NCT02136225

Brief Summary

The purpose of this project is to examine the implementation and effectiveness of an intervention, delivered in a health care setting, to decrease home firearm access by youth. The investigators hypothesize that:

  1. 1.parents who receive means restriction education provided by their primary care provider will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who do not receive means restriction counseling.
  2. 2.parents who receive a free gun locking device(s) will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who receive means restriction counseling alone;
  3. 3.parents whose adolescents are assessed at high risk for violence (\> 5 on the Violence Injury Protection and Risk Screen (VIPRS)) or depression (\>9 on the Patient Health Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at the one month follow-up compared to parents whose children are assessed as low risk, regardless of whether they receive the counseling alone or counseling plus free locking devices and 4) youth whose parents receive a free gun locking device(s) will be more likely to report less access to guns, at one year follow-up, compared to parents who receive means restriction counseling alone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

4.8 years

First QC Date

May 8, 2014

Last Update Submit

April 27, 2019

Conditions

Keywords

youthgunaccesshome

Outcome Measures

Primary Outcomes (2)

  • Change from baseline to one month and one year in the reported number of guns locked in the home.

    The study examines whether the youth and parents in the treatment groups leads to an increase in the number of guns stored securely (locked) in their home.

    Baseline, one month, 1 year

  • Change from baseline to one month and one year in the reported number of locking devices parents use to store their guns.

    This study examines whether the youth and parents in the second treatment group, receiving means restriction counseling and locking devices, will increase their use of locking devices compared to youth and parents in the means restriction alone and control groups.

    Baseline, one month, one year

Secondary Outcomes (1)

  • Change from baseline to one month and one year in the number of gun(s) reported locked in their home among parents whose youth are at high risk for violence or depression.

    Baseline, one month, one year

Study Arms (3)

Counseling

EXPERIMENTAL

Intervention: Means restriction counseling. Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun in the home where youth are present.

Behavioral: Means restriction counseling

Counseling and locking devices

EXPERIMENTAL

Intervention: Means restriction counseling and locking devices. Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present. Parents will also receive locking devices to store their guns securely.

Behavioral: Means restriction counseling

Control group

NO INTERVENTION

Youth in the control group will receive usual care.

Interventions

Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.

CounselingCounseling and locking devices

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient at the Children's Hospital Colorado in the Adolescent Medicine Clinic
  • Scheduled for any type of appointment
  • Reports having a gun in the home

You may not qualify if:

  • Adolescent or parent speaks/reads a language other than English or Spanish
  • Adolescent has cognitive disabilities
  • Adolescent resides in a group home or detention center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Eric Sigel, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04