Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH)

NCT ID: NCT04950816

Last Updated: 2025-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2024-06-08

Brief Summary

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The purpose of this study is to conduct a trial of the tailored Mindfulness- Based Intervention (MBI) (.b) vs. attention control to test real-world feasibility and acceptability of this tailored Mindfulness - Based Intervention (MBI) in youth experiencing homelessness (YEH).

Detailed Description

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Conditions

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Stress, Emotional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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tailored MBI (.b)

Group Type EXPERIMENTAL

tailored MBI (.b)

Intervention Type BEHAVIORAL

The session will include brief didactic presentations, videos, and mindfulness practice followed by inquiry. We anticipate that sessions will take place twice a week. Sessions will be held on site at the Covenant House Texas (CHT) shelter in a quiet, designated learning space to ease access to sessions for the participants and to assure access to shelter staff (e.g., social workers and case managers) and services (e.g., food and shelter). CHT has onsite, weekday clinical and mental health care and established protocols for accessing needed resources 24/7. Selection criteria for the interventionist include maintaining a personal mindfulness practice for at least two years, trained in .b, and prior experience working with high-risk youth. The interventionist will receive additional training in Trauma-Informed Care as well as study procedures.

attention control condition

Group Type ACTIVE_COMPARATOR

attention control condition

Intervention Type BEHAVIORAL

Participants will receive no training in MBI or meditation. Topics covered may include physical activity, nutrition, managing weight, understanding adolescence, personal care, avoiding tobacco, alcohol, and drugs though this will be finalized in YR-1 with the HYWG and advisory panel. The HT program will be led by a positive adult instructor with training in health education or a related field and experience working with YEH.

Interventions

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tailored MBI (.b)

The session will include brief didactic presentations, videos, and mindfulness practice followed by inquiry. We anticipate that sessions will take place twice a week. Sessions will be held on site at the Covenant House Texas (CHT) shelter in a quiet, designated learning space to ease access to sessions for the participants and to assure access to shelter staff (e.g., social workers and case managers) and services (e.g., food and shelter). CHT has onsite, weekday clinical and mental health care and established protocols for accessing needed resources 24/7. Selection criteria for the interventionist include maintaining a personal mindfulness practice for at least two years, trained in .b, and prior experience working with high-risk youth. The interventionist will receive additional training in Trauma-Informed Care as well as study procedures.

Intervention Type BEHAVIORAL

attention control condition

Participants will receive no training in MBI or meditation. Topics covered may include physical activity, nutrition, managing weight, understanding adolescence, personal care, avoiding tobacco, alcohol, and drugs though this will be finalized in YR-1 with the HYWG and advisory panel. The HT program will be led by a positive adult instructor with training in health education or a related field and experience working with YEH.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* homeless youth receiving services at one of the recruitment sites in Houston, Texas area at the time of enrollment
* English speaking
* able to participate for the entire study period (i.e., not moving during the study)

Exclusion Criteria

* overtly exhibiting symptoms of severe, untreated mental illness criteria
* not staying at the shelter
* currently experiencing homelessness or unstable housing
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Diane Santa Maria

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5R34AT010672-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SN-20-0466 (Aim 3 Pilot)

Identifier Type: -

Identifier Source: org_study_id

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