Substance Use
Conditions
Keywords
adolescents, primary care, sexual assault, substance use, sexual risk behavior
Brief summary
Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.
Detailed description
Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT after accounting for attrition. Given that the RCT would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would indicate feasibility for a larger RCT.
Interventions
BEHAVIORALIntervention
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.
Sponsors
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Participant and Investigator are blinded to condition
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 14-18 * Recent visit to primary care doctor
Exclusion criteria
* Inability to comprehend English independently due to disability or language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment and Recruitment Rate | within 2 year recruitment period | Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study |
| Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study | within 6 months of baseline participation | Feasibility of retention was assessed by the proportion of participants retained in the study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| Control Assessment only control. | 62 |
| Total | 123 |
Baseline characteristics
| Characteristic | Intervention Group | Control | Total |
|---|---|---|---|
| Age, Continuous | 15.62 years STANDARD_DEVIATION 1.39 | 15.63 years STANDARD_DEVIATION 1.24 | 15.63 years STANDARD_DEVIATION 1.31 |
| Ever engaged in sex | 14 Participants | 13 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 59 Participants | 58 Participants | 117 Participants |
| Race/Ethnicity, Customized Hispanic or Latine | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latine | 46 Participants | 50 Participants | 96 Participants |
| Race/Ethnicity, Customized Not listed or prefer not to answer | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 61 participants | 62 participants | 123 participants |
| Sex/Gender, Customized Boy | 31 Participants | 27 Participants | 58 Participants |
| Sex/Gender, Customized Girl | 28 Participants | 34 Participants | 62 Participants |
| Sex/Gender, Customized Nonbinary | 2 Participants | 1 Participants | 3 Participants |
| Substance use before sex in past 90 days | 1 Participants | 4 Participants | 5 Participants |
| Substance Use Risk Alcohol | 8 Participants | 8 Participants | 16 Participants |
| Substance Use Risk Cannabis | 8 Participants | 12 Participants | 20 Participants |
| Substance Use Risk Illegal drugs | 2 Participants | 1 Participants | 3 Participants |
| Substance Use Risk Prescription drug misuse | 8 Participants | 8 Participants | 16 Participants |
| Substance Use Risk Tobacco or vaping | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 62 |
| other Total, other adverse events | 0 / 61 | 0 / 62 |
| serious Total, serious adverse events | 0 / 61 | 0 / 62 |
Outcome results
Primary
Enrollment and Recruitment Rate
Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study
Time frame: within 2 year recruitment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Enrollment and Recruitment Rate | 61 Participants |
| Control | Enrollment and Recruitment Rate | 62 Participants |
Primary
Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study
Feasibility of retention was assessed by the proportion of participants retained in the study
Time frame: within 6 months of baseline participation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study | 50 Participants |
| Control | Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study | 54 Participants |