A Randomized Controlled Trial of Miles de Manos (Thousands of Hands) (MdM)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Violence

Treatments: Behavioral: Miles de Manos (Thousands of Hands)

Study type: Interventional

Funder types: Other

Identifiers

NCT05932056

STUDY00000446

Details and patient eligibility

About

Violence is one of the leading causes of death for young people and has widespread costs for individuals, families and communities. This study will test the effectiveness of Miles de Manos (Thousands of Hands), a group-based violence prevention program for elementary school students in Honduras. Miles de Manos (Thousands of Hands) has three components: parents/caregiver groups, teacher groups, and groups that combine parents/caregivers and teachers together. The study will examine the program's impact on parent and teacher's behaviors as well as student behavior problems.

Full description

The purpose of this study, a randomized controlled trial, is to examine the outcomes, and potential mediators and moderators of those outcomes, related to a school-based youth violence program, Miles de Manos (Thousands of Hands; MdM), delivered within public primary schools within the country of Honduras. Miles de Manos (Thousands of Hands), which is conducted with parents/caregivers and teachers, was developed through a collaboration of a multinational group of practitioners, educators, administrators, scientists, and curriculum writers from Honduras, El Salvador, Guatemala, Nicaragua, Germany, and the United States with funding from the German non-governmental organization Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ). It is similar in core content to evidence-based programs that were developed in the United States. During the development process, the program was piloted tested in Honduras multiple times, and is currently being employed in public primary schools across Honduras. The aims of the study are as follows:

Aim 1. To examine the effectiveness of a culturally specified youth violence prevention program on improving effective parent and teacher behavior management practices and reducing both youth problem behaviors and youth association with peers and adults involved in problem behaviors.

Aim 2. To investigate potential mediators of any outcomes due to the intervention, and specifically to conduct a test of the social learning theory underlying the intervention.

Aim 3. To investigate potential moderators of any outcomes due to the intervention.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 7 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Students in grades 3-5, and their parents and teachers, from participating schools located in neighborhoods in and around Tegucigalpa, Honduras.
• Inclusion criteria for participating schools will include those with no prior implementation of Miles de Manos (Thousands of Hands); school location will be in urban or semi-urban areas; and adequate school engagement and commitment from staff and school leaders, parents, community leaders, and community institutions and officials.

Exclusion criteria

• Schools with prior implementation of Miles de Manos (Thousands of Hands) will not be eligible to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

Miles de Manos (Thousands of Hands) Intervention

Experimental group

Description:

Parents and teachers from schools randomized to this arm will receive the Miles de Manos (Thousands of Hands) intervention. Miles de Manos (Thousands of Hands) comprises 3 components: a cognitive-behavioral skills training component for parents (8 sessions), a cognitive-behavioral skills training component for school staff (10 sessions), and a "bridge" component that brings parents, teachers, and school administrators together to talk about how to support each other's efforts related to youth violence prevention (4 sessions). Core elements include effective communication, clear expectations, limits and consequences, positive reinforcement, adult supervision and monitoring, effective problem solving, and emotion regulation. Miles de Manos (Thousands of Hands) is highly interactive and involves brief lectures, small and large group discussions, role-plays, and interactive exercises.

Treatment:

Behavioral: Miles de Manos (Thousands of Hands)

Control

No Intervention group

Description:

Parents and teachers from schools randomized to this arm will receive services as usual as provided by their schools.