Trial Outcomes & Findings for Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents (NCT NCT01170260)
NCT ID: NCT01170260
Last Updated: 2024-04-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
460 participants
Primary outcome timeframe
1 year
Results posted on
2024-04-23
Participant Flow
Participant milestones
| Measure |
Randomized to Alcohol Content
Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments).
|
Sex Plus Alcohol Risk Reduction
Corresponding intervention gives info focusing on sex and alcohol risk reduction only
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio
|
Sexual + Alcohol + Cannabis Content
Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
|
|---|---|---|---|
|
Overall Study
STARTED
|
143
|
155
|
162
|
|
Overall Study
COMPLETED
|
143
|
155
|
162
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
Baseline characteristics by cohort
| Measure |
Info-only Sexual Risk Reduction
n=143 Participants
Corresponding intervention gives information only on STDs/HIV
INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY): Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
|
Sex Plus Alcohol Risk Reduction
n=155 Participants
Corresponding intervention gives info focusing on sex and alcohol risk reduction only
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion
|
Sex + Alcohol + Marijuana Risk Reduction
n=162 Participants
Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
|
Total
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.85 years
n=5 Participants
|
15.82 years
n=7 Participants
|
15.78 years
n=5 Participants
|
15.81 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
143 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Randomized to Alcohol Content
n=143 Participants
Each intervention had identical structure and length (2 hours for intervention, 1 hour for assessments).
|
Sex Plus Alcohol Risk Reduction
n=155 Participants
Corresponding intervention gives info focusing on sex and alcohol risk reduction only
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH): Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussio
|
Sexual + Alcohol + Cannabis Content
n=162 Participants
Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION: Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
|
|---|---|---|---|
|
Number of Participants With Risky Sexual Behavior Measured for 1 Year
|
143 Participants
|
155 Participants
|
162 Participants
|
Adverse Events
Randomized to Alcohol Content
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sex Plus Alcohol Risk Reduction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Sexual + Alcohol + Cannabis Content
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place