Technology-Based Prevention for Adolescents in Primary Care

NCT ID: NCT03489434

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-12-31

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

Control

Assessment only control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Amanda Gilmore

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda K Gilmore, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Georgia State University

Atlanta, Georgia, United States

Countries

United States

References

Gilmore AK, Fortson K, Mullican KN, Garcia-Ramirez G, Hutchins A, Bartlett AM, Gooding HC, Wallis E, Levy S, Ruggiero KJ, Kaysen D, Danielson CK, Platner R, Hartman A, Self-Brown S. An eHealth Prevention Program for Substance Use, Sexual Assault, and Sexual Risk Behaviors for Adolescents in Primary Care: Pilot Feasibility Randomized Controlled Trial of Teen Well Check. JMIR Form Res. 2023 Nov 2;7:e50833. doi: 10.2196/50833.

Reference Type: DERIVED

PMID: 37917146 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

H21524

Identifier Type: -

Identifier Source: org_study_id