Trial Outcomes & Findings for Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening (NCT NCT02495025)
NCT ID: NCT02495025
Last Updated: 2019-10-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
6 months
Results posted on
2019-10-14
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
75
|
|
Overall Study
COMPLETED
|
51
|
61
|
|
Overall Study
NOT COMPLETED
|
26
|
14
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
14
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening
Baseline characteristics by cohort
| Measure |
Telephone-based Screening
n=77 Participants
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
|
Usual Care
n=75 Participants
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.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.7 months
STANDARD_DEVIATION 9.5 • n=5 Participants
|
23.3 months
STANDARD_DEVIATION 7.9 • n=7 Participants
|
24.5 months
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Latino or Hispanic
|
72 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White, non-Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black of African-American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsWe 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.
Outcome measures
| Measure |
Telephone-based Screening
n=77 Participants
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
|
Usual Care
n=75 Participants
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.
|
|---|---|---|
|
Number of Participants Screened With a Validated Tool
|
57 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBased on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.
Outcome measures
| Measure |
Telephone-based Screening
n=77 Participants
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
|
Usual Care
n=75 Participants
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.
|
|---|---|---|
|
Number of Participants That Receive Services
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsBased 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.
Outcome measures
| Measure |
Telephone-based Screening
n=77 Participants
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
|
Usual Care
n=75 Participants
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.
|
|---|---|---|
|
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
|
25 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Restricted to participants with parent interview at both baseline and 6-month follow-up.
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)
Outcome measures
| Measure |
Telephone-based Screening
n=51 Participants
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
|
Usual Care
n=61 Participants
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.
|
|---|---|---|
|
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
|
55.1 percentage of items
Standard Deviation 29.1
|
|
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
|
89.2 percentage of items
Standard Deviation 20.5
|
|
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
|
54.6 percentage of items
Standard Deviation 32.8
|
|
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
|
83.1 percentage of items
Standard Deviation 31.1
|
Adverse Events
Telephone-based Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Research Manager, Health Services Research Program
University of California Los Angeles
Phone: 310-825-8624
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place