Health ServicesCARENCT07686614
Telephone-Based Care Coordination for Services Addressing Childhood Adversity
A study testing Telephone-based Screening and Care Coordination in people with Health Services and Mental Health, run by Paul Chung at 1 site in United States.
Trial summary
The goal of this study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are: 1. Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services? 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Services, Mental Health, Well-being
- What is being tested?
- Telephone-based Screening and Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 31 Mar 2030
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent or legal guardian of focal child
- Comfortable completing surveys in English or Spanish
- Focal child is less than 12 years of age at enrollment
Who cannot join
- Focal child participated in the 'UCANN" pilot study
- Focal child's sibling is enrolled in this study
- Focal child is currently assigned a DCFS (Department of Child and Family Services) case worker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente School of Medicine
Pasadena, California, 91101
About this study
The goal of this study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are:
- Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services?
- Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing?
- Does telephone-based screening and care coordination for children experiencing ACEs improve child social and emotional health?
Read more
Researchers will compare families who have been randomly selected to receive telephone-based screening and care coordination with those who will receive usual care at their clinic.
Participants will:
- Be randomly assigned to receive usual care or usual care plus telephone-based screening and care coordination (the intervention)
- If selected for the intervention, be connected to 211 Los Angeles to receive screening and care coordination for up to 6 months
- Complete four surveys via interview; surveys will be done at enrollment and 1 month, 6 months, and 12 months following enrollment
- Agree to allow researchers to review their child's medical records to collect information about their child's health, screenings, diagnoses, and referrals.
Read the detailed description
Throughout the recruitment period, clinic partners will send an opt-out letter or text message to all families with an upcoming well-child visit in the next month, providing instructions for how families can opt out of study recruitment efforts. Those who do not opt out may be contacted by phone by the study team. Potential participants will be selected for contact from a clinic's appointment list utilizing a random number generator roughly one month prior to their scheduled well-child visit to invite them to participate. Invitations will continue until weekly quotas for enrollment are met. Upon contacting the family, the study team Research Associate will screen for eligibility and explain the study.
If the child is eligible and the family is interested in participating, the RA will obtain electronic parent permission and consent for study participation and electronic HIPAA authorization for research for the study team to obtain information from the medical chart.
Following the consent process, the research team will administer the baseline survey over the phone. The survey will include socio-demographic characteristics as well as measures for family functioning and material resources and parent and child health and wellbeing.
Following baseline survey completion, children will be individually randomized to the intervention or control group. Randomization will be stratified by clinic system to ensure even representation across intervention and control groups in each clinic system. To determine group assignment, the RA will enter the clinic in REDCap, which will reveal the assigned group (intervention or control) using a permuted block randomization list generated by the statistician. The RA will provide the participant with their group assignment at this time as well as briefly describe the intervention further for the intervention group.
After randomization is complete, those in the intervention group will be connected to 211 LA via warm transfer phone call or by providing the family's contact information to 211 LA. Once connected to the parent, the 211 LA Care Coordination specialist will conduct ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, 211 LA will provide information about and connection to relevant evaluations and services, with specific attention to mental health, child development, and material needs and services. The care coordinator specialist will stay in touch with the family (contacting families 1 or 2 times per month based on coordinator-assessed need) for up to 6 months, until the parent wishes to discontinue contact, or the child is enrolled in all desired services. Families are encouraged to call 211 LA with additional questions or concerns.
Both intervention and control group families will receive usual well-child care and ACEs screening using the PEARLS in the clinic. Providers will provide referrals and care coordination per their current practices and will be blinded as to study group assignment during the intervention.
In addition to the baseline survey, participants will be contacted by the research team via phone roughly 1 month following enrollment to learn about any initial referrals the family received through either the clinic or 211 LA. In addition, parents will be asked to complete a follow-up survey over the phone at 6 and 12 months following enrollment, for a total of four surveys. After completion of each survey, parents will receive a monetary incentive to compensate them for their time.
The study team will also obtain intervention group data from 211 LA regarding ACEs screening results, referrals, and referral outcomes. Finally, the study team will review charts 6 months after enrollment for both intervention and control groups regarding clinic-based ACEs screening results, referrals, and services.
Study data will be collected and managed using REDCap (Research Electronic Data Capture), a secure web application designed to support data capture for research studies, providing web-based case report forms, real-time data entry validation, audit trails, and a de-identified data export to common statistical packages.
