A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents

This study is currently recruiting participants.
Verified September 2011 by Children's Hospital Boston
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01432756
First received: September 7, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

The investigators hypothesize that participants in the worksite parenting program intervention will show significantly better parent-child communication than will participants in the no-treatment (wait-list) control group.


Condition Intervention
Parent-Child Relations
Behavioral: Let's Talk Worksite Parenting Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Parent-Child Communication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured using Parent-Adolescent Communication scales (including general communication and communication on sexual topics that the intervention covers) for both parent and child participants in pre- and post-assessments


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Let's Talk Worksite 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.

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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432756

Contacts
Contact: Laura M Bogart, PhD 857-218-4073 laura.bogart@childrens.harvard.edu
Contact: Donald Skinner, PhD dskinner@sun.ac.za

Locations
South Africa
Stellenbosch University Recruiting
Stellenbosch, Cape Town, South Africa, 7503
Contact: Donald Skinner, PhD         dskinner@sun.ac.za    
Principal Investigator: Donald Skinner, PhD            
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Laura M. Bogart, PhD Children's Hospital Boston/Harvard Medical School
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01432756     History of Changes
Other Study ID Numbers: 5R34MH090790-02
Study First Received: September 7, 2011
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
HIV

ClinicalTrials.gov processed this record on March 14, 2013