NCT05567250

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

September 28, 2022

Last Update Submit

February 12, 2024

Conditions

Keywords

Health Services ResearchCare Coordination

Outcome Measures

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.

    2-6 months after enrollment

Secondary Outcomes (3)

  • Receipt of ACEs-related services

    2-6 months after enrollment

  • Number of referrals received

    2-6 months after enrollment

  • Number of services received

    2-6 months after enrollment

Study Arms (2)

Experimental Intervention + Usual Care

EXPERIMENTAL

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: Usual Care

NO INTERVENTION

This group will receive usual care

Interventions

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.

Experimental Intervention + Usual Care

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

  • 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.

    PMID: 30894408BACKGROUND
  • 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.

Study Officials

  • Rebecca Dudovitz, MD MSHS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 5, 2022

Study Start

October 5, 2022

Primary Completion

August 7, 2023

Study Completion

November 24, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared within 2 years of study completion.
Access Criteria
Proposals should be directed to lporras@mednet.ucla.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be provided when requests are approved.

Locations