Early Life AdversityCARENCT05259436
Collaborative Approach to Examining Adversity and Building Resilience Study
A study testing Caregiver-child Intervention 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
To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Life Adversity, Caregiver Stress
- What is being tested?
- Caregiver-child Intervention 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
- 300 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Apr 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)
- Attachment and Biobehavioral Catch-up (ABC) Program
- Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
- Child: 2 to 4 years, PEARLS score > 1
- Resilience Clinic
- Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
Show all 10Show fewer
- Child: 2 to 5 years, PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
- HEROES Family Program
- Caregiver: 18 years old and older, primary caregiver, ACE score > 2 if child PEARLS score = 0, English or Spanish speaking
- Child: 2 to 5 years, PEARLS score > 1
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
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
LifeLong Medical Care
Richmond, California, 94804
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Santa Barbara Neighborhood Clinics
Santa Barbara, California, 93101
About this study
To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.
Read the detailed description
Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.
Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.
- Conditions
- Early Life Adversity, Caregiver Stress
- Being tested
- Caregiver-child Intervention, Enhanced Primary Care
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver-child InterventionBehavioural
Intervention Groups:
- Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness;
- ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity; and,
- Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres.
Enhanced Primary CareBehavioural
Enhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-Child Intervention | Experimental | Investigators will examine the immediate psychosocial, behavioral, and child biologic response to three caregiver-child interventions depending on site of enrollment. Each interventions contain overlapping core elements, but also contribute unique facets, allowing us to examine overall intervention effects, as well as unique settings (e.g. home vs. clinic) and delivery effects (1:1 vs. group), providing insight for future direction. Receives: Behavioral: Caregiver-child Intervention |
| Enhanced Primary Care | Active comparator | Navigational services for social need resources. 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 (PSI) score
Caregiver reported survey validated measure of parenting stress. The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. 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) total problems scale score
Caregiver reported survey validated measure of child behavioral and emotional challenges on the Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary outcomes (19)
Change in global health (PROMIS global health)
PROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. This study uses the first question on the global scale, with minimum value of 1 and maximum of 5. Higher scores mean better general health.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in caregiver depression (PHQ) total score
Caregiver reported survey validated measure of self-report depressive symptoms on the Patient Health Questionnaire (PHQ). Respondents are asked 8 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-27. Higher scores indicate higher self-report depressive symptoms.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in caregiver anxiety (GAD) total score
Caregiver reported survey validated measure of self-report symptoms of general anxiety on the General Anxiety Disorder (GAD) questionnaire. Respondents are asked 7 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-21. Higher score indicates higher self-report general anxiety symptoms.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in family cohesion total score
The Family Adaptability and Cohesion Evaluation Scales II (FACES II) family cohesion scale evaluates eight concepts (2 items each): emotional bonding, family boundaries, coalitions, time, space, friends, decision-making, and interest and recreation. Respondents rate from 1 for "almost never or never" to 5 for "almost always or always." A higher score indicates high family cohesion.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in adult reported social and emotional support (ARSES) total score
Adult-reported social and emotional support is assessed using a standardized single item, "How often do you get the social and emotional support you need?" Response choices were "always," "usually," "sometimes," "rarely," or "never."
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in atopy (ISSAC screen)
ISAAC was an epidemiological study following a survey of 2 million children worldwide to evaluate the prevalence of atopic disease in various ethnic backgrounds. The questionnaire is self-reported by parents and children to evaluate asthma, allergic rhinitis and eczema in childhood. 21 items, core questionnaires to assess the prevalence and severity of asthma, rhinitis and eczema in defined populations.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in general stress (Perceived Stress Scale) total score
The Perceived Stress Scale measures the extent to which an individual perceives situations in his or her life as stressful. It is a measure of global perceived stress and asks about feelings and thoughts during the last month. Respondents are asked 10 questions to rate from 0 for "never" to 4 for "very often" based on the past month. The range of possible values is from 0-40. Higher score indicates higher perceived stress.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in health-related social needs (Accountable Health Communities total score)
Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.
Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.
Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.
