Early Life AdversityNCT05690256
The Resilience Clinic Evaluation
A study testing Resilience Clinic and Enhanced primary care in people with Early Life Adversity and Caregiver Stress, run by University of California, San Francisco at 4 sites in United States.
Trial summary
Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Life Adversity, Caregiver Stress
- What is being tested?
- Resilience Clinic and Enhanced primary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 May 2023to 30 Jun 2025
- Phase
- Interventional
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
- Child: 2 to 5 years, PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
Who cannot join
- Caregiver: active suicidality, other psychiatric issues
- Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
La Clinica de la Raza
Oakland, California, 94601
Asian Health Services
Oakland, California, 94607
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
UBCP-Bancroft Pediatrics
San Leandro, California, 94577
About this study
Official title: The Resilience Clinic: Program Evaluation and Quality Improvement
Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.
Read the detailed description
Early-life trauma and related adversities are prevalent and associated with negative health, developmental, and behavioral outcomes in children. Research to design and test practical, scalable healthcare interventions that mitigate toxic stress is needed to promote improved health and developmental outcomes in children.
The Resilience Clinic is an interactive, caregiver-child psychoeducational intervention for parents and other adult caregivers of young children (ages 0-5 years) with exposure to traumatic events or other significant adversity. The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face of adversity, with the goal of improving child health, behavioral, and developmental outcomes.
The overall aim of this study is to evaluate the the efficacy and operational feasibility of the revised Resilience Clinic (RC). This is a non-randomized clinical trial comparing intervention caregiver-child dyads to a prospective control group drawn from a concurrent clinical trial (NCT05259436, The Collaborative Approach to Examining Adversity and Building Resilience Study (CARE), PI Thakur). In the intervention group, we will conduct pre-post intervention comparisons along with comparisons between the intervention group and the control group drawn from the CARE study. A subgroup analysis will compare two intervention arms (clinic based vs community-based intervention) to each other and the control condition. This clinical trial is supplemented by a mixed-methods quality improvement (QI) tools, including process measures (attendance and billing/claims data) to evaluate operational and financial feasibility; participant surveys/interviews/focus groups to assess acceptability; and analysis of quality improvement meeting notes.
- Conditions
- Early Life Adversity, Caregiver Stress
- Being tested
- Resilience Clinic, Enhanced primary care
- Keywords
- toxic stress, adverse childhood experiences
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience ClinicBehavioural
A psychoeducational caregiver-child intervention based in primary care, designed to mitigate toxic stress and promote child resilience. Participants engage in 6 weekly visits in primary care using an interactive curriculum based in the evidence-based Circle of Security Parenting along with mindfulness principles.
Enhanced primary careBehavioural
In addition to usual pediatric primary care, enhanced primary care (the control condition for this study) provides navigational services to link to community resources based on screening for unmet social needs (e.g., food insecurity, housing, financial strain).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Resilience Clinic Receives: Behavioral: Resilience Clinic |
| Control | Active comparator | Enhanced pediatric primary care Receives: Behavioral: Enhanced primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parenting Stress Index Short Form (PSI) score
36-item caregiver-report questionnaire validated as a measure of parenting stress (level of stress within the context of parenting). Responses indicated on a 5-point Likert scale. Higher scores indicate higher levels of parenting stress.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score
Caregiver-report questionnaire validated as a measure of child behavioral challenges; part of the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL-Preschool form is validated for children ages 1.5-5 years based on behavior from the prior 2 months.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary outcomes (7)
Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score
Caregiver-report questionnaire, validated as a measure of executive functioning in preschool aged children (ages 2-5:11)
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
PROMIS is a set of person-centered measure evaluating the physical, mental, and social health of adults and children. This study uses the first question on the global scale, with a minimum value of 1 and maximum of 5; higher scores indicate better general health.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores
Caregiver-report questionnaire validated as a measure for risk of developmental delay in children ages 0-60 months.
Measured: baseline/enrollment to 3 month follow-up after intervention ends
Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale
Questionnaire validated as a measure of depressive symptoms; higher scores indicate higher self-report depressive symptoms. Will be given to questionnaires to assess their depressive symptoms.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Caregiver anxiety score on the Generalized Anxiety Disorder (GAD) scale
Questionnaire validated as a measure of anxiety symptoms; high scores indicate higher levels of anxiety. Will be given to caregivers to assess their anxiety symptoms.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Perceived Stress Scale (PSS) total score- Caregiver general stress
Self-report questionnaire that measures global perceived stress based on feelings and thoughts during the last month. Higher scores indicate higher perceived stress. Will be given to caregivers as a measure of their general perceived stress.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in telomere length (children)
Telomere are nucleoproteins that protect the ends of chromosomes and can be used as a biomarker of cellular aging. Chronic stress has been associated with shorter telomere length. DNA will be extracted from cheek cells (obtained by buccal swab) in children.