- Conditions
- Health Services, Mental Health, Well-being
- Being tested
- Telephone-based Screening and Care Coordination
- Keywords
- child health, adverse childhood experiences, care coordination, parent health, parent mental health, child mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based Screening and Care CoordinationBehavioural
Once connected to the parent, the 211 LA Care Coordination specialist will administer ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, 211 LA will provide information about and connection to relevant evaluations and services, with specific attention to mental health, child development, and material needs and services. The care coordinator specialist will stay in touch with the family (contacting families 1 or 2 times per month based on coordinator-assessed need) for up to 6 months, until the parent wishes to discontinue contact or the child is enrolled in all desired services.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Receipt of usual well child care and ACEs screening using the PEARLS in the clinic. Participants may receive referrals and care coordination per their clinic's current practices. |
| Intervention + Usual Care | Experimental | A Care Coordination specialist will conduct ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, the specialist will recommend and provide information about and connection to relevant evaluations and services.
Participants will continue to receive usual well child care and ACEs screening using the PEARLS in the clinic. Participants may receive referrals and care coordination per their clinic's current practices. Receives: Behavioral: Telephone-based Screening and Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of ACEs-related services
Assessed by whether a child receives an ACEs-related service by 6 months (i.e., at least 1 specific service appointment made and kept, per parent report).
We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Measured: Between baseline and follow-up surveys 6-9 months after baseline
Parent health and Wellbeing: Global Physical Health
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales.
Global Physical Health subscale score (calculated from 4 items), T-score range 16.2-67.7, higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Parent Health and Wellbeing - Global Mental Health
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales. Global Mental Health subscale score (calculated from 4 items), T score range 21.2-67.6, higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Child social-emotional wellbeing, under the age of 3
This outcome will be assessed by Ages and Stages Questionnaire: Social-Emotional, 2nd Edition (ASQ:SE) for children under age 3, which assesses children's social-emotional health across domains of self-regulation, compliance, social-communication, adaptive functioning, autonomy, affect, and interaction with people. Range is 0-525 (for the 36 month questionnaire); higher score indicates worse outcome. We will compare the 12-month outcome scores (ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Child Social-Emotional Wellbeing, ages 3 and older
This outcome will be assessed by the Strengths and Difficulties Questionnaire (SDQ) for children 3 years and older, which assesses children's wellbeing across domains of emotional, conduct, hyperactivity/inattention, and peer problems, as well as prosocial behavior. Total Difficulties Score Range is 0-40 with higher score indicating worse outcome. We will compare the 12-month outcome scores (SDQ Total Difficulties Score and ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Secondary outcomes (14)
Receipt of ACEs-related referrals
Assessed by whether a child is referred to an ACEs-related service evaluation by 6 months (i.e., at least 1 referral for a specific service, per parent report).
We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Measured: Between baseline and follow-up surveys 6-9 months after baseline
Number of ACEs-related referrals per family
Assessed by the numbers of referrals made each family. We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Measured: By the time of the 6-9 month and 12-15 month follow-up surveys
Number of ACEs-related services received per family
This outcome will be assessed by the numbers of services received for each family. We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Measured: By the time of the 6-9 month and 12-15 month follow-up surveys
Parent Emotional Wellbeing: Psychological Distress
This outcome will be assessed by the Kessler-6 Psychological Distress Scale, which is a brief screening scale that measures non-specific psychological distress. Range is 0-24; higher score indicates worse outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Parent Emotional Wellbeing: Perceived Stress
This outcome will be assessed by the Perceived Stress Scale measures the degree to which situations in one's life are appraised as stressful. Range is 0-40; higher score indicates worse outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Parent Emotional Wellbeing: Parental Stress
This outcome will be assessed by the Parental Stress Scale, which measures the levels of stress experienced by parents. Range is 18-90, higher score indicates worse outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: Attendance
Number of missed days in the previous school year that school/preschool/daycare was in session
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Readiness, Ages 2-3 years 11 months
This outcome will be assessed in participants ages 2-3 years 11 months old using the Ages and Stages Questionnaire: Social-Emotional, 2nd Edition (ASQ:SE) for 24, 30, 36 and 48 months. Range is 0-576 (for ASQ 48 months); higher score indicates worse outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Performance, Ages 4 years and older
This outcome will be assessed by asking parents "My child does well with schoolwork, learning, and grades." There are 5 options from Strongly agree to Strongly disagree. Range is 1-5; higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Relationships, Ages 4 and older
This outcome will be measured by asking "My child has strong relationships at school" with 5 options from Strongly agree to Strongly disagree. Range is 1-5; higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Family Health
This outcome will be assessed by the Family Health Scale - Short Form, which measures the health and function of the family unit. Range is 0-10; higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Financial Wellbeing
This outcome will be assessed by the Consumer Financial Protection Bureau (CFPB) Financial Wellbeing Scale, which measures a person's financial well-being, such as the extent to which someone's financial situation and the financial capability that they have developed provide them with security and freedom of choice. CFPB Financial Well-Being Scale score range is 22-87; higher score indicates better outcome.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Hunger
This outcome will be assessed by the USDA Hunger Vital Sign, which identifies whether or not a household is at risk of food insecurity. If they answer that either or both of two statements is 'often true' or 'sometimes true' (vs. 'never true'), the household is identified as being at risk for food insecurity.
