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

NCT05932056 | Active Not Recruiting

• 1 other identifier: STUDY00000446
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence

Outcome Measures

Primary Outcomes (35)

• Child conduct problems (baseline)

  Child conduct problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child conduct problems are measured at baseline.

• Child conduct problems (6-9 months)

  Child conduct problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  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.

• Child conduct problems (12-15 months)

  Child conduct problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child conduct problems are measured at about 1 year post-baseline

• Change from baseline child conduct problems to 6-9 months

  Child conduct problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in child conduct problems between baseline and 6-9 months.

• Change from baseline child conduct problems to about 1 year post-baseline

  Child conduct problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in child conduct problems between baseline and about 1 year post-baseline.

• Child hyperactivity/inattention (baseline)

  Child hyperactivity/inattention is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child hyperactivity/inattention is measured at baseline.

• Child hyperactivity/inattention (6-9 months)

  Child hyperactivity/inattention is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  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.

• Child hyperactivity/inattention (12-15 months)

  Child hyperactivity/inattention is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child hyperactivity/inattention is measured at about 1 year post-baseline.

• Change from baseline child hyperactivity/inattention to 6-9 months

  Child hyperactivity/inattention is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in baseline child hyperactivity/inattention to 6-9 months.

• Change from baseline child hyperactivity/inattention to about 1 year

  Child hyperactivity/inattention is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change from baseline child hyperactivity/inattention to about 1 year post-baseline

• Child emotional problems (baseline)

  Child emotional problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child emotional problems are measured at baseline.

• Child emotional problems (6-9 months)

  Child emotional problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  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..

• Child emotional problems (12-15 months)

  Child emotional problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child emotional problems are measured at about 1 year post-baseline.

• Change in baseline child emotional problems to 6-9 months

  Child emotional problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in baseline child emotional problems to 6-9 months

• Change in baseline child emotional problems to about 1 year

  Child emotional problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child emotional problems are measured at about 1 year post-baseline.

• Child peer relationship problems (baseline)

  Child peer relationship problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child peer relationship problems are measured at baseline.

• Child peer relationship problems (6-9 months)

  Child peer relationship problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  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.

• Child peer relationship problems (12-15 months)

  Child peer relationship problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Child peer relationship problems are measured at about 1 year post-baseline.

• Change in baseline child peer relationship problems to 6-9 months

  Child peer relationship problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in baseline child peer relationship problems to 6-9 months

• Change in baseline child peer relationship problems to about 1 year

  Child peer relationship problems is a sub-scale of the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire about 2-17 year olds. The SDQ response scale consists of 3 choices: 0-not true; 1-somewhat true; 2-certainly true. The sub-scale for conduct problems includes the mean score of 5 items.

  Change in baseline child peer relationship problems to about 1 year

• Parenting (baseline)

  The parenting outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parenting practices in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 4 sub-scales totaling 21 items that focus on: parental consistency, coercive parenting, positive encouragement, and parent-child relationship.

  Parenting is measured at baseline.

• Parenting (6-9 months)

  The parenting outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parenting practices in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 4 sub-scales totaling 21 items that focus on: parental consistency, coercive parenting, positive encouragement, and parent-child relationship.

  Parenting is measured at 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.

• Parenting (12-15 months)

  The parenting outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parenting practices in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 4 sub-scales totaling 21 items that focus on: parental consistency, coercive parenting, positive encouragement, and parent-child relationship.

  Parenting is measured at about 1 year post-baseline.

• Change in baseline parenting to 6-9 months.

  The parenting outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parenting practices in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 4 sub-scales totaling 21 items that focus on: parental consistency, coercive parenting, positive encouragement, and parent-child relationship.

  Change in baseline parenting to 6-9 months.

• Change in baseline parenting to about 1 year.

  The parenting outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parenting practices in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 4 sub-scales totaling 21 items that focus on: parental consistency, coercive parenting, positive encouragement, and parent-child relationship.

  Change in baseline parenting to about 1 year.

