ViolenceMdMNCT05932056
A Randomized Controlled Trial of Miles de Manos (Thousands of Hands)
A study testing Miles de Manos (Thousands of Hands) in people with Violence, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 99 years
- Conditions the study is for
- Violence
- What is being tested?
- Miles de Manos (Thousands of Hands)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Schools with prior implementation of Miles de Manos (Thousands of Hands) will not be eligible to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Miles de Manos (Thousands of Hands)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miles de Manos (Thousands of Hands)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in baseline teacher classroom behavior management to about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932056
- Sponsor's protocol ID
- STUDY00000446
- Acronym
- MdM
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make personally deidentified data sets available to other researchers that include individual data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05932056
- Acronym / sponsor ID
- MdM / STUDY00000446
- Conditions
- Violence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miles de Manos (Thousands of Hands) Intervention | Experimental | Behavioral: Miles de Manos (Thousands of Hands)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. |
| Control | No intervention | –Parents and teachers from schools randomized to this arm will receive services as usual as provided by their schools. |
Who may qualify
- Ages
- 7 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Schools with prior implementation of Miles de Manos (Thousands of Hands) will not be eligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Miles de Manos (Thousands of Hands) Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: Yes. We will make personally deidentified data sets available to other researchers that include individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miles de Manos (Thousands of Hands) in people with Violence, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child conduct problems (baseline) (time frame: Child conduct problems are measured at baseline.). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.