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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laura Bogart, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01432756
First received: September 7, 2011
Last updated: August 7, 2015
Last verified: August 2015
Results First Received: July 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Prevention
Condition: Parent-Child Relations
Intervention: Behavioral: Let's Talk Worksite Parenting Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Wait-list Control - Parent Participants     Let's Talk Worskite Parenting Program - Parent Participants     Wait-list Control - Adolescent Partipants     Let's Talk Worksite Parenting Program - Adolescent Participant  
STARTED     32     34     32     34  
COMPLETED     31     34     30     33  
NOT COMPLETED     1     0     2     1  
Lost to Follow-up                 1                 0                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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 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

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 Total of all reporting groups

Baseline Measures
    Wait-list Control - Parent Participants     Let's Talk Worskite Parenting Program - Parent Participants     Wait-list Control - Adolescent Participants     Let's Talk Worksite Parenting Program -Adolescent Participants     Total  
Number of Participants  
[units: participants]
  32     34     32     34     132  
Age  
[units: participants]
         
<=18 years     0     0     32     34     66  
Between 18 and 65 years     32     34     0     0     66  
>=65 years     0     0     0     0     0  
Gender  
[units: participants]
         
Female     12     12     16     13     53  
Male     20     22     16     21     79  
Region of Enrollment  
[units: participants]
         
South Africa     32     34     32     34     132  



  Outcome Measures

1.  Primary:   Number of Topics Discussed Between Parent and Child   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Laura Bogart
Organization: Boston Children's Hospital
phone: 857-218-4073
e-mail: laura.bogart@childrens.harvard.edu



Responsible Party: Laura Bogart, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01432756     History of Changes
Other Study ID Numbers: 5R34MH090790-02 ( US NIH Grant/Contract Award Number )
5R34MH090790 ( US NIH Grant/Contract Award Number )
Study First Received: September 7, 2011
Results First Received: July 10, 2015
Last Updated: August 7, 2015
Health Authority: United States: Institutional Review Board