Substance UseSAFENCT04183400
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
A study testing Safety Awareness For Empowerment (SAFE) in people with Substance Use and Victimization, run by University of Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Victimization
- What is being tested?
- Safety Awareness For Empowerment (SAFE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reside at the partnering community based youth shelter
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urban Peak Shelter and University of Denver
Denver, Colorado, 80223
About this study
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.
Read the 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.
- Conditions
- Substance Use, Victimization
- Being tested
- Safety Awareness For Empowerment (SAFE)
- Keywords
- substance use, victimization, homeless youth, youth experiencing homelessness
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Awareness For Empowerment (SAFE)Behavioural
SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
| Study group | Role | What they receive |
|---|---|---|
| Safety Awareness For Empowerment (SAFE) | Experimental | Brief mindfulness-based cognitive-behavioral skill-building intervention Receives: Behavioral: Safety Awareness For Empowerment (SAFE) |
| Usual case management only | No intervention | Control condition receives only services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up at 6-months post baseline interview
Secondary outcomes (6)
Substance use symptoms
The Mini International Neuropsychiatry Interview (MINI) will be used to assess a count of the number of substance use symptoms experienced.
Measured: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
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
Measured: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
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
Measured: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
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.
Measured: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
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.
Measured: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
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
Measured: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startSep 2015
- Primary completionJun 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kimberly Bender, University of Denver
- Investigators
- Kimberly Bender, PhD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183400
- Sponsor's protocol ID
- UDenverSAFE
- Other IDs
- 1R15DA039355-01
- Acronym
- SAFE
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT04183400
- Acronym / sponsor ID
- SAFE / UDenverSAFE
- Conditions
- Substance Use, Victimization
- Keywords
- substance use, victimization, homeless youth, youth experiencing homelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Awareness For Empowerment (SAFE) | Experimental | Behavioral: Safety Awareness For Empowerment (SAFE)Brief mindfulness-based cognitive-behavioral skill-building intervention |
| Usual case management only | No intervention | –Control condition receives only services as usual |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Reside at the partnering community based youth shelter
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Awareness For Empowerment (SAFE)SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills. | Behavioural | Safety Awareness For Empowerment (SAFE) |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Substance use symptoms
Time frame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Substance use disorder diagnostic criteria
Time frame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
Risk detection
Time frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking intentions
Time frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Help seeking behaviors
Time frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Assertiveness
Time frame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Bender, PhD principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Awareness For Empowerment (SAFE) in people with Substance Use and Victimization, run by University of Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use (time frame: Follow up at 6-weeks post baseline interview). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2020.