Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

Child Development Clinical Trial

— AMP  

Official title:

A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118452
• Other study ID #: 19-001556
• Secondary ID: 7R01HD092406-02
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: May 23, 2023

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 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 for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.

Description:

The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).

Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.

Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Months to 42 Months

Eligibility

Inclusion Criteria:

• A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care)

• A patient with an upcoming one- to three-year old well child appointment scheduled

• Child aged 11-42 months

Exclusion Criteria:

• Parent who does not speak English or Spanish

• Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services.

• Child has a sibling already enrolled in the study.

Related Conditions & MeSH terms

• Child Development
• Health Services Research

Intervention

Behavioral:
• Telephone-based early childhood developmental care coordination
The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly 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	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	South Central Family Health Center	Los Angeles	California
United States	Via Care	Los Angeles	California
United States	ChapCare	Pasadena	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Information and Referral Federation of Los Angeles County (211 LA County), Kaiser Permanente School of Medicine, Virginia Commonwealth University

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	Referral to, eligibility for, and receipt of early childhood developmental services 6 months after enrollment	The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, 2) the percentage of children who are deemed eligible for services by service organizations, and 3) the percentage of children who receive services.	6 months after enrollment
Primary	Child Developmental Outcomes	The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) will be used to determine developmental assessment scores. All children will receive the language sub-scale of this instrument, and those children who screened positive (at high or moderate risk on the PEDS Online) will receive the full assessment.	Change in child developmental assessment score between baseline and 24 months after enrollment
Primary	Intervention Cost / Benefit Analysis	Intervention costs per child screened are composed of the 211LA program costs for care coordination and the costs of services received. Intervention benefits are the long-term benefits of service receipt in terms of potential changes in employment, income, crime, and life expectancy.	24 months after enrollment
Secondary	Number of referrals, number of children eligible for services, and number of children who have received services	The secondary outcome will be assessed by the average number of 1) referrals made, 2) services for which children are deemed eligible, and 3) services received for each family; the investigators will primarily consider referrals to high-level intervention services for developmental and behavioral problems, but will also track referrals to development-related preventive and support services.	6 months after enrollment