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

NCT ID: NCT05932056

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

Detailed 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.

Conditions

Violence

Study Design

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

Study Groups

Miles de Manos (Thousands of Hands) Intervention

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.

Group Type: EXPERIMENTAL

Miles de Manos (Thousands of Hands)

Intervention Type: BEHAVIORAL

Miles de Manos (Thousands of Hands) is a school-based group intervention that incorporates elements of evidence-based behavior management interventions in parent, teacher, and parent-teacher joint sessions.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Miles de Manos (Thousands of Hands)

Miles de Manos (Thousands of Hands) is a school-based group intervention that incorporates elements of evidence-based behavior management interventions in parent, teacher, and parent-teacher joint sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Students in grades 3-5, and their parents and teachers, from participating schools located in neighborhoods in and around Tegucigalpa, Honduras.

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

STUDY00000446

Identifier Type: -

Identifier Source: org_study_id