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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05567250
Other study ID # 22-000405
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2022
Est. completion date November 24, 2023

Study information

Verified date February 2024
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date November 24, 2023
Est. primary completion date August 7, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 11 Years
Eligibility 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: - Child or sibling already enrolled in this study - Child or sibling enrolled in the AMP Child Development study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral: 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.

Locations

Country Name City State
United States University of California Los Angeles Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Kaiser Permanente School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Receipt of ACEs-related services The percentage of children who receive at least one ACEs-related service, as reported on the participant survey. 2-6 months after enrollment
Secondary Number of referrals received The number of referrals made for ACEs-related services, as reported on the participant survey. 2-6 months after enrollment
Secondary Number of services received The number of ACEs-related services received, as reported on the participant survey. 2-6 months after enrollment
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