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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Suicide Prevention Among Substance Abusing Homeless Youth

NCT02576834

Suicide

COMPLETED NA

Impact of Mindfulness Training on Adolescent Well-Being and Behavior

NCT05537961

Substance Use Mindfulness Psychological Well-being

COMPLETED NA

Digital Mindfulness-Based Treatment for Substance Use Disorder Recovery

NCT05852015

Substance Use Disorders

COMPLETED NA

Mindfulness for at Risk Youth: Understanding Substance Use and Important Mechanisms of Change

NCT04160754

Alcohol Use, Underage Alcohol Problem Drinking Substance Use

COMPLETED NA

Performance-based Reinforcement to Enhance Cognitive Remediation Therapy

NCT01633138

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Victimization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safety Awareness For Empowerment (SAFE)

Brief mindfulness-based cognitive-behavioral skill-building intervention

Group Type EXPERIMENTAL

Safety Awareness For Empowerment (SAFE)

Intervention Type BEHAVIORAL

SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.

Usual case management only

Control condition receives only services as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safety Awareness For Empowerment (SAFE)

SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes