Trial Outcomes & Findings for Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System (NCT NCT04118452)

Last Updated: 2025-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

565 participants

Primary outcome timeframe

6 months after enrollment

Results posted on

2025-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	282	283
Overall Study 6 Month Survey	249	263
Overall Study 12 Month Survey	251	256
Overall Study 24 Month Survey	250	249
Overall Study COMPLETED	260	261
Overall Study NOT COMPLETED	22	22

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	5
Overall Study Withdrawal by Subject	17	17

Baseline Characteristics

Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention + Usual Care + Developmental Screening Results n=278 Participants 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.	Usual Care + Developmental Screening Results n=281 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.	Total n=559 Participants Total of all reporting groups
Age, Continuous	19.4 Months STANDARD_DEVIATION 8.1 • n=5 Participants	20.6 Months STANDARD_DEVIATION 8.7 • n=7 Participants	20.0 Months STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	123 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	154 Participants n=5 Participants	158 Participants n=7 Participants	312 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	241 Participants n=5 Participants	235 Participants n=7 Participants	476 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	45 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	60 Participants n=7 Participants	123 Participants n=5 Participants
Race (NIH/OMB) More than one race	30 Participants n=5 Participants	41 Participants n=7 Participants	71 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	168 Participants n=5 Participants	163 Participants n=7 Participants	331 Participants n=5 Participants
Region of Enrollment United States	278 participants n=5 Participants	281 participants n=7 Participants	559 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after enrollment

Outcome measures

Outcome measures
Measure	Intervention + Usual Care + Developmental Screening Results n=249 Participants 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.	Usual Care + Developmental Screening Results n=263 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.	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.	High or Moderate Risk - 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. This is a subgroup of children enrolled in usual care who, at baseline, were determined to have a moderate or high risk for developmental delay.
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	16.3 percentage of children	—	—
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	8.8 percentage of children	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention + Usual Care + Developmental Screening Results n=250 Participants 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.	Usual Care + Developmental Screening Results n=249 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.	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.	High or Moderate Risk - 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. This is a subgroup of children enrolled in usual care who, at baseline, were determined to have a moderate or high risk for developmental delay.
Child Developmental Outcomes PEDS DM-AL Expressive Language Standardized Score - Baseline	125.3 Standardized Score Standard Deviation 41.3	125.4 Standardized Score Standard Deviation 40.6	—	—
Child Developmental Outcomes PEDS DM-AL Expressive Language Standardized Score - 24 Months	119.2 Standardized Score Standard Deviation 35.6	117.6 Standardized Score Standard Deviation 41.2	—	—
Child Developmental Outcomes PEDS DM-AL - Receptive Language Standardized Score - Baseline	123.6 Standardized Score Standard Deviation 55.9	124.0 Standardized Score Standard Deviation 50.4	—	—
Child Developmental Outcomes PEDS DM-AL Receptive Language Standardized Score - 24 Months	139.2 Standardized Score Standard Deviation 48.8	137.3 Standardized Score Standard Deviation 50.1	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention + Usual Care + Developmental Screening Results n=249 Participants 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.	Usual Care + Developmental Screening Results n=83 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.	Usual Care + Developmental Screening Results n=263 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.	High or Moderate Risk - Usual Care + Developmental Screening Results n=95 Participants This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. This is a subgroup of children enrolled in usual care who, at baseline, were determined to have a moderate or high risk for developmental delay.
Number of Children Who Have Received Referrals and Number of Children Who Have Received Services Received a referral for intervention services	61 participants	47 participants	43 participants	32 participants
Number of Children Who Have Received Referrals and Number of Children Who Have Received Services Received intervention services	36 participants	30 participants	23 participants	16 participants
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	49 participants	40 participants	16 participants
Number of Children Who Have Received Referrals and Number of Children Who Have Received Services Received early care and education (ECE) services	65 participants	30 participants	27 participants	9 participants

Adverse Events

Intervention + Usual Care + Developmental Screening Results

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care + Developmental Screening Results

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

Dr. Paul Chung, Professor and Principal Investigator

University of California, Los Angeles & Kaiser Permanente School of Medicine

Phone: 626-710-0389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place