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Function and Material Resources: Basic Needs
This outcome will be assessed by the Protective Factors Survey version 2.0, which assesses family basic needs across multiple domains, including family functioning/resiliency, social support, concrete support, and nurturing/attachment. Mean domain score range is 0-4; higher score indicates better outcome
Measured: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start31 Aug 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health ServicesStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Chung
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, 211 Los Angeles, Northeast Valley Health Corporation
- Responsible party
- Sponsor-investigator, Paul Chung, Kaiser Permanente
- Investigators
- Paul J Chung, MD, MS, Principal investigator, Kaiser Permanente Bernard J. Tyson School of MedicineRebecca N Dudovitz, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686614
- Sponsor's protocol ID
- 2227014
- Other IDs
- 1R01HD116727-01A1
- Acronym
- CARE
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identifiable IPD data collected throughout the trial that is not protected by licensing will be shared. This includes: Longitudinal Interview Survey Data, Abstracted Medical Record Data from Well Child Clinical Encounters, Intervention Activity Record Data, and Qualitative Interview Data.
Publications
Lim Chang C, Chung PJ, Ngan H, Porras-Javier L, Vangala S, Correa-Mendoza L, Calderon K, Thompson LR, Molina D, Aceves I, Torres F, Dudovitz R. Testing a Scalable Model for Adverse Childhood Experiences-Related Care Coordination via 211 Telephone-Based Services. Acad Pediatr. 2026 Jan-Feb;26(1):103160. doi: 10.1016/j.acap.2025.103160. Epub 2025 Oct 27.
PubMed 41161485
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Based Care Coordination for Services Addressing Childhood Adversity
- ClinicalTrials.gov ID
- NCT07686614
- Acronym / sponsor ID
- CARE / 2227014
- Conditions
- Health Services, Mental Health, Well-being
- Keywords
- child health, adverse childhood experiences, care coordination, parent health, parent mental health, child mental health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- Paul ChungUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, Los Angeles, 211 Los Angeles, Northeast Valley Health Corporation
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 7 Jul 2026 (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 study is to learn how telephone-based screening and care coordination impacts children experiencing adverse childhood events (ACEs). The main questions are:
- Does telephone-based screening and care coordination for children experiencing ACEs increase child receipt of ACEs-related services?
- Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing?
- Does telephone-based screening and care coordination for children experiencing ACEs improve child social and emotional health?
Researchers will compare families who have been randomly selected to receive telephone-based screening and care coordination with those who will receive usual care at their clinic.
Participants will:
- Be randomly assigned to receive usual care or usual care plus telephone-based screening and care coordination (the intervention)
- If selected for the intervention, be connected to 211 Los Angeles to receive screening and care coordination for up to 6 months
- Complete four surveys via interview; surveys will be done at enrollment and 1 month, 6 months, and 12 months following enrollment
- Agree to allow researchers to review their child's medical records to collect information about their child's health, screenings, diagnoses, and referrals.
