Trial Outcomes & Findings for A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents (NCT NCT01432756)
NCT ID: NCT01432756
Last Updated: 2015-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
6 months
Results posted on
2015-09-09
Participant Flow
Participant milestones
| Measure |
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.
|
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;
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
32
|
34
|
|
Overall Study
COMPLETED
|
31
|
34
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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;
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
1
|
Baseline Characteristics
A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents
Baseline characteristics by cohort
| Measure |
Wait-list Control - Parent Participants
n=32 Participants
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 - Parent Participants
n=34 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;
|
Wait-list Control - Adolescent Participants
n=32 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.
|
Let's Talk Worksite Parenting Program -Adolescent Participants
n=34 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.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
32 participants
n=5 Participants
|
34 participants
n=4 Participants
|
132 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.
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.
Outcome measures
| Measure |
Wait-list Control - Parent Participants
n=32 Participants
Parent 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 - Parent Participants
n=34 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;
|
Wait-list Control - Adolescent Participants
n=32 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.
|
Let's Talk Worksite Parenting Program -Adolescent Participants
n=34 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.
|
|---|---|---|---|---|
|
Number of Topics Discussed Between Parent and Child
Baseline
|
8.3 number of sex and HIV topics discussed
Standard Deviation 5.7
|
7.8 number of sex and HIV topics discussed
Standard Deviation 4.8
|
9.4 number of sex and HIV topics discussed
Standard Deviation 4.0
|
7.2 number of sex and HIV topics discussed
Standard Deviation 4.7
|
|
Number of Topics Discussed Between Parent and Child
First Follow-up
|
9.3 number of sex and HIV topics discussed
Standard Deviation 5.7
|
12.4 number of sex and HIV topics discussed
Standard Deviation 4.3
|
9.2 number of sex and HIV topics discussed
Standard Deviation 5.1
|
9.2 number of sex and HIV topics discussed
Standard Deviation 4.8
|
Adverse Events
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Let's Talk Worskite Parenting Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place