Recruiting
Phase 2

Observational Study

Sponsor:

UCLA

Code:

NCT05611060

Conditions

Adverse Childhood Experiences

Housing Problems

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Building Healthy Life Skills Program

Study Details

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.

Conditions

Adverse Childhood Experiences

Housing Problems

Emotion Regulation

Study ID

NCT05611060

Start date

Oct 10, 2022

Status verified date

Nov, 2022

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Building Healthy Life Skills Program

The intervention provides education and training in the long-term mental and physical health consequences of childhood adversity and emotion regulation skills.

Primary outcome 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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) [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]
  • 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 [ Time Frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion ]

Central Contacts and Locations

Central contacts

Locations

University of California Merced

Recruiting

Merced, California, United States, 95343

Contacts

Marisela Yepez, B.A.

myepez5@ucmerced.edu

More Information

Sponsor

University of California, Merced

Last update posted

Nov 9, 2022

Last verified

Nov, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Merced on 2022-11-09.