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

Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH) Aged 18-25 Years Old

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).

Study Overview

• Status: Completed
• Conditions: Stress, Emotional
• Intervention / Treatment: Behavioral: tailored MBI (.b); Behavioral: attention control condition

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tailored MBI (.b)	Behavioral: 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.
Active Comparator: attention control condition	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Connectedness as Measured Social Connectedness Scale	The scale is a 8 item questionnaire and each item is scored from 1(strongly disagree)-6(strongly agree). The 8 items were added to generate a scale from, 8 to 48, a higher score indicating more connectedness to others.	Baseline
Social Connectedness as Measured Social Connectedness Scale	The scale is a 8 item questionnaire and each item is scored from 1(strongly disagree)-6(strongly agree). The 8 items were added to generate a scale from, 8 to 48, a higher score indicating more connectedness to others.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Social Connectedness as Measured Social Connectedness Scale	The scale is a 8 item questionnaire and each item is scored from 1(strongly disagree)-6(strongly agree). The 8 items were added to generate a scale from, 8 to 48, a higher score indicating more connectedness to others.	3 months post intervention
Social Connectedness as Measured Social Connectedness Scale	The scale is a 8 item questionnaire and each item is scored from 1(strongly disagree)-6(strongly agree). The 8 items were added to generate a scale from, 8 to 48, a higher score indicating more connectedness to others.	6 months post intervention
Depression as Measured by Short Mood and Feelings Questionnaire (SMFQ)	The scale is a 13 item questionnaire and each item is scored from 0(not true)-2(true),higher score indicating worse outcome	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Anxiety as Measured by Spielberger State-Trait Anxiety Inventory	This scale is a 40 item questionnaire, each question is scored from 1(very much so)-4 (not at all), a higher score indicates a worse outcome	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Vulnerability as Measured by Psychological Vulnerability Scale	The Psychological Vulnerability Scale is a 6 item questionnaire. Each item is scored from 1 (does not describe me at all) to 5 (describes me very well). The 6 items were added to generate a scale from 6 to 30, a higher score indicates more vulnerability.	Baseline
Vulnerability as Measured by Psychological Vulnerability Scale	The Psychological Vulnerability Scale is a 6 item questionnaire. Each item is scored from 1 (does not describe me at all) to 5 (describes me very well). The 6 items were added to generate a scale from 6 to 30, a higher score indicates more vulnerability.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Vulnerability as Measured by Psychological Vulnerability Scale	The Psychological Vulnerability Scale is a 6 item questionnaire. Each item is scored from 1 (does not describe me at all) to 5 (describes me very well). The 6 items were added to generate a scale from 6 to 30, a higher score indicates more vulnerability.	3 months post intervention
Vulnerability as Measured by Psychological Vulnerability Scale	The Psychological Vulnerability Scale is a 6 item questionnaire. Each item is scored from 1 (does not describe me at all) to 5 (describes me very well). The 6 items were added to generate a scale from 6 to 30, a higher score indicates more vulnerability.	6 months post intervention
Risk Seeking as Measured by Balloon Analogue Risk Task (BART)	The Balloon Analogue Risk Task (BART) is a computerized measure of risk taking behavior. Each click causes the balloon to incrementally inflate and money to be added to a counter up until some threshold, at which point the balloon is over inflated and explodes. The primary score used to measure BART performance is the adjusted average number of pumps on unexploded balloons, with higher scores indicative of greater risk-taking propensity	Baseline, immediately after intervention (about 2-4 weeks after baseline),3 months post intervention,6 months post intervention
Distress as Measured by Kessler Psychological Distress Scale (K10)	This is a 10-item questionnaire,each item is scored from 1(none of the time)-5(all of the time) for a total score ranging from 10-50 and a higher score indicating worse outcome	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Number of Participants Who Are Sexually Active	A single item question was used to assess this outcome. The item asked whether or not you ever had sexual intercourse. The number of participants who answered yes is reported.	Baseline
Number of Participants Who Are Sexually Active	A single item question was used to assess this outcome. The item asked whether or not you ever had sexual intercourse. The number of participants who answered yes is reported.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Number of Participants Who Are Sexually Active	A single item question was used to assess this outcome. The item asked whether or not you ever had sexual intercourse. The number of participants who answered yes is reported.	3 months post intervention
Number of Participants Who Are Sexually Active	A single item question was used to assess this outcome. The item asked whether or not you ever had sexual intercourse. The number of participants who answered yes is reported.	6 months post intervention
Number of Participants Who Ever Used Drugs or Substances (Marijuana, Prescription Pain Medicine Without a Prescription, Synethic Marijuana, Cocaine, Inhalants, Heroin, Meth, Ecstasy, Injection Drugs)	A single item question was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in their life. The number of participants who answered yes is reported.	Baseline
Number of Participants Who Ever Used Drugs or Substances (Marijuana, Prescription Pain Medicine Without a Prescription, Synethic Marijuana, Cocaine, Inhalants, Heroin, Meth, Ecstasy, Injection Drugs)	A single item question was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in their life. The number of participants who answered yes is reported.	Immediately after completing the intervention (about 2 to 4 weeks after baseline)
Number of Participants Who Ever Used Drugs or Substances (Marijuana, Prescription Pain Medicine Without a Prescription, Synethic Marijuana, Cocaine, Inhalants, Heroin, Meth, Ecstasy, Injection Drugs)	A single item question was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in their life. The number of participants who answered yes is reported.	3 months post intervention
Number of Participants Who Ever Used Drugs or Substances (Marijuana, Prescription Pain Medicine Without a Prescription, Synethic Marijuana, Cocaine, Inhalants, Heroin, Meth, Ecstasy, Injection Drugs)	A single item question was used to assess this outcome. The item listed various drug substances and asked whether any of those listed had been used in their life. The number of participants who answered yes is reported.	6 months post intervention
