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Completed

NCT Number: NCT04183400

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

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Victimization

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urban Peak Shelter and University of Denver

Denver, Colorado, 80223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safety Awareness For Empowerment (SAFE)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

University of Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: SAFE

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2019
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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