MH090790-02 (U.S. NIH Grant/Contract)
- 5R34MH090790 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parent-Child Relations
-
Esteban Gómez MuzzioNot yet recruitingParent-Child Relations | Parenting | Parent-child Problem
-
The University of Hong KongCompletedParent-Child Relations | Child DevelopmentHong Kong
-
Government College University FaisalabadActive, not recruitingParent-Child RelationsPakistan
-
University of OttawaWithdrawnParent-Child RelationsCanada
-
National Taipei University of Nursing and Health...CompletedParent-Child Relations
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
University of CalgaryRecruitingParent-Child RelationsCanada
-
University of OttawaRecruitingParent-Child RelationsCanada
-
Universitätsklinikum Hamburg-EppendorfRecruitingParent-Child RelationsGermany
Clinical Trials on Let's Talk Worksite Parenting Program
-
Public Health Management CorporationDepartment of Health and Human ServicesCompletedPregnancy in AdolescenceUnited States
-
University of HelsinkiCompletedBurnout | Children's Wellbeing | Child Overall Health Related Quality of LifeFinland
-
Université de MontréalCanadian Institutes of Health Research (CIHR)Completed
-
University of ChicagoChildrens Services Council; St. Marys Medical Center; Soma Medical Center; Home...Withdrawn
-
Oregon Center for Applied Science, Inc.CompletedSexually Transmitted Diseases | Communication | Adolescent Pregnancy | Sexuality | ParentalUnited States
-
University of GuelphCanadian Institutes of Health Research (CIHR); Western University; Society of...Completed
-
Marmara UniversityMarmara University Scientific Research Projects Unit; THE SCIENTIFIC AND TECHNOLOGICAL...Enrolling by invitationPublic Health NursingTurkey
-
Oregon Research Behavioral Intervention Strategies...Eunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingStress | Parent-Child Relations | Child Behavior | Self Efficacy | Emotional Adjustment | Parenting Practices | Sleep ProblemsUnited States
-
Mireille JoussemetCanadian Institutes of Health Research (CIHR)RecruitingParenting | Mental Health IssueCanada