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire. Each Item is scored from 0 (not at all) to 3 (nearly every day). The 9 items were added to generate a scale from 0 to 27, with higher scores indicating more severe depression.	Baseline
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire. Each Item is scored from 0 (not at all) to 3 (nearly every day). The 9 items were added to generate a scale from 0 to 27, with higher scores indicating more severe depression.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire. Each Item is scored from 0 (not at all) to 3 (nearly every day). The 9 items were added to generate a scale from 0 to 27, with higher scores indicating more severe depression.	3 months post intervention
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire. Each Item is scored from 0 (not at all) to 3 (nearly every day). The 9 items were added to generate a scale from 0 to 27, with higher scores indicating more severe depression.	6 months post intervention
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale	The Anxiety as Measured by Generalized Anxiety Disorder (GAD) scale is a 7 item questionnaire. Each item is scored from 0 (not at all) to 3 (nearly every day). The 7 items were added to generate a scale from 0 to 21, with higher scores indicating greater severity of symptoms of anxiety.	Baseline
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale	The Anxiety as Measured by Generalized Anxiety Disorder (GAD) scale is a 7 item questionnaire. Each item is scored from 0 (not at all) to 3 (nearly every day). The 7 items were added to generate a scale from 0 to 21, with higher scores indicating greater severity of symptoms of anxiety.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale	The Anxiety as Measured by Generalized Anxiety Disorder (GAD) scale is a 7 item questionnaire. Each item is scored from 0 (not at all) to 3 (nearly every day). The 7 items were added to generate a scale from 0 to 21, with higher scores indicating greater severity of symptoms of anxiety.	3 months post intervention
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale	The Anxiety as Measured by Generalized Anxiety Disorder (GAD) scale is a 7 item questionnaire. Each item is scored from 0 (not at all) to 3 (nearly every day). The 7 items were added to generate a scale from 0 to 21, with higher scores indicating greater severity of symptoms of anxiety.	6 months post intervention
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress	The Promise item bank v.1.0- Emotional Distress 7 item questionnaire includes responses from 1 (never) to 5 (always). Total score ranges from 7 to 35, a higher score indicating higher emotional distress.	Baseline
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress	The Promise item bank v.1.0- Emotional Distress 7 item questionnaire includes responses from 1 (never) to 5 (always). Total score ranges from 7 to 35, a higher score indicating higher emotional distress.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress	The Promise item bank v.1.0- Emotional Distress 7 item questionnaire includes responses from 1 (never) to 5 (always). Total score ranges from 7 to 35, a higher score indicating higher emotional distress.	3 months post intervention
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress	The Promise item bank v.1.0- Emotional Distress 7 item questionnaire includes responses from 1 (never) to 5 (always). Total score ranges from 7 to 35, a higher score indicating higher emotional distress.	6 months post intervention
Risk Seeking as Measured by Risk Propensity Scale.	The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.	Baseline
Risk Seeking as Measured by Risk Propensity Scale.	The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Risk Seeking as Measured by Risk Propensity Scale.	The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.	3 months post intervention
Risk Seeking as Measured by Risk Propensity Scale.	The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.	6 months post intervention
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)	Executive Function as Measured by the 13 item Amsterdam Executive Function Inventory (AEFI) total score ranges from 1 (true) to 3 (not true), higher score indicates better executive abilities.	Baseline
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)	Executive Function as Measured by the 13 item Amsterdam Executive Function Inventory (AEFI) total score ranges from 1 (true) to 3 (not true), higher score indicates better executive abilities.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)	Executive Function as Measured by the 13 item Amsterdam Executive Function Inventory (AEFI) total score ranges from 1 (true) to 3 (not true), higher score indicates better executive abilities.	3 months post intervention
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)	Executive Function as Measured by the 13 item Amsterdam Executive Function Inventory (AEFI) total score ranges from 1 (true) to 3 (not true), higher score indicates better executive abilities.	6 months post intervention
Positive Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)	PANAS-SF is a 20 item questionnaire, each item is scored from 1(very slightly or not at all)-5(extremely). Positive affect is measured by 10 items (items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19) score ranges for 10-50 with higher scores indicating higher levels of positive effect. The Positive affect score is reported.	Baseline
Positive Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)	PANAS-SF is a 20 item questionnaire, each item is scored from 1(very slightly or not at all)-5(extremely). Positive affect is measured by 10 items (items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19) score ranges for 10-50 with higher scores indicating higher levels of positive effect. The Positive affect score is reported.	immediately after completing the intervention (about 2 to 4 weeks after baseline)
Negative Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)	PANAS-SF is a 20 item questionnaire, each item is scored from 1(very slightly or not at all)-5(extremely). Negative affect is measured by 10 items (items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20) score ranges from 10-50, with lower scores indicating lower levels of negative effect. The negative affect score is reported.	Baseline
Negative Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)	PANAS-SF is a 20 item questionnaire, each item is scored from 1(very slightly or not at all)-5(extremely). Negative affect is measured by 10 items (items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20) score ranges from 10-50, with lower scores indicating lower levels of negative effect. The negative affect score is reported.	immediately after completing the intervention (about 2 to 4 weeks after baseline)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): June 8, 2024
• Study Completion (Actual): June 8, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Stress, Psychological
• Other Study ID Numbers: HSC-SN-20-0466 (Aim 3 Pilot); 5R34AT010672-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No