Child Development, Health Services Research
Conditions
Keywords
early childhood development, developmental screening, care coordination
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.
Interventions
BEHAVIORALTelephone-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 (Electronic Medical Record) 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.
Sponsors
Kaiser Permanente School of Medicine
Virginia Commonwealth University
Information and Referral Federation of Los Angeles County (211 LA County)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Months to 42 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, and 2) the percentage of children who receive services. |
| Child Developmental Outcomes | Baseline and 24 months after enrollment | The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's developmental age as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | 6 months after enrollment | The secondary outcome will be assessed by the number of 1) children with referrals made, and 2) children with services received; 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. Intervention services include Part C early intervention (EI), Part B early childhood special education (ECSE), physical therapy (PT), occupational therapy (OT), and speech therapy. Early care and education (ECE) includes child care, preschool, Head Start, and Early Head Start. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention + Usual Care + Developmental Screening Results 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.
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. | 278 |
| Usual Care + Developmental Screening Results This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. | 281 |
| Total | 559 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Withdrawal by Subject | 17 | 17 |
Baseline characteristics
| Characteristic | Usual Care + Developmental Screening Results | Total | Intervention + Usual Care + Developmental Screening Results |
|---|---|---|---|
| Age, Continuous | 20.6 Months STANDARD_DEVIATION 8.7 | 20.0 Months STANDARD_DEVIATION 8.4 | 19.4 Months STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 235 Participants | 476 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 82 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 41 Participants | 71 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 163 Participants | 331 Participants | 168 Participants |
| Race (NIH/OMB) White | 60 Participants | 123 Participants | 63 Participants |
| Region of Enrollment United States | 281 participants | 559 participants | 278 participants |
| Sex: Female, Male Female | 123 Participants | 247 Participants | 124 Participants |
| Sex: Female, Male Male | 158 Participants | 312 Participants | 154 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 278 | 0 / 281 |
| other Total, other adverse events | 0 / 278 | 0 / 281 |
| serious Total, serious adverse events | 0 / 278 | 0 / 281 |
Outcome results
Primary
Child Developmental Outcomes
The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's developmental age as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve.
Time frame: Baseline and 24 months after enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention + Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Expressive Language Standardized Score - Baseline | 125.3 Standardized Score | Standard Deviation 41.3 |
| Intervention + Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Expressive Language Standardized Score - 24 Months | 119.2 Standardized Score | Standard Deviation 35.6 |
| Intervention + Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL - Receptive Language Standardized Score - Baseline | 123.6 Standardized Score | Standard Deviation 55.9 |
| Intervention + Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Receptive Language Standardized Score - 24 Months | 139.2 Standardized Score | Standard Deviation 48.8 |
| Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Receptive Language Standardized Score - 24 Months | 137.3 Standardized Score | Standard Deviation 50.1 |
| Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Expressive Language Standardized Score - Baseline | 125.4 Standardized Score | Standard Deviation 40.6 |
| Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL - Receptive Language Standardized Score - Baseline | 124.0 Standardized Score | Standard Deviation 50.4 |
| Usual Care + Developmental Screening Results | Child Developmental Outcomes | PEDS DM-AL Expressive Language Standardized Score - 24 Months | 117.6 Standardized Score | Standard Deviation 41.2 |
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, and 2) the percentage of children who receive services.
Time frame: 6 months after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention + Usual Care + Developmental Screening Results | Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | Received a referral to early childhood developmental services | 24.5 percentage of children |
| Intervention + Usual Care + Developmental Screening Results | Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | Received early childhood developmental services | 14.5 percentage of children |
| Usual Care + Developmental Screening Results | Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | Received a referral to early childhood developmental services | 16.3 percentage of children |
| Usual Care + Developmental Screening Results | Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | Received early childhood developmental services | 8.8 percentage of children |
Secondary
Number of Children Who Have Received Referrals and Number of Children Who Have Received Services
The secondary outcome will be assessed by the number of 1) children with referrals made, and 2) children with services received; 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. Intervention services include Part C early intervention (EI), Part B early childhood special education (ECSE), physical therapy (PT), occupational therapy (OT), and speech therapy. Early care and education (ECE) includes child care, preschool, Head Start, and Early Head Start.
Time frame: 6 months after enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention + Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received intervention services | 36 participants |
| Intervention + Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for intervention services | 61 participants |
| Intervention + Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for early care and education (ECE) services | 144 participants |
| Intervention + Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received early care and education (ECE) services | 65 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received intervention services | 30 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for early care and education (ECE) services | 49 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for intervention services | 47 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received early care and education (ECE) services | 30 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for intervention services | 43 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received intervention services | 23 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received early care and education (ECE) services | 27 participants |
| Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for early care and education (ECE) services | 40 participants |
| High or Moderate Risk - Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received early care and education (ECE) services | 9 participants |
| High or Moderate Risk - Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for early care and education (ECE) services | 16 participants |
| High or Moderate Risk - Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received intervention services | 16 participants |
| High or Moderate Risk - Usual Care + Developmental Screening Results | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | Received a referral for intervention services | 32 participants |