Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
SAFE
2 other identifiers
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
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
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 15, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 28, 2020
September 1, 2020
4.8 years
November 15, 2019
September 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Follow up at 6-weeks post baseline interview
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.
Follow up at 3-months post baseline interview
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.
Follow up at 6-months post baseline interview
Victimization
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
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
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 Outcomes (6)
Substance use symptoms
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Substance use disorder diagnostic criteria
Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Risk detection
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking intentions
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking behaviors
Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
- +1 more secondary outcomes
Study Arms (2)
Safety Awareness For Empowerment (SAFE)
EXPERIMENTALBrief mindfulness-based cognitive-behavioral skill-building intervention
Usual case management only
NO INTERVENTIONControl condition receives only services as usual
Interventions
SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
Eligibility Criteria
You may qualify if:
- Reside at the partnering community based youth shelter
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Denverlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Urban Peak Shelter and University of Denver
Denver, Colorado, 80223, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Bender, PhD
University of Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2019
First Posted
December 3, 2019
Study Start
September 1, 2015
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
September 28, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share