Saferteens in Primary Care

NCT ID: NCT03410238

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2019-11-15

Brief Summary

The SafERteens Study demonstrated the efficacy of a brief intervention (BI) for violence on changing attitudes, self-efficacy, and reducing violent behaviors, peer victimization, and violence-related consequences among adolescents in the emergency department (ED). Using a RE-AIM framework to measure outcomes (Reach, Effectiveness, Adoption, Implementation, and Maintenance), a study was conducted to translate this BI for violence into clinical practice in the ED. A SafERteens Implementation Package was created, which is housed on a website (www.saferteens.org), and includes: 1) a self-administered screen via iPad; 2) training materials (e.g., standardized patient videos); 3) clinician tools to guide intervention delivery; and 4) a tailored text message booster program.

To increase reach and impact on reducing youth violence, this project will implement SafERteens into primary care. Primary care represents a logical dissemination channel for the SafERteens intervention because 95% of adolescents report having a usual place for primary health care, with 75% receiving medical care in the past six months. Violence interventions have yet to be systematically implemented in primary care settings despite the alarming prevalence of violent behaviors among adolescents.

Detailed Description

This pilot study will customize the SafERteens intervention for the unique constraints of primary care settings and test implementation of the Saferteens brief intervention in primary care using the RE-AIM framework: reach (e.g., number of patients screened and given BI); effectiveness (e.g., change in violent behaviors, peer victimization, and violence-related consequences among intervention and control groups); adoption (e.g., number of providers trained, hours participated in training); implementation (e.g., participant ratings of intervention); and maintenance (e.g., ongoing screening and interventions during maintenance phase). Specifically, a control sample of youth ages 14-18 will be obtained, who will complete a baseline and 3-month follow-up survey, but who will not receive the intervention, and an intervention sample of youth ages 14-18 will be obtained, who will receive the Saferteens BI and will complete a baseline and 3-month follow-up survey. These data will provide a control sample for testing effectiveness of the Saferteens intervention package, versus the intervention sample.

Conditions

Violence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Treatment

Participants receive Saferteens Brief Intervention and a brochure containing psycho-education and resources.

Group Type: EXPERIMENTAL

Saferteens Brief Intervention

Intervention Type: BEHAVIORAL

A 30 minute private one-on-one brief motivational interviewing intervention administered by clinic staff. The goal of the intervention is to reduce and prevent youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on-one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior. In the 2 months following the intervention, participants will receive booster text messages tailored to their responses during the intervention.

Control

Participants receive a brochure containing psycho-education and resources only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Saferteens Brief Intervention

A 30 minute private one-on-one brief motivational interviewing intervention administered by clinic staff. The goal of the intervention is to reduce and prevent youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on-one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior. In the 2 months following the intervention, participants will receive booster text messages tailored to their responses during the intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adolescents (ages 14-18) presenting to primary care
• Screen positive for past year violent behavior (physical aggression) toward a friend, stranger, acquaintance, or dating partner (e.g., "have you pushed, hit, slapped, punched, kicked, been in a serious physical fight, group fight, or beat someone up

Exclusion Criteria

• Adolescents who do not understand English
• Adolescents deemed unable to provide informed assent/consent (e.g., mental incompetence)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Maureen A Walton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen A Walton, MPH, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00133654

Identifier Type: -

Identifier Source: org_study_id