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

Primary Purpose

Substance Use, Victimization

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Awareness For Empowerment (SAFE)
Sponsored by
University of Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring substance use, victimization, homeless youth, youth experiencing homelessness

Eligibility Criteria

18 Years - 21 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Urban Peak Shelter and University of Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safety Awareness For Empowerment (SAFE)

Usual case management only

Arm Description

Brief mindfulness-based cognitive-behavioral skill-building intervention

Control condition receives only services as usual

Outcomes

Primary Outcome Measures

Substance use
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.
Substance use
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.
Substance use
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.
Victimization
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Victimization
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Victimization
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.

Secondary Outcome Measures

Substance use symptoms
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.
Substance use disorder diagnostic criteria
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a whether the participant meets DSM diagnostic criteria for a substance use disorder
Risk detection
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
Help seeking intentions
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.
Help seeking behaviors
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.
Assertiveness
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

Full Information

First Posted
November 15, 2019
Last Updated
September 25, 2020
Sponsor
University of Denver
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04183400
Brief Title
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Acronym
SAFE
Official Title
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Denver
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Victimization
Keywords
substance use, victimization, homeless youth, youth experiencing homelessness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Awareness For Empowerment (SAFE)
Arm Type
Experimental
Arm Description
Brief mindfulness-based cognitive-behavioral skill-building intervention
Arm Title
Usual case management only
Arm Type
No Intervention
Arm Description
Control condition receives only services as usual
Intervention Type
Behavioral
Intervention Name(s)
Safety Awareness For Empowerment (SAFE)
Intervention Description
SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
Primary Outcome Measure Information:
Title
Substance use
Description
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.
Time Frame
Follow up at 6-weeks post baseline interview
Title
Substance use
Description
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.
Time Frame
Follow up at 3-months post baseline interview
Title
Substance use
Description
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.
Time Frame
Follow up at 6-months post baseline interview
Title
Victimization
Description
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Time Frame
Follow up at 6-weeks post baseline interview
Title
Victimization
Description
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Time Frame
Follow up at 3-months post baseline interview
Title
Victimization
Description
The Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.
Time Frame
Follow up at 6-months post baseline interview
Secondary Outcome Measure Information:
Title
Substance use symptoms
Description
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.
Time Frame
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Title
Substance use disorder diagnostic criteria
Description
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a whether the participant meets DSM diagnostic criteria for a substance use disorder
Time Frame
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Title
Risk detection
Description
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
Time Frame
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Title
Help seeking intentions
Description
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.
Time Frame
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Title
Help seeking behaviors
Description
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.
Time Frame
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Title
Assertiveness
Description
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
Time Frame
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Bender, PhD
Organizational Affiliation
University of Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urban Peak Shelter and University of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80223
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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