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

Substance Use Clinical Trial

— SAFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183400
• Other study ID #: UDenverSAFE
• Secondary ID: 1R15DA039355-01
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: University of Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Victimization

Intervention

Behavioral:
• Safety Awareness For Empowerment (SAFE)
SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.

Locations

Country	Name	City	State
United States	Urban Peak Shelter and University of Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Denver	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Substance use symptoms	The Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.	Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Secondary	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	Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Secondary	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	Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Secondary	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.	Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Secondary	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.	Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Secondary	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	Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline