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Clinical Trials/NCT03489434
NCT03489434
Completed
Not Applicable

Technology-Based Prevention for Adolescents in Primary Care

Georgia State University1 site in 1 country123 target enrollmentSeptember 28, 2021
ConditionsSubstance Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use
Sponsor
Georgia State University
Enrollment
123
Locations
1
Primary Endpoint
Enrollment and Recruitment Rate
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2021
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda Gilmore

Assistant Professor

Georgia State University

Eligibility Criteria

Inclusion Criteria

  • Aged 14-18
  • Recent visit to primary care doctor

Exclusion Criteria

  • Inability to comprehend English independently due to disability or language

Outcomes

Primary Outcomes

Enrollment and Recruitment Rate

Time Frame: 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

Time Frame: within 6 months of baseline participation

Feasibility of retention was assessed by the proportion of participants retained in the study

Study Sites (1)

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