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Telephone-Based Care Coordination for Services Addressing Childhood Adversity (CARE)

29 juni 2026 bijgewerkt door: Paul Chung

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. Does telephone-based screening and care coordination for children experiencing ACEs improve parent health and wellbeing?
  3. 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

778

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Usual Care
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.
Experimenteel: Intervention + Usual Care

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.
Gedragsmatig: Telephone-based Screening and Care Coordination
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Receipt of ACEs-related services
Tijdsspanne: Between enrollment and follow-up surveys 6-9 months after enrollment

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.
Between enrollment and follow-up surveys 6-9 months after enrollment
Parent health and Wellbeing: Global Physical Health
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment

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.
Between enrollment and follow-up surveys 12-15 months after enrollment
Parent Health and Wellbeing - Global Mental Health
Tijdsspanne: Time Frame: Between enrollment and follow-up surveys 12-15 months after enrollment
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.
Time Frame: Between enrollment and follow-up surveys 12-15 months after enrollment
Child social-emotional wellbeing, under the age of 3
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
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.
Between enrollment and follow-up surveys 12-15 months after enrollment
Child Social-Emotional Wellbeing, ages 3 and older
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
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.
Between enrollment and follow-up surveys 12-15 months after enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Receipt of ACEs-related referrals
Tijdsspanne: Between enrollment and follow-up surveys 6-9 months after enrollment

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.
Between enrollment and follow-up surveys 6-9 months after enrollment
Number of ACEs-related referrals per family
Tijdsspanne: By the time of the 6-9 month and 12-15 month follow-up surveys
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.
By the time of the 6-9 month and 12-15 month follow-up surveys
Number of ACEs-related services received per family
Tijdsspanne: By the time of the 6-9 month and 12-15 month follow-up surveys
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.
By the time of the 6-9 month and 12-15 month follow-up surveys
Parent Emotional Wellbeing: Psychological Distress
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Parent Emotional Wellbeing: Perceived Stress
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Parent Emotional Wellbeing: Parental Stress
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Child School Functioning: Attendance
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
Number of missed days in the last 12 months that school/preschool/daycare was in session
Between enrollment and follow-up surveys 12-15 months after enrollment
Child School Functioning: School Readiness, Ages 2-4 years
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
This outcome will be assessed in participants under ages 2-4 years 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.
Between enrollment and follow-up surveys 12-15 months after enrollment
Child School Functioning: School Performance, Ages 4 and older
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
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.
Between enrollment and follow-up surveys 12-15 months after enrollment
Child School Functioning: School Relationships, Ages 4 and older
Tijdsspanne: Between enrollment and follow-up surveys 12-15 months after enrollment
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.
Between enrollment and follow-up surveys 12-15 months after enrollment
Family Functioning and Material Resources: Family Health
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Family Functioning and Material Resources: Financial Wellbeing
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Family Functioning and Material Resources: Hunger
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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.
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
Family Function and Material Resources: Basic Needs
Tijdsspanne: Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.
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
Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Paul Chung

Medewerkers

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
211 Los Angeles
Northeast Valley Health Corporation

Onderzoekers

  • Hoofdonderzoeker: Paul J Chung, MD, MS, Kaiser Permanente Bernard J. Tyson School of Medicine
  • Hoofdonderzoeker: Rebecca N Dudovitz, MD, MS, University of California, Los Angeles

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 maart 2030

Studie voltooiing (Geschat)

31 maart 2030

Studieregistratiedata

Eerst ingediend

18 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2227014
  • 1R01HD116727-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

The full set of Scientific Data anticipated to be shared under this project will be made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period (July 2030), whichever comes first.

IPD-toegangscriteria voor delen

IPD sharing will be managed by the NIH NICHD Data and Specimen Hub (DASH).

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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