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Completed

NCT Number: NCT04950816

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

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).

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Key information

Conditions

Stress, Emotional Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Baseline

    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.

  2. Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

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

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

    Time frame: 3 months post intervention

    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.

  4. Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS)

    Time frame: 6 months post intervention

    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.

  5. Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: Baseline

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

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

    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

  7. Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: 3 months post intervention

    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

  8. Mindfulness as Measured by Child and Adolescent Mindfulness Measure (CAMM)

    Time frame: 6 months post intervention

    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

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

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

    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

  10. Self-Compassion as Measured by Self-Compassion Scale (SCS)

    Time frame: Baseline

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

  11. Self-Compassion as Measured by Self-Compassion Scale (SCS)

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

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

  12. Self-Compassion as Measured by Self-Compassion Scale (SCS)

    Time frame: 3 months post intervention

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

  13. Self-Compassion as Measured by Self-Compassion Scale (SCS)

    Time frame: 6 months post intervention

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

  14. Stress as Measured by Perceived Stress Scale (PSS)

    Time frame: Baseline

    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.

  15. Stress as Measured by Perceived Stress Scale (PSS)

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

    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.

  16. Stress as Measured by Perceived Stress Scale (PSS)

    Time frame: 3 months post intervention

    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.

  17. Stress as Measured by Perceived Stress Scale (PSS)

    Time frame: 6 months post intervention

    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.

  18. Feasibility as Assessed by the Percentage of Participants Enrolled in the Study

    Time frame: Baseline

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

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

    Time frame: 6 months post intervention

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

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

    Time frame: 3 months post intervention

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

    Time frame: 6 months post intervention

  22. Acceptability as Assessed by the Credibility and Expectancy Questionnaire - Expectancy Subscale

    Time frame: 6 months post intervention

    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.

  23. Acceptability as Assessed by the Credibility and Expectancy Questionnaire - Credibility Subscale

    Time frame: 6 months post intervention

    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.

Secondary outcomes

  1. Social Connectedness as Measured Social Connectedness Scale

    Time frame: Baseline

    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.

  2. Social Connectedness as Measured Social Connectedness Scale

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

    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. Social Connectedness as Measured Social Connectedness Scale

    Time frame: 3 months post intervention

    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.

  4. Social Connectedness as Measured Social Connectedness Scale

    Time frame: 6 months post intervention

    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.

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

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

    The scale is a 13 item questionnaire and each item is scored from 0(not true)-2(true),higher score indicating worse outcome

  6. Anxiety as Measured by Spielberger State-Trait Anxiety Inventory

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

    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

  7. Vulnerability as Measured by Psychological Vulnerability Scale

    Time frame: Baseline

    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.

  8. Vulnerability as Measured by Psychological Vulnerability Scale

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

    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.

  9. Vulnerability as Measured by Psychological Vulnerability Scale

    Time frame: 3 months post intervention

    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.

  10. Vulnerability as Measured by Psychological Vulnerability Scale

    Time frame: 6 months post intervention

    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.

  11. Risk Seeking as Measured by Balloon Analogue Risk Task (BART)

    Time frame: Baseline, immediately after intervention (about 2-4 weeks after baseline),3 months post intervention,6 months post intervention

    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

  12. Distress as Measured by Kessler Psychological Distress Scale (K10)

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

    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

  13. Number of Participants Who Are Sexually Active

    Time frame: Baseline

    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.

  14. Number of Participants Who Are Sexually Active

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

    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.

  15. Number of Participants Who Are Sexually Active

    Time frame: 3 months post intervention

    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.

  16. Number of Participants Who Are Sexually Active

    Time frame: 6 months post intervention

    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.

  17. 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)

    Time frame: Baseline

    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.

  18. 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)

    Time frame: Immediately after completing the intervention (about 2 to 4 weeks after baseline)

    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.

  19. 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)

    Time frame: 3 months post intervention

    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.

  20. 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)

    Time frame: 6 months post intervention

    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.

  21. Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline

    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.

  22. Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)

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

    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.

  23. Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 3 months post intervention

    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.

  24. Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 6 months post intervention

    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.

  25. Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale

    Time frame: Baseline

    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.

  26. Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale

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

    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.

  27. Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale

    Time frame: 3 months post intervention

    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.

  28. Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale

    Time frame: 6 months post intervention

    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.

  29. Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress

    Time frame: Baseline

    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.

  30. Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress

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

    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.

  31. Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress

    Time frame: 3 months post intervention

    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.

  32. Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress

    Time frame: 6 months post intervention

    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.

  33. Risk Seeking as Measured by Risk Propensity Scale.

    Time frame: Baseline

    The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.

  34. Risk Seeking as Measured by Risk Propensity Scale.

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

    The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.

  35. Risk Seeking as Measured by Risk Propensity Scale.

    Time frame: 3 months post intervention

    The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.

  36. Risk Seeking as Measured by Risk Propensity Scale.

    Time frame: 6 months post intervention

    The Risk Propensity Scale is 7 items and total score ranges from 0 to 100, a higher score indicating greater risk taking.

  37. Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)

    Time frame: Baseline

    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.

  38. Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)

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

    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.

  39. Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)

    Time frame: 3 months post intervention

    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.

  40. Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)

    Time frame: 6 months post intervention

    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.

  41. Positive Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)

    Time frame: Baseline

    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.

  42. Positive Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)

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

    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.

  43. Negative Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)

    Time frame: Baseline

    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.

  44. Negative Affect as Measured by Positive and Negative Affect Scale (PANAS-SF)

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

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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