Saferteens in Primary Care

November 25, 2019 updated by: Maureen A Walton, University of Michigan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Violent Behavior
Time Frame: 3 months post-baseline
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
Time Frame: 3 months post-baseline
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
Time Frame: 3 months post-baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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