A South African Pilot Worksite Parenting Program to Preve... | NCT01432756

NCT01432756

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
5R34MH090790	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institutes of Health (NIH)	NIH
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Wait-list control	No Intervention	Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
Let's Talk Worskite Parenting Program	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Let's Talk Worksite Parenting Program	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	6 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Laura M. Bogart, PhD	Children's Hospital Boston/Harvard Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stellenbosch University		Stellenbosch	Cape Town	7503	South Africa

Arm/Group Information

ID	Title	Description
FG000	Wait-list Control - Parent Participants	Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
FG001	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;
FG002	Wait-list Control - Adolescent Partipants	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.
FG003	Let's Talk Worksite Parenting Program - Adolescent Participant	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00032 subjects FG00134 subjects FG00232 subjects FG00334 subjects
COMPLETED		FG00031 subjects FG00134 subjects FG00230 subjects FG00333 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects FG0022 subjects FG0031 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0001 subjects FG0010 subjects FG0022 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	Let's Talk Worskite Parenting Program - Parent Participants

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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

Posted

Mean

Standard Deviation

number of sex and HIV topics discussed

6 months

ID	Title	Description
OG000	Wait-list Control - Parent Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Wait-list Control	Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.

Title	Organization	Phone	Extension	Email
Laura Bogart	Boston Children's Hospital	857-218-4073		laura.bogart@childrens.harvard.edu

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;