Substance UsePhase 2NCT01257022
Familias Unidas: Preventing Drug Abuse and HIV in Hispanic First Offenders
A Phase 2 study testing Familias Unidas in people with Substance Use and Unsafe Sexual Behavior, run by University of Miami at 1 site in United States.
Trial summary
The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United Families), a family-based, ecodevelopmental intervention found to be previously efficacious in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in non-delinquent Hispanic adolescents… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Unsafe Sexual Behavior
- What is being tested?
- Familias Unidas
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Apr 2011
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas
- First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism.
- Adolescents between 12 and 17 years of age
- Adolescents living with an adult primary caregiver who is willing to participate
Who cannot join
- Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family Studies and Miami-Dade County
Miami, Florida, 33136
About this study
Official title: Preventing Drug Abuse and HIV in Hispanic First Offenders
The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United Families), a family-based, ecodevelopmental intervention found to be previously efficacious in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al., 2007).
The study hypotheses are as follows:
Read more
Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing drug use among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by improvements in family functioning.
Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially mediated by improvements in family functioning.
Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing subsequent criminal offenses among Hispanic first offending adolescents or in preventing a first time offense for those at risk for committing a first time offense over time.
Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated by family functioning.
Read the detailed description
Familias Unidas aims to prevent drug use and unprotected sexual behavior by increasing family functioning. A sample of 240 Hispanic adolescent first offenders or those at risk of becoming first offenders (age range 12 to 17) and 240 primary caregivers will be randomized to one of two conditions: Familias Unidas or Treatment as Usual. The investigators do not expect any risks to participants for participating in this study; however, participants may feel embarrassed by some of the content or feel fatigued as a result of completing the assessments. Also, depending on which group participants are assigned to, they may be less likely to use drugs and practice unsafe sexual behaviors and more likely to function better as families.
The proposed study will be guided by four aims. AIM 1 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing illicit drug use in a sample of Hispanic youth first offenders or those at high risk of committing a first offense; AIM 2 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing unsafe sexual behavior; AIM 3 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing a first offense or reducing the number of subsequent criminal offenses ; and AIM 4 is to assess the extent to which family functioning mediates the effects of the intervention on illicit drug use, unsafe sexual behavior, and first or subsequent criminal offenses.
Compared to non-Hispanic whites, Hispanic adolescents are highly vulnerable to drug use and HIV infection. Hispanic adolescents between the ages of 13 to 19 are five times more likely to be infected with HIV than are same-aged non-Hispanic Whites (CDC-P, 2006). Compared to non-Hispanic whites and to African Americans, Hispanic 8th graders report the highest lifetime, annual, and 30-day prevalence rates of alcohol, cigarette, and licit or illicit drug use (with the exception of amphetamines; Johnston et al., 2008). Hispanic adolescents also have higher rates of unprotected sex at last intercourse (CDC-P, 2007) than non-Hispanic whites or African Americans. Drug use and unsafe sexual behavior are risks for HIV infection. Hispanics are also a youthful population, with more than one-third under the age of 18 (Marotta \& Garcia, 2003). Preventing drug use and HIV in Hispanics, and particularly among Hispanic youth at elevated risk for drug use and unsafe sexual behavior, such as Hispanics in the criminal justice setting or those at risk of entering the criminal justice system (Telpin, 2003), is therefore of vital importance.
- Conditions
- Substance Use, Unsafe Sexual Behavior
- Being tested
- Familias Unidas
- Keywords
- Prevention, HIV, Substance use, Hispanic, Adolescents, Unsafe sexual behavior, Behavioral intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familias UnidasBehavioural
There will be 8 group sessions and 4 family visits. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents. During family visits, facilitators assist families in practicing skills and restructuring family interactions. The parent group sessions focus on parental investment in the adolescent's worlds (e.g., peer and school worlds), family communication, family support, behavior management/positive parenting, parental monitoring, adolescent substance use, and adolescent unsafe sex and HIV.
| Study group | Role | What they receive |
|---|---|---|
| Family Function Intervention | Experimental | Familias Unidas Intervention Program Receives: Behavioral: Familias Unidas |
| Treatment as Usual | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Substance use as measured by items similar to those in the Monitoring the Future Survey.
Measured: 1 year
Unsafe sexual behavior
Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.
Measured: 1 year
Secondary outcomes (1)
Family functioning
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Prado, University of Miami
- Investigators
- Guillermo Prado, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257022
- Sponsor's protocol ID
- 1R01DA025894-01
- Status last verified
- Mar 2014
- First submitted
- 8 Dec 2010
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prado G, Pantin H, Huang S, Cordova D, Tapia MI, Velazquez MR, Calfee M, Malcolm S, Arzon M, Villamar J, Jimenez GL, Cano N, Brown CH, Estrada Y. Effects of a family intervention in reducing HIV risk behaviors among high-risk Hispanic adolescents: a randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Feb;166(2):127-33. doi: 10.1001/archpediatrics.2011.189. Epub 2011 Oct 3.
