Stress, EmotionalNCT04950816
Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH)
A study testing tailored MBI (.b) in people with Stress, Emotional, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Stress, Emotional
- What is being tested?
- tailored MBI (.b)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 8 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- overtly exhibiting symptoms of severe, untreated mental illness criteria
- not staying at the shelter
- currently experiencing homelessness or unstable housing
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official 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
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
- Being tested
- tailored MBI (.b), attention control condition
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored MBI (.b)Behavioural
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 conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| tailored MBI (.b) | Experimental | Not described Receives: Behavioral: tailored MBI (.b) |
| attention control condition | Active comparator | Not described Receives: Behavioral: attention control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 months post intervention
Feasibility as Assessed by the Number of Participants Who Completed the 3 Months Follow up
Measured: 3 months post intervention
Feasibility as Assessed by the Number of Participants Who Completed the 6 Months Follow up
Measured: 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.
Measured: 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.
Measured: 6 months post intervention
Secondary outcomes (44)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start28 Mar 2022
- Primary completion8 Jun 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Diane Santa Maria, The University of Texas Health Science Center, Houston
- Investigators
- Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950816
- Sponsor's protocol ID
- HSC-SN-20-0466 (Aim 3 Pilot)
- Other IDs
- 5R34AT010672-03
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2021
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04950816
- Acronym / sponsor ID
- HSC-SN-20-0466 (Aim 3 Pilot)
- Conditions
- Stress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tailored MBI (.b) | Experimental | Behavioral: tailored MBI (.b) |
| attention control condition | Active comparator | Behavioral: attention control condition |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- overtly exhibiting symptoms of severe, untreated mental illness criteria
- not staying at the shelter
- currently experiencing homelessness or unstable housing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | tailored MBI (.b) |
| attention control conditionParticipants 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. | Behavioural | attention control condition |
Primary outcome
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.
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.
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.
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.
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
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
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
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
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
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..
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.
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.
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.
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.
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.
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.
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.
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
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.
Feasibility as Assessed by the Number of Participants Who Completed the 3 Months Follow up
Time frame: 3 months post intervention
Feasibility as Assessed by the Number of Participants Who Completed the 6 Months Follow up
Time frame: 6 months post intervention
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.
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.
44 secondary outcomes
Social Connectedness as Measured Social Connectedness Scale
Time frame: Baseline
Social Connectedness as Measured Social Connectedness Scale
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Social Connectedness as Measured Social Connectedness Scale
Time frame: 3 months post intervention
Social Connectedness as Measured Social Connectedness Scale
Time frame: 6 months post intervention
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
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
Vulnerability as Measured by Psychological Vulnerability Scale
Time frame: Baseline
Vulnerability as Measured by Psychological Vulnerability Scale
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Vulnerability as Measured by Psychological Vulnerability Scale
Time frame: 3 months post intervention
Vulnerability as Measured by Psychological Vulnerability Scale
Time frame: 6 months post intervention
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
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
Number of Participants Who Are Sexually Active
Time frame: Baseline
Number of Participants Who Are Sexually Active
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Number of Participants Who Are Sexually Active
Time frame: 3 months post intervention
Number of Participants Who Are Sexually Active
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 months post intervention
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months post intervention
Depression as Measured by Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 months post intervention
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale
Time frame: Baseline
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale
Time frame: 3 months post intervention
Anxiety as Measured by Generalized Anxiety Disorder (GAD) Scale
Time frame: 6 months post intervention
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress
Time frame: Baseline
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)
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress
Time frame: 3 months post intervention
Distress as Measured by PROMIS Item Bank v.1.0-Emotional Distress
Time frame: 6 months post intervention
Risk Seeking as Measured by Risk Propensity Scale.
Time frame: Baseline
Risk Seeking as Measured by Risk Propensity Scale.
Time frame: immediately after completing the intervention (about 2 to 4 weeks after baseline)
Risk Seeking as Measured by Risk Propensity Scale.
Time frame: 3 months post intervention
Risk Seeking as Measured by Risk Propensity Scale.
Time frame: 6 months post intervention
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)
Time frame: Baseline
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 Amsterdam Executive Function Inventory (AEFI)
Time frame: 3 months post intervention
Executive Function as Measured by the Amsterdam Executive Function Inventory (AEFI)
Time frame: 6 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored MBI (.b) in people with Stress, Emotional, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation as Measured by Difficulties in Emotion Regulation Scale (DERS) (time frame: Baseline). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.