PLH for Teens - Hybrid Delivery

Status Completed

Clinical Trial Summary

This study aims to examine the implementation and effectiveness of the original version of PLH Teens delivered in-person (PLH Teens-Original) and a hybrid in-person and remote delivery of the programme (PLH Teens-Hybrid) as part of the Mothers2Mothers' (M2M) Children and Adolescents are My Priority (CHAMP) project in Mpumalanga, South Africa. It will also examine differential effects between PLH Teens-Original and PLH Teens-Hybrid on reducing risks of violence against children using propensity score matching. Lastly, it will examine the implementation feasibility of PLH Teens-Hybrid in terms of implementation fidelity; recruitment, retention, and engagement of parents and adolescents; and the relevance, acceptability, and satisfaction of the programme.

Clinical Trial Description

Study Design This study will use a mixed-methods approach to qualitatively and quantitatively address the research aims. It will be implemented from May to July 2021 in the Mpumalanga province of South Africa. The study design will involve a) pre-post quantitative analyses of primary and secondary outcomes for both PLH Teens-Original and PLH Teens-Hybrid, b) difference in analyses to compare effects between the two delivery modalities, and c) qualitative interviews and quantitative analyses of programme feasibility and implementation. Recruitment Recruitment of parents/caregivers and adolescents will be integrated into CHAMP's current recruitment strategy which includes engaging with schools, faith-based organisations, local NGOs, health facilities, United States Agency for International Development (USAID) DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) partners, door-to-door engagement and other contextually relevant approaches. CHAMP leverages its partnerships for recruitment and the CHAMP partner, Grassroots Soccer, actively engages in recruitment for the DREAMS programme. Participants enrolled into the hybrid PLH programme will be screened using the USAID approved Vulnerability Assessment Tool to ensure that the most vulnerable households are reached. The pilot will target caregivers in the Nelspruit area to ensure adequate access to internet connectivity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05071924
Study type	Interventional
Source	University of Oxford
Contact
Status	Completed
Phase	N/A
Start date	July 5, 2021
Completion date	June 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.