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

NCT04950816 | Completed Results DMC

• 2 other identifiers: HSC-SN-20-0466 (Aim 3 Pilot)5R34AT010672-03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stress, Emotional

Outcome Measures

Primary Outcomes (23)

• Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

  The DERS is a 36-item questionnaire, and each item is scored from 1(almost never)-5 (almost always). The 36 items were added to generate a scale from 36 to 180, a higher score indicates greater problem with emotion regulation.

  Baseline

• Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

  The DERS is a 36-item questionnaire, and each item is scored from 1(almost never)-5 (almost always). The 36 items were added to generate a scale from 36 to 180, a higher score indicates greater problem with emotion regulation.

  immediately after completing the intervention (about 2 to 4 weeks after baseline)

• Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

  The DERS is a 36-item questionnaire, and each item is scored from 1(almost never)-5 (almost always). The 36 items were added to generate a scale from 36 to 180, a higher score indicates greater problem with emotion regulation.

  3 months post intervention

• Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

  The DERS is a 36-item questionnaire, and each item is scored from 1(almost never)-5 (almost always). The 36 items were added to generate a scale from 36 to 180, a higher score indicates greater problem with emotion regulation.

  6 months post intervention

• Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

  The CAMM is a 10 item questionnaire and each item is scored from 0(never true)-4 (always true). The 10 items were added to generate a scale from 0 to 40, a higher score indicates higher levels of mindfulness

  Baseline

• Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

  The CAMM is a 10 item questionnaire and each item is scored from 0(never true)-4 (always true). The 10 items were added to generate a scale from 0 to 40, a higher score indicates higher levels of mindfulness

  immediately after completing the intervention (about 2 to 4 weeks after baseline)

• Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

  The CAMM is a 10 item questionnaire and each item is scored from 0(never true)-4 (always true). The 10 items were added to generate a scale from 0 to 40, a higher score indicates higher levels of mindfulness

  3 months post intervention

• Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

  The CAMM is a 10 item questionnaire and each item is scored from 0(never true)-4 (always true). The 10 items were added to generate a scale from 0 to 40, a higher score indicates higher levels of mindfulness

  6 months post intervention

• Mindfulness as Measured by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  The CAMS-R is a 12-item measure and each item is scored from 1( rarely/not at all)-4(almost always). Higher values reflect greater mindful qualities

  Baseline, immediately after intervention (about 2 to 4 weeks after baseline),3 months post intervention,6 months post intervention

• Self-Compassion as Measured by Self-Compassion Scale (SCS)

  The Self-Compassion Scale (SCS) total score ranges from 1 to 5, higher score indicating greater self compassion..

  Baseline

• Self-Compassion as Measured by Self-Compassion Scale (SCS)

  The Self-Compassion Scale (SCS) total score ranges from 1 to 5, higher score indicating greater self compassion.

  immediately after completing the intervention (about 2 to 4 weeks after baseline)

• Self-Compassion as Measured by Self-Compassion Scale (SCS)

  The Self-Compassion Scale (SCS) total score ranges from 1 to 5, higher score indicating greater self compassion.

  3 months post intervention

• Self-Compassion as Measured by Self-Compassion Scale (SCS)

  The Self-Compassion Scale (SCS) total score ranges from 1 to 5, higher score indicating greater self compassion.

  6 months post intervention

• Stress as Measured by Perceived Stress Scale (PSS)

  The PSS is a 10 item questionnaire and each item is scored from 0(never)-4(very often). The 10 items were added to generate a scale from 0 to 40, higher score indicating a higher perceived stress.

  Baseline

• Stress as Measured by Perceived Stress Scale (PSS)

  The PSS is a 10 item questionnaire and each item is scored from 0(never)-4(very often). The 10 items were added to generate a scale from 0 to 40, higher score indicating a higher perceived stress.

  immediately after completing the intervention (about 2 to 4 weeks after baseline)

• Stress as Measured by Perceived Stress Scale (PSS)

  The PSS is a 10 item questionnaire and each item is scored from 0(never)-4(very often). The 10 items were added to generate a scale from 0 to 40, higher score indicating a higher perceived stress.

  3 months post intervention

• Stress as Measured by Perceived Stress Scale (PSS)

  The PSS is a 10 item questionnaire and each item is scored from 0(never)-4(very often). The 10 items were added to generate a scale from 0 to 40, higher score indicating a higher perceived stress.

  6 months post intervention

• Feasibility as Assessed by the Percentage of Participants Enrolled in the Study

  Percentage of participants who met study eligibility criteria who enroll (provide informed consent) in the study

  Baseline

• Feasibility as Assessed by the Number of Participants Who Adhere to Treatment

  Number of participants who adhere to treatment is measured by the number of participants who attended at least 3 of 5 group sessions.

  6 months post intervention

• Feasibility as Assessed by the Number of Participants Who Completed the 3 Months Follow up

  3 months post intervention

• Feasibility as Assessed by the Number of Participants Who Completed the 6 Months Follow up

  6 months post intervention

• Acceptability as Assessed by the Credibility and Expectancy Questionnaire - Expectancy Subscale

  The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The expectancy subscale is reported.

  6 months post intervention

• Acceptability as Assessed by the Credibility and Expectancy Questionnaire - Credibility Subscale

  The Credibility and Expectancy Questionnaire (CEQ) was used to assess the acceptability of the intervention. All participants completed both subscales: the credibility subscale and the expectancy subscale. Each subscale total score ranges from 0 to 10, with higher scores indicating greater perceived acceptability. The credibility subscale is reported.

  6 months post intervention

Secondary Outcomes (44)

• Social Connectedness as Measured Social Connectedness Scale

  Baseline

• Social Connectedness as Measured Social Connectedness Scale

  immediately after completing the intervention (about 2 to 4 weeks after baseline)

• Social Connectedness as Measured Social Connectedness Scale

  3 months post intervention

• Social Connectedness as Measured Social Connectedness Scale

  6 months post intervention

• Depression as Measured by Short Mood and Feelings Questionnaire (SMFQ)

  Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention

Study Arms (2)

tailored MBI (.b)

EXPERIMENTAL

Behavioral: tailored MBI (.b)

attention control condition

ACTIVE COMPARATOR

Behavioral: attention control condition

Interventions

tailored MBI (.b) 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.

tailored MBI (.b)

attention control condition 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.

attention control condition

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Diane Santa Maria, DrPH
• Organization: The University of Texas Health Science Center at Houston

diane.m.santamaria@uth.tmc.edu

713-500-2187

Study Officials

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

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: March 28, 2022
• Primary Completion: June 8, 2024
• Study Completion: June 8, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)