Technology-Based Prevention for Adolescents in Primary Care

February 22, 2023 updated by: Amanda Gilmore, Georgia State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to comprehend English independently due to disability or language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Control
Assessment only control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 2 year recruitment period
Retention Rate
Time Frame: within 6 months of baseline participation
Feasibility of retention was assessed by the proportion of participants retained in the study
within 6 months of baseline participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

October 3, 2022

Study Completion (Actual)

October 3, 2022

Study Registration Dates

First Submitted

March 29, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H21524

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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