Ambulatory Care, Child Development, Developmental Disabilities, Screening
Conditions
Brief summary
The purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic. Investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.
Detailed description
Although the American Academy of Pediatrics (AAP) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the AAP guidelines. One intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns. 2-1-1 Los Angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design. Investigators partnered with the Clinica Oscar A Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income Latino families. Investigators hope to enroll up to 300 families in the study. Eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic. As investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups. Intervention group families will be transferred to 211 Los Angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.
Interventions
BEHAVIORALTelephone-based developmental screening and care coordination
Sponsors
Robert Wood Johnson Foundation
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants were randomized individually at the time of enrollment, to receive either telephone-based developmental screening and care coordination, through 2-1-1 Los Angeles, in addition to usual care, or usual care alone. Primary outcomes were measured at 6 months after enrollment.
Eligibility
Sex/Gender
ALL
Age
12 Months to 42 Months
Healthy volunteers
Yes
Inclusion criteria
* child receives well-child care at the clinic * child is not already receiving intervention services for a developmental disability * parent speaks Spanish or English well enough to be interviewed
Exclusion criteria
* child is younger than 12 months or older than 42 months at time of enrollment * child is already receiving intervention services for a developmental disability * parent is unable to speak Spanish or English well enough to be interviewed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Screened With a Validated Tool | 6 months | We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP. Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version. |
| Number of Participants That Receive Services | 6 months | Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education) | 6 months | Based on medical record review, parent report, and 211 data, we measured whether any referrals were made for children with developmental or behavioral concerns, for evaluation or services. |
| Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | Baseline and 6 months | Based on parent interviews we will assess family experiences with primary care including receipt of recommended well-child care, using recommended anticipatory guidance and family-centered care items from the Promoting Healthy Development Survey (PHDS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telephone-based Screening Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone. Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT). If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services. A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.
Telephone-based developmental screening and care coordination | 77 |
| Usual Care Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination. Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation. | 75 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 14 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | Telephone-based Screening |
|---|---|---|---|
| Age, Continuous | 23.3 months STANDARD_DEVIATION 7.9 | 24.5 months STANDARD_DEVIATION 8.8 | 25.7 months STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized Race/ethnicity Black of African-American | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/ethnicity Latino or Hispanic | 71 Participants | 143 Participants | 72 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/ethnicity Unknown | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity White, non-Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 43 Participants | 76 Participants | 33 Participants |
| Sex: Female, Male Male | 32 Participants | 76 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 75 |
| other Total, other adverse events | 0 / 77 | 0 / 75 |
| serious Total, serious adverse events | 0 / 77 | 0 / 75 |
Outcome results
Primary
Number of Participants Screened With a Validated Tool
We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP. Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone-based Screening | Number of Participants Screened With a Validated Tool | 57 Participants |
| Usual Care | Number of Participants Screened With a Validated Tool | 0 Participants |
Primary
Number of Participants That Receive Services
Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone-based Screening | Number of Participants That Receive Services | 12 Participants |
| Usual Care | Number of Participants That Receive Services | 1 Participants |
Secondary
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
Based on medical record review, parent report, and 211 data, we measured whether any referrals were made for children with developmental or behavioral concerns, for evaluation or services.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone-based Screening | Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education) | 25 Participants |
| Usual Care | Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education) | 7 Participants |
Secondary
Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
Based on parent interviews we will assess family experiences with primary care including receipt of recommended well-child care, using recommended anticipatory guidance and family-centered care items from the Promoting Healthy Development Survey (PHDS)
Time frame: Baseline and 6 months
Population: Restricted to participants with parent interview at both baseline and 6-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telephone-based Screening | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | Baseline% recommended anticipatory guidance topics | 61.0 percentage of items | Standard Deviation 29.7 |
| Telephone-based Screening | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | Baseline% family-centered care (usually/always) | 87.2 percentage of items | Standard Deviation 24.5 |
| Telephone-based Screening | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | 6-months% recommended anticipatory guidance topics | 68.1 percentage of items | Standard Deviation 26.4 |
| Telephone-based Screening | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | 6-months% family-centered care (usually/always) | 84.9 percentage of items | Standard Deviation 28.3 |
| Usual Care | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | 6-months% family-centered care (usually/always) | 83.1 percentage of items | Standard Deviation 31.1 |
| Usual Care | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | Baseline% recommended anticipatory guidance topics | 55.1 percentage of items | Standard Deviation 29.1 |
| Usual Care | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | 6-months% recommended anticipatory guidance topics | 54.6 percentage of items | Standard Deviation 32.8 |
| Usual Care | Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always | Baseline% family-centered care (usually/always) | 89.2 percentage of items | Standard Deviation 20.5 |