Saferteens in Primary Care

NCT03410238 | Completed

• 1 other identifier: HUM00133654
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Saferteens Brief Intervention

Control

NO INTERVENTION

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

Interventions

Saferteens Brief Intervention 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.

Treatment

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Maureen A Walton, MPH, PHD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 25, 2018
• Study Start: June 7, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

US (1)