Detailed description
Throughout the recruitment period, clinic partners will send an opt-out letter or text message to all families with an upcoming well-child visit in the next month, providing instructions for how families can opt out of study recruitment efforts. Those who do not opt out may be contacted by phone by the study team. Potential participants will be selected for contact from a clinic's appointment list utilizing a random number generator roughly one month prior to their scheduled well-child visit to invite them to participate. Invitations will continue until weekly quotas for enrollment are met. Upon contacting the family, the study team Research Associate will screen for eligibility and explain the study.
If the child is eligible and the family is interested in participating, the RA will obtain electronic parent permission and consent for study participation and electronic HIPAA authorization for research for the study team to obtain information from the medical chart.
Following the consent process, the research team will administer the baseline survey over the phone. The survey will include socio-demographic characteristics as well as measures for family functioning and material resources and parent and child health and wellbeing.
Following baseline survey completion, children will be individually randomized to the intervention or control group. Randomization will be stratified by clinic system to ensure even representation across intervention and control groups in each clinic system. To determine group assignment, the RA will enter the clinic in REDCap, which will reveal the assigned group (intervention or control) using a permuted block randomization list generated by the statistician. The RA will provide the participant with their group assignment at this time as well as briefly describe the intervention further for the intervention group.
After randomization is complete, those in the intervention group will be connected to 211 LA via warm transfer phone call or by providing the family's contact information to 211 LA. Once connected to the parent, the 211 LA Care Coordination specialist will conduct ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, 211 LA will provide information about and connection to relevant evaluations and services, with specific attention to mental health, child development, and material needs and services. The care coordinator specialist will stay in touch with the family (contacting families 1 or 2 times per month based on coordinator-assessed need) for up to 6 months, until the parent wishes to discontinue contact, or the child is enrolled in all desired services. Families are encouraged to call 211 LA with additional questions or concerns.
Both intervention and control group families will receive usual well-child care and ACEs screening using the PEARLS in the clinic. Providers will provide referrals and care coordination per their current practices and will be blinded as to study group assignment during the intervention.
In addition to the baseline survey, participants will be contacted by the research team via phone roughly 1 month following enrollment to learn about any initial referrals the family received through either the clinic or 211 LA. In addition, parents will be asked to complete a follow-up survey over the phone at 6 and 12 months following enrollment, for a total of four surveys. After completion of each survey, parents will receive a monetary incentive to compensate them for their time.
The study team will also obtain intervention group data from 211 LA regarding ACEs screening results, referrals, and referral outcomes. Finally, the study team will review charts 6 months after enrollment for both intervention and control groups regarding clinic-based ACEs screening results, referrals, and services.
Study data will be collected and managed using REDCap (Research Electronic Data Capture), a secure web application designed to support data capture for research studies, providing web-based case report forms, real-time data entry validation, audit trails, and a de-identified data export to common statistical packages.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Receipt of usual well child care and ACEs screening using the PEARLS in the clinic. Participants may receive referrals and care coordination per their clinic's current practices. |
| Intervention + Usual Care | Experimental | Behavioral: Telephone-based Screening and Care CoordinationA Care Coordination specialist will conduct ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, the specialist will recommend and provide information about and connection to relevant evaluations and services. Participants will continue to receive usual well child care and ACEs screening using the PEARLS in the clinic. Participants may receive referrals and care coordination per their clinic's current practices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or legal guardian of focal child
- Comfortable completing surveys in English or Spanish
- Focal child is less than 12 years of age at enrollment
Key exclusion criteria (3 listed)
- Focal child participated in the 'UCANN" pilot study
- Focal child's sibling is enrolled in this study
- Focal child is currently assigned a DCFS (Department of Child and Family Services) case worker
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 |
|---|---|---|
| Telephone-based Screening and Care CoordinationOnce connected to the parent, the 211 LA Care Coordination specialist will administer ACEs screening over the phone using the PEARLS Part 1 and Part 2 questionnaire. Based on the ACEs screening results, 211 LA will provide information about and connection to relevant evaluations and services, with specific attention to mental health, child development, and material needs and services. The care coordinator specialist will stay in touch with the family (contacting families 1 or 2 times per month based on coordinator-assessed need) for up to 6 months, until the parent wishes to discontinue contact or the child is enrolled in all desired services. | Behavioural | Intervention + Usual Care |
Primary outcome
Receipt of ACEs-related services
Time frame: Between baseline and follow-up surveys 6-9 months after baseline
Assessed by whether a child receives an ACEs-related service by 6 months (i.e., at least 1 specific service appointment made and kept, per parent report). We will primarily consider referrals to mental health (child, adult, and family), child development (preschool, early intervention, and specific developmental services), and material resources (e.g., food, housing, income, transportation), although we may include other categories as appropriate, such as services that support psychosocial wellbeing (e.g., school tutoring, sports, exposure to nature) or access to healthcare.
