Clinical trial NCT05932056: A Randomized Controlled Trial of Miles de Manos (Thousands of Hands)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Violence
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.
* 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.

Primary outcomes:
measure: Child conduct problems (baseline)
timeFrame: Child conduct problems are measured at baseline.
measure: Child conduct problems (6-9 months)
timeFrame: Child conduct problems are measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Child conduct problems (12-15 months)
timeFrame: Child conduct problems are measured at about 1 year post-baseline
measure: Change from baseline child conduct problems to 6-9 months
timeFrame: Change in child conduct problems between baseline and 6-9 months.
measure: Change from baseline child conduct problems to about 1 year post-baseline
timeFrame: Change in child conduct problems between baseline and about 1 year post-baseline.
measure: Child hyperactivity/inattention (baseline)
timeFrame: Child hyperactivity/inattention is measured at baseline.
measure: Child hyperactivity/inattention (6-9 months)
timeFrame: Child hyperactivity/inattention is measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Child hyperactivity/inattention (12-15 months)
timeFrame: Child hyperactivity/inattention is measured at about 1 year post-baseline.
measure: Change from baseline child hyperactivity/inattention to 6-9 months
timeFrame: Change in baseline child hyperactivity/inattention to 6-9 months.
measure: Change from baseline child hyperactivity/inattention to about 1 year
timeFrame: Change from baseline child hyperactivity/inattention to about 1 year post-baseline
measure: Child emotional problems (baseline)
timeFrame: Child emotional problems are measured at baseline.
measure: Child emotional problems (6-9 months)
timeFrame: Child emotional problems are measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools..
measure: Child emotional problems (12-15 months)
timeFrame: Child emotional problems are measured at about 1 year post-baseline.
measure: Change in baseline child emotional problems to 6-9 months
timeFrame: Change in baseline child emotional problems to 6-9 months
measure: Change in baseline child emotional problems to about 1 year
timeFrame: Child emotional problems are measured at about 1 year post-baseline.
measure: Child peer relationship problems (baseline)
timeFrame: Child peer relationship problems are measured at baseline.
measure: Child peer relationship problems (6-9 months)
timeFrame: Child peer relationship problems are measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Child peer relationship problems (12-15 months)
timeFrame: Child peer relationship problems are measured at about 1 year post-baseline.
measure: Change in baseline child peer relationship problems to 6-9 months
timeFrame: Change in baseline child peer relationship problems to 6-9 months
measure: Change in baseline child peer relationship problems to about 1 year
timeFrame: Change in baseline child peer relationship problems to about 1 year
measure: Parenting (baseline)
timeFrame: Parenting is measured at baseline.
measure: Parenting (6-9 months)
timeFrame: Parenting is measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Parenting (12-15 months)
timeFrame: Parenting is measured at about 1 year post-baseline.
measure: Change in baseline parenting to 6-9 months.
timeFrame: Change in baseline parenting to 6-9 months.
measure: Change in baseline parenting to about 1 year.
timeFrame: Change in baseline parenting to about 1 year.
measure: Family adjustment (baseline)
timeFrame: Family adjustment is measured at baseline.
measure: Family adjustment (6-9 months)
timeFrame: Family adjustment is 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Family adjustment (12-15 months)
timeFrame: Family adjustment is measured at about 1 year post-baseline.
measure: Change in baseline family adjustment to 6-9 months
timeFrame: Change in baseline family adjustment to 6-9 months
measure: Change in baseline family adjustment to about 1 year
timeFrame: Change in baseline family adjustment to about 1 year
measure: Teacher classroom behavior management (baseline)
timeFrame: Teacher classroom behavior management is measured at baseline.
measure: Teacher classroom behavior management (6-9 months)
timeFrame: Teacher classroom behavior management is measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.
measure: Teacher classroom behavior management (12-15 months)
timeFrame: Teacher classroom behavior management is measured at about 1 year post-baseline.
measure: Change in baseline teacher classroom behavior management to 6-9 months
timeFrame: Change in baseline teacher classroom behavior management to 6-9 months
measure: Change in baseline teacher classroom behavior management to about 1 year
timeFrame: Change in baseline teacher classroom behavior management to about 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References: