Viewing Study NCT05932056


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Study NCT ID: NCT05932056
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-27
First Post: 2023-06-15
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Randomized Controlled Trial of Miles de Manos (Thousands of Hands)
Sponsor: University of Texas at Austin
Organization:

Study Overview

Official Title: Miles de Manos (Thousands of Hands): Testing the Efficacy of a School-Based Youth Violence Preventive Intervention in a High Risk International Context
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MdM
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: