Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
- Conditions
- Health Services ResearchChild Development
- Interventions
- Behavioral: Telephone-based early childhood developmental care coordination
- Registration Number
- NCT04118452
- Lead Sponsor
- University of California, Los Angeles
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 565
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention + Usual Care + Developmental Screening Results Telephone-based early childhood developmental care coordination Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention.
- Primary Outcome Measures
Name Time Method Referral to, eligibility for, and receipt of early childhood developmental services 6 months after enrollment 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.
Child Developmental Outcomes Change in child developmental assessment score between baseline and 24 months after enrollment 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.
Intervention Cost / Benefit Analysis 24 months after enrollment 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.
- Secondary Outcome Measures
Name Time Method Number of referrals, number of children eligible for services, and number of children who have received services 6 months after enrollment 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.
Trial Locations
- Locations (4)
South Central Family Health Center
🇺🇸Los Angeles, California, United States
Via Care
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
ChapCare
🇺🇸Pasadena, California, United States