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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183400
Acronym
SAFE
Enrollment
244
Registered
2019-12-03
Start date
2015-09-30
Completion date
2020-09-30
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use, Victimization

Keywords

substance use, victimization, homeless youth, youth experiencing homelessness

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.

Interventions

BEHAVIORALSafety Awareness For Empowerment (SAFE)

SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 21 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Substance useFollow up at 6-weeks post baseline interviewThe 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.
VictimizationFollow up at 6-weeks post baseline interviewThe Juvenile Victimization Questionnaire (JVQ) will be used to asses exposure to a range of types of victimization.

Secondary

MeasureTime frameDescription
Risk detectionFollow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baselineRisk 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 intentionsFollow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baselineHelp 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.
Substance use symptomsFollow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baselineThe Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.
AssertivenessFollow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baselineAssertiveness 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
Help seeking behaviorsFollow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baselineHelp 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.
Substance use disorder diagnostic criteriaFollow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baselineThe Mini International Neuropsychiatry Interview (MINI) will be used to assess a whether the participant meets DSM diagnostic criteria for a substance use disorder

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026