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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Social networks are thought to hold the potential for shaping behavior on the grounds that social and situational factors more strongly influence behavior than do personality variables. This is a behavioral intervention study that will test a 6-session, small-group, peer-network intervention among adolescent males and females and their friends. The intervention primarily focuses on reducing risky sexual behavior and increasing condom use among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana during sex is also a focus as these two substances are widely used among adolescents and fuel risky sexual behavior.
The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks.
A one-arm intervention design with pre-test assessment within one month before the first intervention session, and with post-test assessments at three and six months following intervention completion will be used. The intervention will be delivered to cohorts of friendship groups comprised of an index friend and their social network. To ensure that baseline data reflect recent, pre-intervention behavior, index participants and their networks will be recruited in small 'cohorts' of 8-16 (average 12) adolescents at a time. These cohorts will then receive the group intervention at the same time. Each cohort of interested and eligible participants (index + network members) will be screened and consented, and will provide baseline data. The first intervention session must occur within one month of baseline data collection. A successive series of these small cohorts will be identified, enrolled and dispatched to receive the intervention with subsequent follow up timelines determined by the date of the final group session of each cohort.
Preliminary effectiveness of the behavioral intervention will be measured as follows:
The primary outcome related to sexual behavior is the self-reported number of unprotected (not protected with male or female condom) vaginal, oral and anal sex acts among all (index and network members) who receive the intervention.
Sexual acts when drunk or high will be measured by counting the number of sexual encounters that occurred concurrently with a respondent reporting being "drunk" or "high".
Alcohol use will be measured by calculating the mean number of drinks consumed. Data will be collected on:
The network effect on sexual and drug-use behaviors will be measured as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The cohort will be comprised of up to 4 index participants and from 1-4 of their network members for a possible range of 8-16 subjects in each cohort (average of 12 per cohort). The vast majority of the intervention will be delivered to both females and males together, but it would be beneficial, and appropriate for this adolescent population, to deliver certain exercises with the two genders separated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adolescent Safer Sex Social Network Intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Test the feasibility, acceptability and preliminary effectiveness intervention | The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks. The ultimate goal is to test the intervention in a randomized, attention-controlled, Phase III trial. | 6 Months |
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Inclusion Criteria:
Index Participant Inclusion Criteria
Self-identifies as all or part "Latino"
Age is between 16 years and 0 days and 19 years and 364 days at the time of study enrollment
In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner
In the past 3 months, reports any of the following:
Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English
Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates)
Network Participant Inclusion Criteria
Age is between 16 years and 0 days to 19 years and 364 days at the time of study enrollment
In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner
Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English
Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates)
Must be reported by an index as a friend who:
Exclusion Criteria:
Index Participant Exclusion Criteria
Network Participant Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mary Latka, PhD | New York Academy of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida College of Medicine | Tampa | Florida | 33606 | United States | ||
| Children's Hospital of Boston |
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| Label | URL |
|---|---|
| description of the Adolescent Trials Network and contact information | View source |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D000428 | Alcohol Drinking |
| D008385 | Marijuana Smoking |
| D012309 | Risk-Taking |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D000074609 | Marijuana Use |
| D000073847 | Smoking, Non-Tobacco Products |
| D012907 | Smoking |
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| Boston |
| Massachusetts |
| 02115 |
| United States |