NCT01432756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 9, 2015

Completed
Last Updated

September 9, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

September 7, 2011

Results QC Date

July 10, 2015

Last Update Submit

August 7, 2015

Conditions

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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 Worskite Parenting Program

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stellenbosch University

Stellenbosch, Cape Town, 7503, South Africa

Location

Results Point of Contact

Title
Laura Bogart
Organization
Boston Children's Hospital

Study Officials

  • Laura M. Bogart, PhD

    Children's Hospital Boston/Harvard Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Research Director, Division of General Pediatrics, Boston Children's Hospital

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 9, 2015

Results First Posted

September 9, 2015

Record last verified: 2015-08

Locations