Telephone-Based Care Coordination for Services Addressing Childhood Adversity

NCT07686614 | Not Yet Recruiting DMC

• 2 other identifiers: 22270141R01HD116727-01A1
• Study Type: interventional
• Target: 778
• Locations: 0 countries
• Sites: N/A

Brief 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:

• 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.

Conditions

Mental Health; Well-being; Health Services

Keywords

child health; adverse childhood experiences; care coordination; parent health; parent mental health; child mental health

Outcome Measures

Primary Outcomes (5)

• 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.

  Between enrollment and follow-up surveys 6-9 months after enrollment

• 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.

  Between enrollment and follow-up surveys 12-15 months after enrollment

• 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.

  Time Frame: Between enrollment and follow-up surveys 12-15 months after enrollment

• 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.

  Between enrollment and follow-up surveys 12-15 months after enrollment

• 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.

  Between enrollment and follow-up surveys 12-15 months after enrollment

Secondary Outcomes (14)

• Receipt of ACEs-related referrals

  Between enrollment and follow-up surveys 6-9 months after enrollment

• Number of ACEs-related referrals per family

  By the time of the 6-9 month and 12-15 month follow-up surveys

• Number of ACEs-related services received per family

  By the time of the 6-9 month and 12-15 month follow-up surveys

• Parent Emotional Wellbeing: Psychological Distress

  Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.

• Parent Emotional Wellbeing: Perceived Stress

  Longitudinal data collected at baseline, 6-9 months after enrollment, and 12-15 months after enrollment.

Study Arms (2)

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.

Behavioral: Telephone-based Screening and Care Coordination

Interventions

Telephone-based Screening and Care Coordination BEHAVIORAL

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.

Intervention + Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul Chung: lead
• University of California, Los Angeles: collaborator
• 211 Los Angeles: collaborator
• Northeast Valley Health Corporation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (1)

• 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.

  PMID: 41161485 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Paul J Chung, MD, MS

  Kaiser Permanente Bernard J. Tyson School of Medicine

  PRINCIPAL INVESTIGATOR

• Rebecca N Dudovitz, MD, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances C Kwan, DPT

CONTACT

626-833-6284; frances.c.kwan@kp.org

Lorena Porras-Javier, MPH

CONTACT

310-486-6543; lporras@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair, Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: IPD sharing will be managed by the NIH NICHD Data and Specimen Hub (DASH).