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

29 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

778

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: 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.
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Receipt of ACEs-related services
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Receipt of ACEs-related referrals
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Paul Chung

Współpracownicy

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

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

31 marca 2030

Ukończenie studiów (Szacowany)

31 marca 2030

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

7 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2227014
  • 1R01HD116727-01A1 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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