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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

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