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

A Mindfulness-Based Intervention (MBI), called ".b," will be tailored to Youth Experiencing Homelessness (YEH) by using focus group discussions, key informant interviews, and iterative beta-testing with the Homeless Youth Working Group (HYWG). The purpose of this study is to assess the feasibility and acceptability of this tailored MBI in YEH (the tailored MBI called .b will be compared to an attention control condition). The results of this feasibility study will inform the design of a future randomized controlled trial that will aim to test the efficacy of the intervention for improving stress management, increasing emotional regulation, decreasing impulsivity in YEH.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Emotional
• Intervention / Treatment: Behavioral: tailored MBI (.b); Behavioral: attention control condition

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Diane M Santa Maria, DrPH,MSN,FAANRN,PHNA-BC,FSAHM,; Phone Number: (713) 500-2002; Email: Diane.M.SantaMaria@uth.tmc.edu

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 for Youth Participants:

• 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)

Inclusion Criteria for Service Providers:

• currently providing health or social services to YEH
• interested in participating in an interview or as a member of the Expert Advisory Panel

Exclusion Criteria for Youth Participants:

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

Exclusion Criteria for Service Providers:

-not able to meet for the regularly scheduled meetings at least 75% of the time.

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
Change in 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) ,higher score indicates greater problem with emotion regulation	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in 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) ,higher score indicates higher levels of mindfulness	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in 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 (1day after baseline),3 months post intervention,6 months post intervention
Change in Self-Compassion as measured by Self-Compassion Scale (SCS)	The SCS is a 26 item questionnaire and each item is scored from 1(almost never)-5 (almost always) ,higher score indicates -------	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in 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),higher score indicating a higher perceived stress.	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Connectedness as measured Social Connectedness Scale	The scale is a 20 item questionnaire and each item is scored from 1(strongly disagree)-6(strongly agree),higher score indicating more connectedness to others.	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in 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
Change in 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
Change in 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 (items1, 3, 5, 9, 10, 12, 14, 16, 17, and 19) score ranges for 10-50 with higher scores indicating higher levels of positive effect.Negative affect ( items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20) score ranges form 10-50, with lower scores indicating lower levels of negative effect.	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in Vulnerability as measured by Psychological Vulnerability Scale	This is a 6 item questionnaire,each item is measured from 1(does not describe me at all)-5 describes me very well.A higher score indicates more vulnerability.	Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Change in 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
Change in 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 (1day after baseline),3 months post intervention,6 months post intervention

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 (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 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): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SN-20-0466; 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