Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432756
Other study ID # 5R34MH090790-02
Secondary ID 5R34MH090790
Status Completed
Phase N/A
First received September 7, 2011
Last updated August 7, 2015
Start date September 2011
Est. completion date April 2012

Study information

Verified date August 2015
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
South Africa Stellenbosch University Stellenbosch Cape Town

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital Boston National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
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.
6 months No
See also
  Status Clinical Trial Phase
Completed NCT03905278 - Parental Support Intervention in the Oncological Context N/A
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04101799 - Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden N/A
Completed NCT01955551 - Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming Phase 2
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Completed NCT05930535 - Family-Focused Adolescent & Lifelong Health Promotion N/A
Completed NCT03658122 - Integrating Behavioral Treatment in Primary Care N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT04853888 - ATTACHâ„¢ Program: Promoting Vulnerable Children's Health at Scale N/A
Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Recruiting NCT04627415 - Project PEAK: Early Intervention for ADHD N/A
Completed NCT04257331 - Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China N/A
Withdrawn NCT05135507 - The Effective Parenting Program (EPP) N/A
Completed NCT03853564 - Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities N/A
Active, not recruiting NCT05264415 - Intergenerational Transmission of Traumatic Stress N/A
Completed NCT04342871 - An Evaluation of the Fathers and Mothers With Cancer Communication Tool N/A
Recruiting NCT04107506 - The Supporting Early Learning Study N/A
Recruiting NCT04827225 - Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child