PLH for Teens - Hybrid Delivery

NCT ID: NCT05071924

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2022-06-01

Brief 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.

Detailed 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.

Conditions

Child Maltreatment; Positive Parenting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PLH Teens Original

The original in-person PLH programme is delivered by community-based workers in low-resource settings. Implementation occurs in a group-based format with both joint parent and teen sessions (10 sessions) and separate parent and teen sessions (4 sessions).

Group Type: EXPERIMENTAL

PLH Teens Original: In-person PLH programme for parents and teens by community-based workers

Intervention Type: BEHAVIORAL

This in-person intervention is delivered over 14 sessions (10 joint parent and teen sessions and 4 separate parent and teen sessions).

PLH Teens Hybrid

The hybrid delivery of PLH Teens consists of 8 sessions delivered to parents via WhatsApp (ParentChat-Teens) and 4 sessions delivered to parents and adolescents in person.

Group Type: EXPERIMENTAL

PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators

Intervention Type: BEHAVIORAL

The hybrid intervention delivered over 12 sessions (8 sessions delivered via WhatsApp groups to parents only and 4 sessions delivered in-person to parents and teens together).

Interventions

PLH Teens Original: In-person PLH programme for parents and teens by community-based workers

This in-person intervention is delivered over 14 sessions (10 joint parent and teen sessions and 4 separate parent and teen sessions).

Intervention Type: BEHAVIORAL

PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators

The hybrid intervention delivered over 12 sessions (8 sessions delivered via WhatsApp groups to parents only and 4 sessions delivered in-person to parents and teens together).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Any person over the age of 18 currently caring for a child between the ages of 10 and 17
• Has the ability to attend the in-person parenting support group (PLH Teens-Original)
• Has access to a WhatsApp compatible smartphone and is willing to join an online parenting support group (PLH Teens-Hybrid)
• Has provided consent to participate in the study

• Must be between the age of 10 and 17
• Has a parent or caregiver who is participating in the programme
• Parent has provided consent to participate in the study
• Has provided assent to participate in the study

• The facilitator must be over the age of 18
• Has completed a facilitator training workshop specifically for the PLH-Teens hybrid delivery prior to intervention delivery
• Is able to access the in-person session location
• Has a smart-phone or device capable of delivering the programme via an online platform such as WhatsApp or Viber
• Has provided informed consent to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mothers2Mothers

UNKNOWN

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

DrJamieLachman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamie M. Lachman, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

PLH/M2M/HY21

Identifier Type: -

Identifier Source: org_study_id