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

Sponsor
University of Denver (Other)
Overall Status
Completed
CT.gov ID
NCT04183400
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
244
1
2
60
4.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Safety Awareness For Empowerment (SAFE)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
244 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Substance use [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Substance use symptoms [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 21 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urban Peak Shelter and University of Denver Denver Colorado United States 80223

Sponsors and Collaborators

  • University of Denver
  • National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kimberly Bender, Professor, University of Denver
ClinicalTrials.gov Identifier:
NCT04183400
Other Study ID Numbers:
  • UDenverSAFE
  • 1R15DA039355-01
First Posted:
Dec 3, 2019
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kimberly Bender, Professor, University of Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2020