Adverse Childhood ExperiencesPhase 2NCT05611060
Evaluation of the Building Healthy Life Skills Program
A Phase 2 study testing Building Healthy Life Skills Program in people with Adverse Childhood Experiences and Housing Problems, run by University of California, Merced at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences, Housing Problems, Emotion Regulation
- What is being tested?
- Building Healthy Life Skills Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals under the age of 18 years and those who cannot speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California Merced
Merced, California, 95343
Linda D Cameron, Ph.D., 209-626-6892, lcameron@ucmerced.edu
Marisela Yepez, B.A., myepez5@ucmerced.edu
About this study
Official title: Building Healthy Life Skills for Merced County Navigation Center
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.
- Being tested
- Building Healthy Life Skills Program
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Healthy Life Skills ProgramBehavioural
The intervention provides education and training in the long-term mental and physical health consequences of childhood adversity and emotion regulation skills.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Scores on the Center for Epidemiological Studies Depression measure
Measured: 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
Scores on the Perceived Stress Scale
Measured: 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
Scores on the Rumination and Reflections Questionnaire
Measured: 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)
Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire
Measured: 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
Scores on the Mindful Awareness Attention Scale
Measured: 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
Scores on the Emotion Regulation Questionnaire
Measured: 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
Scores on the General Self-Efficacy Survey
Measured: 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
Scores on the Ego Resilience 89
Measured: 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
Scores on the Pittsburgh Sleep Quality Inventory
Measured: 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
Scores on a symptom checklist and number of sick days
Measured: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start10 Oct 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Merced
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Diane Cameron, University of California, Merced
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611060
- Sponsor's protocol ID
- Cameron2022
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided on the IPD sharing plan at this point in time.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Healthy Life Skills for Merced County Navigation Center
- ClinicalTrials.gov ID
- NCT05611060
- Acronym / sponsor ID
- Cameron2022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, MercedUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals under the age of 18 years and those who cannot speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Healthy Life Skills ProgramThe intervention provides education and training in the long-term mental and physical health consequences of childhood adversity and emotion regulation skills. | Behavioural | – |
Primary outcome
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
Health-related quality of life as assessed by the SF 12
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
Scores on the Center for Epidemiological Studies Depression 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
Time frame: Assessed at baseline, immediately following completion of the intervention, and 3 months following intervention completion
Scores on the Perceived Stress Scale
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
Scores on the Rumination and Reflections Questionnaire
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
Scores on the Cortauld Emotional Control Scale and the Emotion Regulation Questionnaire
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
Scores on the Mindful Awareness Attention Scale
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
Scores on the Emotion Regulation Questionnaire
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
Scores on the General Self-Efficacy Survey
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
Scores on the Ego Resilience 89
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
Scores on the Pittsburgh Sleep Quality Inventory
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
Scores on a symptom checklist and number of sick days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: Undecided. We have not decided on the IPD sharing plan at this point in time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Building Healthy Life Skills Program in people with Adverse Childhood Experiences and Housing Problems, run by University of California, Merced at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda D Cameron, Ph.D. (209-626-6892, lcameron@ucmerced.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.