Measured: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Telomere length
Telomeres are nucleoproteins that protect the ends of chromosomes. Telomere length is a biomarker of cellular aging. Chronic stress has been associated with shorter telomere length.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
Leptin
Leptin is a hormone primarily secreted by fat cells to reduce hunger.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
CRP
C-reactive protein is produced by the liver in response to inflammation. Higher level of CRP in the blood is an indicator of inflammation.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
IGFBP1
Insulin-like growth factor binding protein 1 is mainly expressed in the liver and circulates in plasma where it interacts with IGF-1 and 2. IGFBP-1 plays an important role in metabolism and low levels of this protein has associated with impaired glucose tolerance and hypertension
Measured: baseline/enrollment and 3-month follow-up after intervention ends
HA1C
The hemoglobin A1c (glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to evaluate a person's level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
blood pressure
Systolic and diastolic blood pressure, averaged across 3 readings.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
resting heart rate
Number of beats per minutes.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
waist circumference
Measuring waist circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
hip circumference
Measuring hip circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.
Measured: baseline/enrollment and 3-month follow-up after intervention ends
weight
Weight will be measured in kg. Weight and height will be combined to report BMI in kg/m^2
Measured: baseline/enrollment and 3-month follow-up after intervention ends
height
Height will be measured in cm. Weight and height will be combined to report BMI in kg/m^2
Measured: baseline/enrollment and 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 posted28 Feb 2022
- Study start11 Apr 2022
- Primary completion31 Dec 2024
- Study completion30 Jun 2025 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wait-list randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Lifelong Medical Care, UCSF Benioff Children's Hospital Oakland, Santa Barbara Neighborhood Clinics, University of California, Santa Barbara, Futures Without Violence
- Responsible party
- Sponsor
- Investigators
- Neeta Thakur, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259436
- Sponsor's protocol ID
- 21-34534
- Acronym
- CARE
- Status last verified
- May 2025
- First submitted
- 7 Feb 2022
- Last updated
- 8 May 2025
- Results posted
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Approach to Examining Adversity and Building Resilience Study
- ClinicalTrials.gov ID
- NCT05259436
- Acronym / sponsor ID
- CARE / 21-34534
- Conditions
- Early Life Adversity, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Lifelong Medical Care, UCSF Benioff Children's Hospital Oakland, Santa Barbara Neighborhood Clinics, University of California, Santa Barbara, Futures Without Violence
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Feb 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.
To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.
Detailed description
Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.
Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Wait-list randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Caregiver-Child Intervention | Experimental | Behavioral: Caregiver-child InterventionInvestigators will examine the immediate psychosocial, behavioral, and child biologic response to three caregiver-child interventions depending on site of enrollment. Each interventions contain overlapping core elements, but also contribute unique facets, allowing us to examine overall intervention effects, as well as unique settings (e.g. home vs. clinic) and delivery effects (1:1 vs. group), providing insight for future direction. |
| Enhanced Primary Care | Active comparator | Behavioral: Enhanced Primary CareNavigational services for social need resources. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)
- Attachment and Biobehavioral Catch-up (ABC) Program
- Resilience Clinic
- HEROES Family Program
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 |
|---|---|---|
| Caregiver-child InterventionIntervention Groups: 1. Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness; 2. ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity; and, 3. Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres. | Behavioural | Caregiver-Child Intervention |
| Enhanced Primary CareEnhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources. | Behavioural | Enhanced Primary Care |
Primary outcome
Change in Parenting Stress Index (PSI) score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver reported survey validated measure of parenting stress. The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate higher levels of parenting stress.
Change in Child Behavior Checklist (CBCL) total problems scale score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Caregiver reported survey validated measure of child behavioral and emotional challenges on the Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100.
19 secondary outcomes
Change in global health (PROMIS global health)
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in caregiver depression (PHQ) total score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in caregiver anxiety (GAD) total score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in family cohesion total score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in adult reported social and emotional support (ARSES) total score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in atopy (ISSAC screen)
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in general stress (Perceived Stress Scale) total score
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Change in health-related social needs (Accountable Health Communities total score)
Time frame: baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Telomere length
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
Leptin
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
CRP
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
IGFBP1
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
HA1C
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
blood pressure
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
resting heart rate
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
waist circumference
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
hip circumference
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
weight
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
height
Time frame: baseline/enrollment and 3-month follow-up after intervention ends
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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.
Neeta Thakur, MD, MPH 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 Caregiver-child Intervention 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 10 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: under way, not looking for participants, as of the sponsor's last update on 8 May 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?
This study is still under way. Results are not available in the source record yet.
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 (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 8 May 2025.