Clinical trial NCT05611060: Evaluation of the Building Healthy Life Skills Program
Official title: Building Healthy Life Skills for Merced County Navigation Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adverse Childhood Experiences
Housing Problems
Emotion Regulation
Lead sponsor: University of California, Merced
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study utilizes a pretest-posttest design, with surveys completed at baseline immediately prior to the start of the intervention onset, immediately after completion of the intervention, and at follow-up 3 months after the completion of the intervention.
Primary purpose: TREATMENT

Brief summary: The goal of this intervention trial is to learn test whether participation in the Building Health Life Skills Program leads to improvements in psychological well-being and stress management skills for people who are experiencing homelessness and housing insecurity. The main questions it aims to answer are:

* Will participation in the Building Healthy Life Skills Program lead to better skills in managing negative emotions?
* Will participation in the Building Healthy Life Skills Program lead to improvements in psychological well-being, sleep quality, and health-related quality of life?

Participants will be asked to complete three surveys: one prior to the first session of the program, one at the end of the program, and one three months later. The surveys include measures of skills for managing negative emotions, mood states, sleep quality, health-related quality of life, illness experiences, and history of childhood adversity.

Detailed description: Community members who are experiencing homelessness and receiving support services from the Merced County Navigation Center and who have enrolled in the center's Building Healthy Life Skills Program will be invited to participate in this intervention evaluation study. The Building Healthy Life Skills program is a 10-week program designed to provide participants with an understanding of how abuse, neglect and household dysfunctions during childhood affect emotional, social, and cognitive well-being; and to provide training in emotion regulation skills, including adaptive emotional processing and expression, mindfulness, and cognitive reappraisal. The sessions are two hours in duration and conducted in classroom style. Open enrollment will be conducted four times a year, serving approximately 60 individuals.

Eligibility criteria: Inclusion Criteria:

* Individuals who are receiving support services from the Merced County Navigation Center due their current experiences of housing insecurity or homelessness, and
* have enrolled in the Building Healthy Life Skills program

Exclusion Criteria:

* Individuals under the age of 18 years and those who cannot speak English or Spanish

Primary outcomes:
measure: Change in health-related quality of life as assessed by the SF-12, for which scores range from 0 to 100 with higher scores reflecting better quality of life
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in depressive symptoms as assessed by the Center for Epidemiological Studies Depression measure, for which averaged rating scores range from 0 to 3 with higher scores reflecting more depressive symptoms
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in stress as assessed by the Perceived Stress Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater stress
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in rumination as an emotion regulation behavior as assessed by the Rumination and Reflections Questionnaire,for which averaged rating scores range from 1 to t with higher scores reflecting more rumination
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in emotional suppression as assessed by the Cortauld Emotional Control Scale (scores range is 1-4, higher scores reflect higher suppression) and the Emotion Regulation Questionnaire (scores range is 1-5, higher scores reflect higher suppression)
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in mindfulness as an emotional regulation tendency as assessed by the Mindful Awareness Attention Scale, for which averaged rating scores range from 1 to 5 with higher scores reflecting greater mindfulness tendencies
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in cognitive reappraisal as an emotion regulation strategy as assessed by the Emotion Regulation Questionnaire, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher use of cognitive reappraisal
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in general self-efficacy as assessed by the General Self-Efficacy Survey, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher sense of self-efficacy in managing challenging situations
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in resilience as assessed by the Ego Resilience 89, for which averaged rating scores range from 1 to 5 with higher scores reflecting higher resilience in managing challenging situations
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in sleep quality as assessed by the Pittsburgh Sleep Quality Inventory, for which averaged rating scores range from 0 to 21 with higher scores reflecting poorer sleep quality
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
measure: Change in physical health as assessed by self-reported number of sick days in the past month (ranging from 0 to 31) and a the frequency of 17 symptoms each rated 1 to 5 and higher averaged rating scores reflecting higher symptom loads
timeFrame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Merced
country: United States
facility: University of California Merced
state: California
Study officials:
References: