Trial Outcomes & Findings for Technology-Based Prevention for Adolescents in Primary Care (NCT NCT03489434)
NCT ID: NCT03489434
Last Updated: 2025-02-14
Results Overview
Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
within 2 year recruitment period
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Intervention Group
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Intervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
|
Control
Assessment only control.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
55
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Technology-Based Prevention for Adolescents in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention Group
n=61 Participants
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Intervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
|
Control
n=62 Participants
Assessment only control.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.62 years
STANDARD_DEVIATION 1.39 • n=5 Participants
|
15.63 years
STANDARD_DEVIATION 1.24 • n=7 Participants
|
15.63 years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
Sex/Gender, Customized
Boy
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Girl
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Nonbinary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not listed or prefer not to answer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latine
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latine
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
62 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
Substance Use Risk
Alcohol
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Substance Use Risk
Cannabis
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Substance Use Risk
Tobacco or vaping
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Substance Use Risk
Prescription drug misuse
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Substance Use Risk
Illegal drugs
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ever engaged in sex
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Substance use before sex in past 90 days
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 2 year recruitment periodFeasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study
Outcome measures
| Measure |
Intervention Group
n=61 Participants
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Intervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
|
Control
n=62 Participants
Assessment only control.
|
|---|---|---|
|
Enrollment and Recruitment Rate
|
61 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: within 6 months of baseline participationFeasibility of retention was assessed by the proportion of participants retained in the study
Outcome measures
| Measure |
Intervention Group
n=61 Participants
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Intervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
|
Control
n=62 Participants
Assessment only control.
|
|---|---|---|
|
Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study
|
50 Participants
|
54 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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