Measured: baseline/enrollment to 3 month follow-up after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start25 May 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Life AdversityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized controlled trial (prospective cohort study)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Innovation Lab, UCSF Benioff Children's Hospital Oakland, UBCP Bancroft Pediatrics, Asian Health Services, La Clínica de La Raza Inc.
- Responsible party
- Sponsor
- Investigators
- Joan Jeung, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690256
- Sponsor's protocol ID
- 22-37781
- Status last verified
- Jul 2025
- First submitted
- 29 Dec 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Resilience Clinic: Program Evaluation and Quality Improvement
- ClinicalTrials.gov ID
- NCT05690256
- Acronym / sponsor ID
- 22-37781
- Conditions
- Early Life Adversity, Caregiver Stress
- Keywords
- toxic stress, adverse childhood experiences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Population Health Innovation Lab, UCSF Benioff Children's Hospital Oakland, UBCP Bancroft Pediatrics, Asian Health Services, La Clínica de La Raza Inc.
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Jan 2023 (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.
Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.
Detailed description
Early-life trauma and related adversities are prevalent and associated with negative health, developmental, and behavioral outcomes in children. Research to design and test practical, scalable healthcare interventions that mitigate toxic stress is needed to promote improved health and developmental outcomes in children.
The Resilience Clinic is an interactive, caregiver-child psychoeducational intervention for parents and other adult caregivers of young children (ages 0-5 years) with exposure to traumatic events or other significant adversity. The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face of adversity, with the goal of improving child health, behavioral, and developmental outcomes.
The overall aim of this study is to evaluate the the efficacy and operational feasibility of the revised Resilience Clinic (RC). This is a non-randomized clinical trial comparing intervention caregiver-child dyads to a prospective control group drawn from a concurrent clinical trial (NCT05259436, The Collaborative Approach to Examining Adversity and Building Resilience Study (CARE), PI Thakur). In the intervention group, we will conduct pre-post intervention comparisons along with comparisons between the intervention group and the control group drawn from the CARE study. A subgroup analysis will compare two intervention arms (clinic based vs community-based intervention) to each other and the control condition. This clinical trial is supplemented by a mixed-methods quality improvement (QI) tools, including process measures (attendance and billing/claims data) to evaluate operational and financial feasibility; participant surveys/interviews/focus groups to assess acceptability; and analysis of quality improvement meeting notes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- non-randomized controlled trial (prospective cohort study)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Resilience ClinicResilience Clinic |
| Control | Active comparator | Behavioral: Enhanced primary careEnhanced pediatric primary care |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
- Child: 2 to 5 years, PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
Key exclusion criteria (2 listed)
- Caregiver: active suicidality, other psychiatric issues
- Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
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 |
|---|---|---|
| Resilience ClinicA psychoeducational caregiver-child intervention based in primary care, designed to mitigate toxic stress and promote child resilience. Participants engage in 6 weekly visits in primary care using an interactive curriculum based in the evidence-based Circle of Security Parenting along with mindfulness principles. | Behavioural | Intervention |
| Enhanced primary careIn addition to usual pediatric primary care, enhanced primary care (the control condition for this study) provides navigational services to link to community resources based on screening for unmet social needs (e.g., food insecurity, housing, financial strain). | Behavioural | Control |
Primary outcome
Change in Parenting Stress Index Short Form (PSI) score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
36-item caregiver-report questionnaire validated as a measure of parenting stress (level of stress within the context of parenting). Responses indicated on a 5-point Likert scale. Higher scores indicate higher levels of parenting stress.
Change in Child Behavior Checklist (CBCL)-Preschool form total problems scale score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver-report questionnaire validated as a measure of child behavioral challenges; part of the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL-Preschool form is validated for children ages 1.5-5 years based on behavior from the prior 2 months.
7 secondary outcomes
Change in Behavior Rating Inventory of Executive Function, Preschool Version (BRIEF-P) score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) global health score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Ages and Stages Questionnaire (ASQ)-3rd Edition scores
Time frame: baseline/enrollment to 3 month follow-up after intervention ends
Change in Caregiver depression score on the Patient Health Questionnaire (PHQ)-8 scale
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Caregiver anxiety score on the Generalized Anxiety Disorder (GAD) scale
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in Perceived Stress Scale (PSS) total score- Caregiver general stress
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in telomere length (children)
Time frame: baseline/enrollment to 3 month follow-up after intervention ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Joan Jeung, MD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Clinic and Enhanced primary care in people with Early Life Adversity and Caregiver Stress, run by University of California, San Francisco at 4 sites 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 2 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: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parenting Stress Index Short Form (PSI) score (time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends). The study lists 2 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 10 Jul 2025.