Family Men (English Title) (HOMBRES)
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|ClinicalTrials.gov Identifier: NCT03730987|
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse Domestic Violence HIV/AIDS||Behavioral: HoMBReS intervention Behavioral: Families Talking Together Behavioral: Diabetes Prevention Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: HoMBRES Intervention
Six sessions (2 sessions per week, approximately 2.5 hours each) with the fathers, in which facilitators conduct educational sessions with groups of 6-8 men per group. One of the sessions includes an intervention of families talking together.
Behavioral: HoMBReS intervention
The experimental group (group A) will receive an intervention based on social cognitive theory and empowerment education that aims to reduce risky sexual behaviors among recently migrated rural men.
Other Name: HoMBReS
Behavioral: Families Talking Together
The brief intervention, is a parent-based intervention to teach parents effective strategies proven to reduce adolescent sexual risk behavior. The intervention specifically targets the parent (not the adolescent) to: promote communication skills, build parent-adolescent relationships, develop effective monitoring strategies, and prepare them to teach adolescents assertiveness and substance abuse refusal skills.
Other Name: FTT
Active Comparator: Diabetes Prevention Intervention
Three sessions of 2.5 hours held once per week. Session content will focus on the importance of physical activity, healthy eating, and maintaining a healthy weight.
Behavioral: Diabetes Prevention Intervention
Session content will focus on the importance of physical activity, healthy eating and maintaining a healthy weight.
- Change in quantity of substance use [ Time Frame: Baseline, 6 months ]As measured by the Time-Line Followback questionnaire with participants self-reporting number of drinks per day
- Change in self-reported engagement in risky sexual behaviors [ Time Frame: Baseline, 6 months ]As measured using the PhenX Toolkit Sexual Risk Behavior self-reported instrument utilizing the number of unprotected sexual encounters as well as number of sexual partners
- Change in self-reported experiences of violence [ Time Frame: Baseline, 6 months ]As measured using the PhenX Toolkit Exposures to Violence self-reported instrument
- Change in frequency of substance use [ Time Frame: Baseline, 6 months ]As measured by the Time-Line Followback self-reported questionnaire with participants self-reporting number days drinking
- Change in Level of self-reported communication with son [ Time Frame: Baseline, 6 months ]As measured using the self-reported Parenting Practices Instrument, 12 item Parental Monitoring subscale rated on a 7-item Likert scale. Scores range from 0-72, with higher scores indicating higher levels of parental monitoring.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730987
|Contact: Patria Rojas, PhD||305 firstname.lastname@example.org|
|Contact: Marisabel Canedo, LMSW||305 email@example.com|
|United States, Florida|
|Florida International University||Not yet recruiting|
|Miami, Florida, United States, 33199|
|Contact: Patria Rojas, PhD 305-348-7352 firstname.lastname@example.org|
|Contact: Marisabel Canedo, LMSW 305 348-7583 email@example.com|
|Principal Investigator:||Patria Rojas, Phd||Florida International University|