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NCT03489434 Clinical Trial

Technology-Based Prevention for Adolescents in Primary Care

Substance Use Clinical Trial

Official title:
Technology-Based Prevention for Adolescents in Primary Care

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03489434
Other study ID # H21524
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date October 3, 2022

Study information
Verified date February 2023
Source Georgia State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date October 3, 2022
Est. primary completion date October 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - Aged 14-18 - Recent visit to primary care doctor Exclusion Criteria: - Inability to comprehend English independently due to disability or language

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Georgia State University Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enrollment and recruitment rate Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study within 2 year recruitment period
Primary Retention Rate Feasibility of retention was assessed by the proportion of participants retained in the study within 6 months of baseline participation
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