Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness (SAFE)

September 25, 2020 updated by: Kimberly Bender, University of Denver
The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to receive the SAFE intervention (plus usual case management) or to receive usual case management only. Those assigned to SAFE will receive 12 mindfulness-based, cognitive-behavioral modules through a 3-day intensive group intervention provided by an agency intern and a hired project staff member. The intervention uses mindfulness-based cognitive-behavioral approaches to augment youth attention to risk-related processes, including risk detection, problem solving, assertiveness, and help seeking skills. It is hypothesized the intervention will result in reduced substance use and victimization and that these effects will be explained, at least in part, by improved risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking skills). Post baseline interview, participants will be randomly assigned and will participate in a posttest interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months post baseline interview.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • 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
    • Colorado
      • Denver, Colorado, United States, 80223
        • Urban Peak Shelter and University of Denver

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

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Reside at the partnering community based youth shelter

Exclusion Criteria:

As measured by the KSADS (a semi-structured diagnostic interview administered by trained interviewers at baseline):

  • presence of psychotic symptoms;
  • presence of a life-threatening medical/chronic neurological illness that would prevent participation in a 4-day intervention and/or assessments;
  • suicide attempt in last 6 months without current enrollment in therapy or related services to address;
  • chronic self-injurious behavior/cutting without current enrollment in therapy or related services to address
  • hospitalization or residential treatment for psychiatric reasons in last 6 months without current enrollment in therapy or related services to address.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety Awareness For Empowerment (SAFE)
Brief mindfulness-based cognitive-behavioral skill-building intervention
Behavioral: Safety Awareness For Empowerment (SAFE)
SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
No Intervention: Usual case management only
Control condition receives only services as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance use
Time Frame: Follow up at 6-weeks post baseline interview
The Substance use domain of the Addiction Severity Index, 5th edition will be used to assess the frequency, type and amount of substance use in the past 30 days. This domain will be adapted to add smoking tobacco to the list of substances.
Follow up at 6-weeks post baseline interview
Substance use
Time Frame: Follow up at 3-months post baseline interview
The Substance use domain of the Addiction Severity Index, 5th edition will be used to assess the frequency, type and amount of substance use in the past 30 days. This domain will be adapted to add smoking tobacco to the list of substances.
Follow up at 3-months post baseline interview
Substance use
Time Frame: Follow up at 6-months post baseline interview
The Substance use domain of the Addiction Severity Index, 5th edition will be used to assess the frequency, type and amount of substance use in the past 30 days. This domain will be adapted to add smoking tobacco to the list of substances.
Follow up at 6-months post baseline interview
Victimization
Time Frame: Follow up at 6-weeks post baseline interview
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Follow up at 6-weeks post baseline interview
Victimization
Time Frame: Follow up at 3-months post baseline interview
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Follow up at 3-months post baseline interview
Victimization
Time Frame: Follow up at 6-months post baseline interview
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Follow up at 6-months post baseline interview

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance use symptoms
Time Frame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Substance use disorder diagnostic criteria
Time Frame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a whether the participant meets DSM diagnostic criteria for a substance use disorder
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Risk detection
Time Frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Risk detection will be assessed a set of researcher-developed Risk Vignettes that describe characters in risk situations and ask participants to identify risk cues present; measure will be proportion of risk cues identified among those present in the vignettes administered
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking intentions
Time Frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking intentions will be assessed with a modified version of the General Help Seeking Questionnaire which assesses intentions to seek help from different sources for different problems. The original scale asks about seeking help for emotional problems and suicidal thoughts; our version was modified to ask about help seeking related to safety issues and substance use. Higher scores indicate greater help seeking thus a more positive outcome.
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking behaviors
Time Frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking behaviors will be assessed by items from the Help Seeking Behaviors scale which ask how often youth actually sought help fro different sources of help for substance and for safety.
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Assertiveness
Time Frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Assertiveness will be assessed using the Assertion Inventory which asks how often participants engage in assertive behaviors across three domains: substance use, general, and social situations
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline

Collaborators and Investigators

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

Sponsor

University of Denver

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kimberly Bender, PhD, University of Denver

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)

September 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 27, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDenverSAFE
  • 1R15DA039355-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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