Clinical trial NCT04183400: Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Official title: Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Victimization
Keywords: substance use
victimization
homeless youth
youth experiencing homelessness
Lead sponsor: University of Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-03
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Substance use
timeFrame: Follow up at 6-weeks post baseline interview
measure: Substance use
timeFrame: Follow up at 3-months post baseline interview
measure: Substance use
timeFrame: Follow up at 6-months post baseline interview
measure: Victimization
timeFrame: Follow up at 6-weeks post baseline interview
measure: Victimization
timeFrame: Follow up at 3-months post baseline interview
measure: Victimization
timeFrame: Follow up at 6-months post baseline interview
Secondary outcomes:
measure: Substance use symptoms
timeFrame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
measure: Substance use disorder diagnostic criteria
timeFrame: Follow up at 6-weeks, 3-months, and 6-months post baseline interview, controlling for baseline
measure: Risk detection
timeFrame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
measure: Help seeking intentions
timeFrame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
measure: Help seeking behaviors
timeFrame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
measure: Assertiveness
timeFrame: Follow up at 1-week, 6-weeks, and 3-months post baseline interview, controlling for baseline
Other outcomes:
Locations:
city: Denver
country: United States
facility: Urban Peak Shelter and University of Denver
state: Colorado
Study officials:
affiliation: University of Denver
name: Kimberly Bender, PhD
role: PRINCIPAL_INVESTIGATOR
References: