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NCT Number: NCT05932056

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Violence

Age range

7 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Child conduct problems (baseline)

    Time frame: Child conduct problems are measured at 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.

  2. Child conduct problems (6-9 months)

    Time frame: 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 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.

  3. Child conduct problems (12-15 months)

    Time frame: Child conduct problems are measured at 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.

  4. Change from baseline child conduct problems to 6-9 months

    Time frame: Change in child conduct problems between baseline and 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.

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

    Time frame: Change in child conduct problems between baseline and 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.

  6. Child hyperactivity/inattention (baseline)

    Time frame: Child hyperactivity/inattention is measured at 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.

  7. Child hyperactivity/inattention (6-9 months)

    Time frame: 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 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.

  8. Child hyperactivity/inattention (12-15 months)

    Time frame: Child hyperactivity/inattention is measured at about 1 year post-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.

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

    Time frame: Change in 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.

  10. Change from baseline child hyperactivity/inattention to about 1 year

    Time frame: Change from baseline child hyperactivity/inattention to about 1 year post-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.

  11. Child emotional problems (baseline)

    Time frame: Child emotional problems are measured at 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.

  12. Child emotional problems (6-9 months)

    Time frame: 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 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.

  13. Child emotional problems (12-15 months)

    Time frame: Child emotional problems are measured at about 1 year post-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.

  14. Change in baseline child emotional problems to 6-9 months

    Time frame: 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.

  15. Change in baseline child emotional problems to about 1 year

    Time frame: Child emotional problems are measured at about 1 year post-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.

  16. Child peer relationship problems (baseline)

    Time frame: Child peer relationship problems are measured at 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.

  17. Child peer relationship problems (6-9 months)

    Time frame: 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 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.

  18. Child peer relationship problems (12-15 months)

    Time frame: Child peer relationship problems are measured at about 1 year post-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.

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

    Time frame: 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.

  20. Change in baseline child peer relationship problems to about 1 year

    Time frame: 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.

  21. Parenting (baseline)

    Time frame: Parenting is measured at 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.

  22. Parenting (6-9 months)

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

    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.

  23. Parenting (12-15 months)

    Time frame: Parenting is measured at about 1 year post-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.

  24. Change in baseline parenting to 6-9 months.

    Time frame: 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.

  25. Change in baseline parenting to about 1 year.

    Time frame: 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.

  26. Family adjustment (baseline)

    Time frame: Family adjustment is measured at 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.

  27. Family adjustment (6-9 months)

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

    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.

  28. Family adjustment (12-15 months)

    Time frame: Family adjustment is measured at about 1 year post-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.

  29. Change in baseline family adjustment to 6-9 months

    Time frame: 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.

  30. Change in baseline family adjustment to about 1 year

    Time frame: 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.

  31. Teacher classroom behavior management (baseline)

    Time frame: Teacher classroom behavior management is measured at 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.

  32. Teacher classroom behavior management (6-9 months)

    Time frame: 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.

    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.

  33. Teacher classroom behavior management (12-15 months)

    Time frame: Teacher classroom behavior management is measured at about 1 year post-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.

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

    Time frame: 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.

  35. Change in baseline teacher classroom behavior management to about 1 year

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

Miles de Manos (Thousands of Hands): Testing the Efficacy of a School-Based Youth Violence Preventive Intervention in a High Risk International Context

Acronym: MdM

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 6, 2023
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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