Child Development Clinical Trial
— AMPOfficial title:
A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
Verified date | March 2024 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
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 |
United States,
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
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 |
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