Adverse Childhood ExperiencesNCT05567250
Testing a Scalable Model For ACEs-Related Care Navigation
A study testing Behavioral: Telephone-based ACEs care coordination in people with Adverse Childhood Experiences and Child Development, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences, Child Development
- What is being tested?
- Behavioral: Telephone-based ACEs care coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 24 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Child or sibling already enrolled in this study
- Child or sibling enrolled in the AMP Child Development study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Testing a Scalable Model For ACEs-Related Care Navigation Via 211 Telephone-Based Services
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.
- Conditions
- Adverse Childhood Experiences, Child Development
- Being tested
- Behavioral: Telephone-based ACEs care coordination
- Keywords
- Health Services Research, Care Coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Telephone-based ACEs care coordinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention + Usual Care | Experimental | Intervention group families will receive usual care and they will be connected via telephone to 211LA. Receives: Behavioral: Behavioral: Telephone-based ACEs care coordination |
| No Intervention: Usual Care | No intervention | This group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-6 months after enrollment
Secondary outcomes (3)
Receipt of ACEs-related services
The percentage of children who receive at least one ACEs-related service, as reported on the participant survey.
Measured: 2-6 months after enrollment
Number of referrals received
The number of referrals made for ACEs-related services, as reported on the participant survey.
Measured: 2-6 months after enrollment
Number of services received
The number of ACEs-related services received, as reported on the participant survey.
Measured: 2-6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start5 Oct 2022
- Primary completion7 Aug 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente School of Medicine
- Responsible party
- Principal investigator, Rebecca Dudovitz, MD, MSHS, University of California, Los Angeles
- Investigators
- Rebecca Dudovitz, MD MSHS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567250
- Sponsor's protocol ID
- 22-000405
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be shared.
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 30894408Lim 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.
PubMed 41161485
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Scalable Model For ACEs-Related Care Navigation Via 211 Telephone-Based Services
- ClinicalTrials.gov ID
- NCT05567250
- Acronym / sponsor ID
- 22-000405
- Conditions
- Adverse Childhood Experiences, Child Development
- Keywords
- Health Services Research, Care Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Kaiser Permanente School of Medicine
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention + Usual Care | Experimental | Behavioral: Behavioral: Telephone-based ACEs care coordinationIntervention group families will receive usual care and they will be connected via telephone to 211LA. |
| No Intervention: Usual Care | No intervention | –This group will receive usual care |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Child or sibling already enrolled in this study
- Child or sibling enrolled in the AMP Child Development study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Telephone-based ACEs care coordinationThe 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. | Behavioural | Experimental Intervention + Usual Care |
Primary outcome
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.
3 secondary outcomes
Receipt of ACEs-related services
Time frame: 2-6 months after enrollment
Number of referrals received
Time frame: 2-6 months after enrollment
Number of services received
Time frame: 2-6 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 30894408Nelson 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.
- Derived from this study: PubMed 41161485Lim 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Dudovitz, MD MSHS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Telephone-based ACEs care coordination in people with Adverse Childhood Experiences and Child Development, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referrals to ACEs-related services (time frame: 2-6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567250, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.