CClinicalTrials.gg
CompletedNCT05567250Updated Feb 14, 2024

Testing a Scalable Model For ACEs-Related Care Navigation

An interventional study of Behavioral: Telephone-based ACEs care coordination in Adverse Childhood Experiences and Child Development, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged Up to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
Up to 11 Years
Sex
All
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Study summary

The study is a randomized controlled trial of a telephone-based care coordination system for families who experienced Adverse Childhood Events (ACEs). The investigators will conduct the study in partnership with Kaiser Permanente School of Medicine (KPSOM) and 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals and services for families who screen positive for ACEs.

Read the detailed description

The trial will enroll 200 children ages 0-11 years from the three FQHCs partner clinics, who screen positive for at least 1 ACE during their clinical encounter. The research study team will randomize children 1:1 into intervention (connection to 211LA for ACEs care coordination + usual care) or control (usual care alone).

Primary outcomes will include number of referrals to, eligibility for, and receipt of ACE-related services among intervention group participants compared to controls.

The investigators will measure these outcomes through parent reported data and 211LA data at baseline and 6 months after enrollment.

Expected findings include higher referral and service rates by six months after enrollment among intervention group participants.

02

Conditions studied

  • Adverse Childhood Experiences
  • Child Development

Keywords

  • Health Services Research
  • Care Coordination
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A patient in one of the three partner community clinic systems (ChapCare, Via Care and NEVHC)
  • Child aged 0 - 11 years old
  • Parent or legal guardian of child at least 18 years of age
  • Comfortable completing a survey by interview in English or Spanish

Exclusion criteria

Exclusion Criteria:

  • Child or sibling already enrolled in this study
  • Child or sibling enrolled in the AMP Child Development study
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Experimental Intervention + Usual Care

    Intervention group families will receive usual care and they will be connected via telephone to 211LA.

    Behavioral: Behavioral: Telephone-based ACEs care coordination

  • No intervention
    No Intervention: Usual Care

    This group will receive usual care

Interventions

  • BehavioralBehavioral: Telephone-based ACEs care coordination

    The 211LA care coordinator will use the agency's extensive resource directory to identify and provide appropriate referral recommendations to each family. In addition, they will develop a care coordination plan, noting these recommendations and plans for follow-up, to be provided to the family's clinical care provider. The coordinator will routinely follow-up with the family until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.

06

What researchers measure

Primary outcomes

  1. Referrals to ACEs-related services

    The percentage of children who are referred to at least one ACEs-related service, as reported on the participant survey.

    Time frame: 2-6 months after enrollment

Secondary outcomes

  1. Receipt of ACEs-related services

    The percentage of children who receive at least one ACEs-related service, as reported on the participant survey.

    Time frame: 2-6 months after enrollment

  2. Number of referrals received

    The number of referrals made for ACEs-related services, as reported on the participant survey.

    Time frame: 2-6 months after enrollment

  3. Number of services received

    The number of ACEs-related services received, as reported on the participant survey.

    Time frame: 2-6 months after enrollment

07

Study locations

1 site
  • University of California Los Angeles
    Los Angeles, California 90095, United States
08

References and documents

Publications

  • Nelson BB, Thompson LR, Herrera P, Biely C, Arriola Zarate D, Aceves I, Estrada I, Chan V, Orantes C, Chung PJ. Telephone-Based Developmental Screening and Care Coordination Through 2-1-1: A Randomized Trial. Pediatrics. 2019 Apr;143(4):e20181064. doi: 10.1542/peds.2018-1064. PubMed 30894408 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be shared.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05567250
Lead sponsor
University of California, Los Angeles
Collaborators
Kaiser Permanente School of Medicine
Responsible party
Rebecca Dudovitz, MD, MSHS (Associate Professor, University of California, Los Angeles) — Principal investigator
First posted
Oct 5, 2022
Start date
Oct 5, 2022
Primary completion
Aug 7, 2023
Completion
Nov 24, 2023
Last update
Feb 14, 2024

Study contacts

Rebecca Dudovitz, MD MSHS
principal investigator · University of California, Los Angeles

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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