PubMed 21969363
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Drug Abuse and HIV in Hispanic First Offenders
- ClinicalTrials.gov ID
- NCT01257022
- Acronym / sponsor ID
- 1R01DA025894-01
- Conditions
- Substance Use, Unsafe Sexual Behavior
- Keywords
- Prevention, HIV, Substance use, Hispanic, Adolescents, Unsafe sexual behavior, Behavioral intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Dec 2010 (estimated)
- 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.
The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United Families), a family-based, ecodevelopmental intervention found to be previously efficacious in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al., 2007).
The study hypotheses are as follows:
Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing drug use among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by improvements in family functioning.
Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially mediated by improvements in family functioning.
Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing subsequent criminal offenses among Hispanic first offending adolescents or in preventing a first time offense for those at risk for committing a first time offense over time.
Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated by family functioning.
Detailed description
Familias Unidas aims to prevent drug use and unprotected sexual behavior by increasing family functioning. A sample of 240 Hispanic adolescent first offenders or those at risk of becoming first offenders (age range 12 to 17) and 240 primary caregivers will be randomized to one of two conditions: Familias Unidas or Treatment as Usual. The investigators do not expect any risks to participants for participating in this study; however, participants may feel embarrassed by some of the content or feel fatigued as a result of completing the assessments. Also, depending on which group participants are assigned to, they may be less likely to use drugs and practice unsafe sexual behaviors and more likely to function better as families.
The proposed study will be guided by four aims. AIM 1 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing illicit drug use in a sample of Hispanic youth first offenders or those at high risk of committing a first offense; AIM 2 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing unsafe sexual behavior; AIM 3 is to evaluate the efficacy of Familias Unidas, relative to Treatment as Usual in preventing a first offense or reducing the number of subsequent criminal offenses ; and AIM 4 is to assess the extent to which family functioning mediates the effects of the intervention on illicit drug use, unsafe sexual behavior, and first or subsequent criminal offenses.
Compared to non-Hispanic whites, Hispanic adolescents are highly vulnerable to drug use and HIV infection. Hispanic adolescents between the ages of 13 to 19 are five times more likely to be infected with HIV than are same-aged non-Hispanic Whites (CDC-P, 2006). Compared to non-Hispanic whites and to African Americans, Hispanic 8th graders report the highest lifetime, annual, and 30-day prevalence rates of alcohol, cigarette, and licit or illicit drug use (with the exception of amphetamines; Johnston et al., 2008). Hispanic adolescents also have higher rates of unprotected sex at last intercourse (CDC-P, 2007) than non-Hispanic whites or African Americans. Drug use and unsafe sexual behavior are risks for HIV infection. Hispanics are also a youthful population, with more than one-third under the age of 18 (Marotta \& Garcia, 2003). Preventing drug use and HIV in Hispanics, and particularly among Hispanic youth at elevated risk for drug use and unsafe sexual behavior, such as Hispanics in the criminal justice setting or those at risk of entering the criminal justice system (Telpin, 2003), is therefore of vital importance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Function Intervention | Experimental | Behavioral: Familias UnidasFamilias Unidas Intervention Program |
| Treatment as Usual | No intervention | –Control |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Female and male adolescents of Hispanic immigrant origin, defined by at least one parent born in a Spanish-speaking country of the Americas
- First-time offenders or Hispanic adolescents, identified by Miami Dade County Public Schools as exhibiting Level III behaviors which include: assault/threat against a non-staff member, breaking and entering/burglary, fighting (serious), hazing, possession or use of alcohol and/or controlled substances, possession of simulated weapons, trespassing, and vandalism.
- Adolescents between 12 and 17 years of age
- Adolescents living with an adult primary caregiver who is willing to participate
Key exclusion criteria (1 listed)
- Family reports to have (tentative or firm) plans to move out of the South Florida area during the year of the study
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 |
|---|---|---|
| Familias UnidasThere will be 8 group sessions and 4 family visits. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents. During family visits, facilitators assist families in practicing skills and restructuring family interactions. The parent group sessions focus on parental investment in the adolescent's worlds (e.g., peer and school worlds), family communication, family support, behavior management/positive parenting, parental monitoring, adolescent substance use, and adolescent unsafe sex and HIV. | Behavioural | Family Function Intervention |
Primary outcome
Substance use
Time frame: 1 year
Substance use as measured by items similar to those in the Monitoring the Future Survey.
Unsafe sexual behavior
Time frame: 1 year
Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs.
1 secondary outcome
Family functioning
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Derived from this study: PubMed 21969363Prado G, Pantin H, Huang S, Cordova D, Tapia MI, Velazquez MR, Calfee M, Malcolm S, Arzon M, Villamar J, Jimenez GL, Cano N, Brown CH, Estrada Y. Effects of a family intervention in reducing HIV risk behaviors among high-risk Hispanic adolescents: a randomized controlled trial. Arch Pediatr Adolesc Med. 2012 Feb;166(2):127-33. doi: 10.1001/archpediatrics.2011.189. Epub 2011 Oct 3.
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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.
Guillermo Prado, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Familias Unidas in people with Substance Use and Unsafe Sexual Behavior, run by University of Miami 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 4 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: finished, as of the sponsor's last update on 5 Mar 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Substance use (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257022, which also lists 1 linked publication.
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 5 Mar 2014.