Parent health and Wellbeing: Global Physical Health
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales. Global Physical Health subscale score (calculated from 4 items), T-score range 16.2-67.7, higher score indicates better outcome.
Parent Health and Wellbeing - Global Mental Health
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
Assessed by Patient-Reported Outcomes Measurement Information System 10 (PROMIS 10) Global Health Scale v1.2.52, which is a general health measure with mental and physical health subscales. Global Mental Health subscale score (calculated from 4 items), T score range 21.2-67.6, higher score indicates better outcome.
Child social-emotional wellbeing, under the age of 3
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
This outcome will be assessed by Ages and Stages Questionnaire: Social-Emotional, 2nd Edition (ASQ:SE) for children under age 3, which assesses children's social-emotional health across domains of self-regulation, compliance, social-communication, adaptive functioning, autonomy, affect, and interaction with people. Range is 0-525 (for the 36 month questionnaire); higher score indicates worse outcome. We will compare the 12-month outcome scores (ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
Child Social-Emotional Wellbeing, ages 3 and older
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline. Outcome analyzed at 12-15 months after baseline
This outcome will be assessed by the Strengths and Difficulties Questionnaire (SDQ) for children 3 years and older, which assesses children's wellbeing across domains of emotional, conduct, hyperactivity/inattention, and peer problems, as well as prosocial behavior. Total Difficulties Score Range is 0-40 with higher score indicating worse outcome. We will compare the 12-month outcome scores (SDQ Total Difficulties Score and ASQ:SE Total Score) in the intervention group against the 12-month outcome scores in the control group, controlling for the baseline outcome score, and we may conduct other analyses for this outcome as appropriate.
14 secondary outcomes
Receipt of ACEs-related referrals
Time frame: Between baseline and follow-up surveys 6-9 months after baseline
Number of ACEs-related referrals per family
Time frame: By the time of the 6-9 month and 12-15 month follow-up surveys
Number of ACEs-related services received per family
Time frame: By the time of the 6-9 month and 12-15 month follow-up surveys
Parent Emotional Wellbeing: Psychological Distress
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Parent Emotional Wellbeing: Perceived Stress
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Parent Emotional Wellbeing: Parental Stress
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: Attendance
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Readiness, Ages 2-3 years 11 months
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Performance, Ages 4 years and older
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Child School Functioning: School Relationships, Ages 4 and older
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Family Health
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Financial Wellbeing
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Functioning and Material Resources: Hunger
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
Family Function and Material Resources: Basic Needs
Time frame: Longitudinal data collected at baseline, 6-9 months after baseline, and 12-15 months after baseline.
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 2 Oct 2026.
- Background: PubMed 41161485Lim Chang C, Chung PJ, Ngan H, Porras-Javier L, Vangala S, Correa-Mendoza L, Calderon K, Thompson LR, Molina D, Aceves I, Torres F, Dudovitz R. Testing a Scalable Model for Adverse Childhood Experiences-Related Care Coordination via 211 Telephone-Based Services. Acad Pediatr. 2026 Jan-Feb;26(1):103160. doi: 10.1016/j.acap.2025.103160. Epub 2025 Oct 27.
- Individual participant dataSharing planned: Yes. All de-identifiable IPD data collected throughout the trial that is not protected by licensing will be shared. This includes: Longitudinal Interview Survey Data, Abstracted Medical Record Data from Well Child Clinical Encounters, Intervention Activity Record Data, and Qualitative Interview Data.
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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.
Paul J Chung, MD, MS principal investigator
Kaiser Permanente Bernard J. Tyson School of Medicine
Rebecca N Dudovitz, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based Screening and Care Coordination in people with Health Services and Mental Health, run by Paul Chung 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. 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.
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?
Receipt of ACEs-related services (time frame: Between baseline and follow-up surveys 6-9 months after baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07686614, which also lists 1 linked publication.
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 2 Oct 2026.