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OpenTrials
Completed

NCT Number: NCT05567250

Testing a Scalable Model For ACEs-Related Care Navigation

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.

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Key information

Conditions

Adverse Childhood Experiences Child Development

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral: Telephone-based ACEs care coordination

Behavioral

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.

Primary outcomes

  1. Referrals to ACEs-related services

    Time frame: 2-6 months after enrollment

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

Secondary outcomes

  1. Receipt of ACEs-related services

    Time frame: 2-6 months after enrollment

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

  2. Number of referrals received

    Time frame: 2-6 months after enrollment

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

  3. Number of services received

    Time frame: 2-6 months after enrollment

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Kaiser Permanente School of Medicine

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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