Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01432756
Enrollment
132
Registered
2011-09-13
Start date
2011-09-30
Completion date
2012-04-30
Last updated
2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parent-Child Relations

Keywords

HIV

Brief summary

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.

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.

Interventions

BEHAVIORALLet'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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Topics Discussed Between Parent and Child6 monthsMeasured 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.

Countries

South Africa

Participant flow

Participants by arm

ArmCount
Wait-list Control - Parent Participants
Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
32
Let's Talk Worskite Parenting Program - Parent Participants
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. 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;
34
Wait-list Control - Adolescent Participants
Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
32
Let's Talk Worksite Parenting Program -Adolescent Participants
Adolescent participants will have parents who are in the 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.
34
Total132

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up1021

Baseline characteristics

CharacteristicWait-list Control - Parent ParticipantsLet's Talk Worskite Parenting Program - Parent ParticipantsWait-list Control - Adolescent ParticipantsLet's Talk Worksite Parenting Program -Adolescent ParticipantsTotal
Age, Categorical
<=18 years
0 Participants0 Participants32 Participants34 Participants66 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
32 Participants34 Participants0 Participants0 Participants66 Participants
Region of Enrollment
South Africa
32 participants34 participants32 participants34 participants132 participants
Sex: Female, Male
Female
12 Participants12 Participants16 Participants13 Participants53 Participants
Sex: Female, Male
Male
20 Participants22 Participants16 Participants21 Participants79 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 640 / 68
serious
Total, serious adverse events
0 / 640 / 68

Outcome results

Primary

Number of Topics Discussed Between Parent and Child

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.

Time frame: 6 months

Population: Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.

ArmMeasureGroupValue (MEAN)Dispersion
Wait-list Control - Parent ParticipantsNumber of Topics Discussed Between Parent and ChildBaseline8.3 number of sex and HIV topics discussedStandard Deviation 5.7
Wait-list Control - Parent ParticipantsNumber of Topics Discussed Between Parent and ChildFirst Follow-up9.3 number of sex and HIV topics discussedStandard Deviation 5.7
Let's Talk Worskite Parenting Program - Parent ParticipantsNumber of Topics Discussed Between Parent and ChildFirst Follow-up12.4 number of sex and HIV topics discussedStandard Deviation 4.3
Let's Talk Worskite Parenting Program - Parent ParticipantsNumber of Topics Discussed Between Parent and ChildBaseline7.8 number of sex and HIV topics discussedStandard Deviation 4.8
Wait-list Control - Adolescent ParticipantsNumber of Topics Discussed Between Parent and ChildBaseline9.4 number of sex and HIV topics discussedStandard Deviation 4
Wait-list Control - Adolescent ParticipantsNumber of Topics Discussed Between Parent and ChildFirst Follow-up9.2 number of sex and HIV topics discussedStandard Deviation 5.1
Let's Talk Worksite Parenting Program -Adolescent ParticipantsNumber of Topics Discussed Between Parent and ChildBaseline7.2 number of sex and HIV topics discussedStandard Deviation 4.7
Let's Talk Worksite Parenting Program -Adolescent ParticipantsNumber of Topics Discussed Between Parent and ChildFirst Follow-up9.2 number of sex and HIV topics discussedStandard Deviation 4.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026