CClinicalTrials.gg
Status unknownNCT05611060Updated Nov 9, 2022

Evaluation of the Building Healthy Life Skills Program

A Phase 2 interventional study of Building Healthy Life Skills Program in Adverse Childhood Experiences, Housing Problems and Emotion Regulation, sponsored by University of California, Merced. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by University of California, Merced · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adverse Childhood Experiences
  • Housing Problems
  • Emotion Regulation
03

In context

Lead sponsor

University of California, Merced is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Individuals under the age of 18 years and those who cannot speak English or Spanish
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • BehavioralBuilding 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.

06

What researchers measure

Primary outcomes

  1. 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

    Health-related quality of life as assessed by the SF 12

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  2. 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

    Scores on the Center for Epidemiological Studies Depression measure

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  3. 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

    Scores on the Perceived Stress Scale

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  4. 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

    Scores on the Rumination and Reflections Questionnaire

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  5. 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)

    Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  6. 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

    Scores on the Mindful Awareness Attention Scale

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  7. 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

    Scores on the Emotion Regulation Questionnaire

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  8. 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

    Scores on the General Self-Efficacy Survey

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  9. 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

    Scores on the Ego Resilience 89

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  10. 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

    Scores on the Pittsburgh Sleep Quality Inventory

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

  11. 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

    Scores on a symptom checklist and number of sick days

    Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion

07

Study locations

1 of 1 sites recruiting
  • University of California Merced
    Merced, California 95343, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — We have not decided on the IPD sharing plan at this point in time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05611060
Lead sponsor
University of California, Merced
Responsible party
Linda Diane Cameron (Professor, University of California, Merced) — Principal investigator
First posted
Nov 9, 2022
Start date
Oct 10, 2022
Primary completion
Jul 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Nov 9, 2022

Study contacts

Linda D Cameron, Ph.D.
Contact
lcameron@ucmerced.edu
209-626-6892
Marisela Yepez, B.S.
Contact
myepez5@ucmerced.edu
209-228-2252

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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