• Family adjustment (baseline)

  The family adjustment outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parental adjustment in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 3 sub-scales totaling 9 items that focus on: parental adjustment, family relationships, and parental teamwork.

  Family adjustment is measured at baseline.

• Family adjustment (6-9 months)

  The family adjustment outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parental adjustment in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 3 sub-scales totaling 9 items that focus on: parental adjustment, family relationships, and parental teamwork.

  Family adjustment is 6-9 months post-baseline after the termination of the Miles de Manos (Thousands of Hands) program in intervention schools.

• Family adjustment (12-15 months)

  The family adjustment outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parental adjustment in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 3 sub-scales totaling 9 items that focus on: parental adjustment, family relationships, and parental teamwork.

  Family adjustment is measured at about 1 year post-baseline.

• Change in baseline family adjustment to 6-9 months

  The family adjustment outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parental adjustment in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 3 sub-scales totaling 9 items that focus on: parental adjustment, family relationships, and parental teamwork.

  Change in baseline family adjustment to 6-9 months

• Change in baseline family adjustment to about 1 year

  The family adjustment outcome is a sub-scale of the Parent and Family Adjustment Scales (PAFAS). The PAFAS was designed as a brief outcome measure for assessing changes in parental adjustment in the evaluation of group parenting interventions. The inventory consists of the Parenting scale measuring parenting practices and quality of parent-child relationship and of the Family Adjustment scale measuring parental emotional adjustment and partner and family support in parenting. All items are scored from 0 to 3 with the parenting sub-scale reflecting a sum score of 3 sub-scales totaling 9 items that focus on: parental adjustment, family relationships, and parental teamwork.

  Change in baseline family adjustment to about 1 year

• Teacher classroom behavior management (baseline)

  This outcome is measured using the Positive Behavior Intervention and Supports (PBIS) Positive Behavior Support Classroom Management: Self-Assessment Revised. This brief 10-item survey is focused on teacher classroom strategies to support the prosocial behaviors and high academic and social engagement of their students.

  Teacher classroom behavior management is measured at baseline.

• Teacher classroom behavior management (6-9 months)

  This outcome is measured using the Positive Behavior Intervention and Supports (PBIS) Positive Behavior Support Classroom Management: Self-Assessment Revised. This brief 10-item survey is focused on teacher classroom strategies to support the prosocial behaviors and high academic and social engagement of their students.

  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.

• Teacher classroom behavior management (12-15 months)

  This outcome is measured using the Positive Behavior Intervention and Supports (PBIS) Positive Behavior Support Classroom Management: Self-Assessment Revised. This brief 10-item survey is focused on teacher classroom strategies to support the prosocial behaviors and high academic and social engagement of their students.

  Teacher classroom behavior management is measured at about 1 year post-baseline.

• Change in baseline teacher classroom behavior management to 6-9 months

  This outcome is measured using the Positive Behavior Intervention and Supports (PBIS) Positive Behavior Support Classroom Management: Self-Assessment Revised. This brief 10-item survey is focused on teacher classroom strategies to support the prosocial behaviors and high academic and social engagement of their students.

  Change in baseline teacher classroom behavior management to 6-9 months

• Change in baseline teacher classroom behavior management to about 1 year

  This outcome is measured using the Positive Behavior Intervention and Supports (PBIS) Positive Behavior Support Classroom Management: Self-Assessment Revised. This brief 10-item survey is focused on teacher classroom strategies to support the prosocial behaviors and high academic and social engagement of their students.

  Change in baseline teacher classroom behavior management to about 1 year

Study Arms (2)

Miles de Manos (Thousands of Hands) Intervention

EXPERIMENTAL

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.

Behavioral: Miles de Manos (Thousands of Hands)

Control

NO INTERVENTION

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

Interventions

Miles de Manos (Thousands of Hands) 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.

Miles de Manos (Thousands of Hands) Intervention

Eligibility Criteria

• Age: 7 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 6, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After 7/31/2024 when we complete analyses for our primary endpoint.
• Access Criteria: Data will be provided upon request.

Locations

US (1)