Testing a Scalable Model For ACEs-Related Care Navigation

Child Development Clinical Trial

Official title:

Testing a Scalable Model For ACEs-Related Care Navigation Via 211 Telephone-Based Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567250
• Other study ID #: 22-000405
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Child Development

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