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

U

University of Denver

Status

Completed

Conditions

Victimization
Substance Use

Treatments

Behavioral: Safety Awareness For Empowerment (SAFE)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04183400
UDenverSAFE
1R15DA039355-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

244 patients

Sex

All

Ages

18 to 21 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

244 participants in 2 patient groups

Safety Awareness For Empowerment (SAFE)
Experimental group
Description:
Brief mindfulness-based cognitive-behavioral skill-building intervention
Treatment:
Behavioral: Safety Awareness For Empowerment (SAFE)
Usual case management only
No Intervention group
Description:
Control condition receives only services as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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