NCT03489434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
3.5 years until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

March 29, 2018

Results QC Date

August 1, 2024

Last Update Submit

January 30, 2025

Conditions

Keywords

adolescentsprimary caresexual assaultsubstance usesexual risk behavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study

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

    within 6 months of baseline participation

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control

NO INTERVENTION

Assessment only control.

Interventions

InterventionBEHAVIORAL

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 Group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inability to comprehend English independently due to disability or language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Amanda Gilmore
Organization
Georgia State University

Study Officials

  • Amanda K Gilmore, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participant and Investigator are blinded to condition
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

September 28, 2021

Primary Completion

October 3, 2022

Study Completion

December 31, 2023

Last Updated

February 14, 2025

Results First Posted

February 14, 2025

Record last verified: 2025-01

Locations