Saferteens in Primary Care

Translation of an Evidenced-Based Violence Intervention for Adolescents in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Violence
• Intervention / Treatment: Behavioral: Saferteens Brief Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants receive Saferteens Brief Intervention and a brochure containing psycho-education and resources.	Behavioral: 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.
No Intervention: Control; Participants receive a brochure containing psycho-education and resources only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Violent Behavior	Change in violent behavior is assessed using 10 validated items from the National Longitudinal Study of Adolescent Health and Conflict Tactics Scale and assess the frequency of moderate (e.g., pushed or shoved) and severe (e.g., hit or punched, used a knife/gun) aggression towards peers. A composite score will be computed by summing the midpoint of responses to facilitate assessing change between baseline and follow-up.	3 months post-baseline
Change in Victimization by peers	Change in victimization by peers is assessed using 2 validated items from the Conflict Tactics Scale which assess the frequency of moderate and severe peer victimization. A composite score will be computed by summing the midpoint of the items to facilitate measuring change between baseline and follow-up.	3 months post-baseline
Change in Violence Consequences	Change in violence consequences is assessed using a 7 item scale. This scale was developed for the original SafERteens study and inquires about possible consequences of fighting, like trouble at school and expressed concern about fighting by family members or friends. A composite score will be computed to facilitate measuring change between baseline and follow-up.	3 months post-baseline

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HUM00133654

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No