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Clinical Trial Summary

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.


Clinical Trial Description

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 overall frequency of alcohol consumption during the referent period (past 3 months); and

- the usual number of drinks consumed on days when the individual reported drinking alcohol.

The network effect on sexual and drug-use behaviors will be measured as follows:

- Data at each of the three time points (baseline, 3 and 6 months) will be evaluated to determine whether sexual and drug-use behaviors within networks are more correlated than such behaviors between networks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00107562
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date February 2005
Completion date March 2006

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