Clinical trial NCT04950816: Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress, Emotional
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-07-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Emotion Regulation as measured by Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Mindfulness as measured by Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Mindfulness as measured by Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Self-Compassion as measured by Self-Compassion Scale (SCS)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Stress as measured by Perceived Stress Scale (PSS)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Secondary outcomes:
measure: Change in Social Connectedness as measured Social Connectedness Scale
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Depression as measured by Short Mood and Feelings Questionnaire (SMFQ)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Anxiety as measured by Spielberger State-Trait Anxiety Inventory
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Affect as measured by Positive and Negative Affect Scale (PANAS-SF)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Vulnerability as measured by Psychological Vulnerability Scale
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Distress as measured by Kessler Psychological Distress Scale (K10)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
measure: Change in Risk Seeking as measured by Balloon Analogue Risk Task (BART)
timeFrame: Baseline, immediately after intervention (1day after baseline),3 months post intervention,6 months post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Diane M Santa Maria, DrPH,MSN,RN,PHNA-BC,FSAHM,FAAN
role: PRINCIPAL_INVESTIGATOR
References: