Trial Outcomes & Findings for The Opening Doors to Early Intervention Study (NCT NCT03625115)

Last Updated: 2025-02-10

Results Overview

The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a validated assessment of infant and toddler development for use with 1-42 month olds. The Cognitive domain consists of developmental play tasks that are administered to obtain a developmental quotient in order to determine the child's level of cognitive functioning. The composite score of the Cognitive domain is derived from a single scaled test score from the Cognitive Scale (as opposed to being comprised of the summation of scaled scores from multiple subscales, such as with the BSID-III Language and Motor composite scores). The total composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.

Recruitment status

COMPLETED

Study phase

Target enrollment

357 participants

Primary outcome timeframe

12 months

Results posted on

2025-02-10

Participant Flow

357 parent/child dyads were enrolled in the main RCT and provided their information for data analyses. A dyad refers to one parent and one child who were enrolled in the study.

We are reporting on participant data from 357 participants, 174 in the control arm and 183 in the intervention arm.

Participant milestones

Participant milestones
Measure	Usual Care (Control) Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Overall Study STARTED	174	183
Overall Study COMPLETED	153	152
Overall Study NOT COMPLETED	21	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care (Control) Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Overall Study Withdrawal by Subject	4	7
Overall Study Lost to Follow-up	17	24

Baseline Characteristics

The Opening Doors to Early Intervention Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care (Control) n=174 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=183 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.	Total n=357 Participants Total of all reporting groups
Age, Continuous	30.9 years STANDARD_DEVIATION 6.7 • n=5 Participants	30.9 years STANDARD_DEVIATION 7.0 • n=7 Participants	30.9 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	172 Participants n=7 Participants	334 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	166 Participants n=7 Participants	324 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	111 Participants n=5 Participants	136 Participants n=7 Participants	247 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	28 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	174 participants n=5 Participants	183 participants n=7 Participants	357 participants n=5 Participants
Caregiver Education Level Less than high school	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Caregiver Education Level High school and/or some college	110 Participants n=5 Participants	132 Participants n=7 Participants	242 Participants n=5 Participants
Caregiver Education Level College or graduate degree	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Caregiver income $14,999 or less	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Caregiver income $15,000 - $34,999	58 Participants n=5 Participants	68 Participants n=7 Participants	126 Participants n=5 Participants
Caregiver income $35,000 - 54,999	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Caregiver income $55,000 or more	37 Participants n=5 Participants	45 Participants n=7 Participants	82 Participants n=5 Participants
Caregiver income information not provided	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Caregiver Marital Status Single	79 Participants n=5 Participants	97 Participants n=7 Participants	176 Participants n=5 Participants
Caregiver Marital Status Separated or Divorced	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Caregiver Marital Status Living Together As if Married or Married	90 Participants n=5 Participants	81 Participants n=7 Participants	171 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: A total of 223 participants completed the cognitive section of the Bayley III assessment. The reason why this number is not equal to 357 is because some families were unable to make it in person for the assessment or the assessment could not have been completed due to child behavior.

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=107 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=116 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills)	83.50 score on a scale Interval 55.0 to 115.0	81.94 score on a scale Interval 55.0 to 110.0

PRIMARY outcome

Timeframe: up to 12 months

Population: We were only able to collect data from 347 participants. The reason this number does not equal 357 participants is due to participants dropping out or being withdrawn from the study before we collected early intervention data from their provider's entities.

Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE).

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=170 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=177 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Early Intervention Referral Completion MDE Completed	114 Participants	143 Participants
Early Intervention Referral Completion MDE Not Completed	56 Participants	34 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: 207 participants were analyzed; this number came from the 207 participants who had completed their EI referral AND had been eligible for EI services or regular tracking. 200 for eligible for early intervention services and 7 were eligible for developmental tracking every 3 months.

Initiation of early intervention services if deemed eligible for services, defined as participants who started services.

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=93 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=114 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Early Intervention Services Initiation Started EI Services	88 Participants	107 Participants
Early Intervention Services Initiation Did not Start EI Services	5 Participants	7 Participants

PRIMARY outcome

Timeframe: 12 months

Population: A total of 220 participants completed the language section of the Bayley III assessment. The reason why this number is not equal to 357 is because some families were unable to make it in person for the assessment or the assessment could not have been completed due to child behavior.

The BSID-III language scale will be used to assess both the understanding of language (receptive language) and use or expression of language (expressive language) skills, such as following simple directions, and naming or identifying objects and pictures. The total composite score of the Language functioning domain is composed of the sum of both the Receptive Language and the Expressive Language subscales' scaled scores. The total Language composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=107 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=113 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities)	79.39 score on a scale Interval 47.0 to 118.0	78.71 score on a scale Interval 47.0 to 132.0

SECONDARY outcome

Timeframe: up to 12 months

Population: This analysis includes participants who were randomized into a study condition. Three participants were withdrawn immediately after enrollment, leaving a total of 357 participants randomized.

Changes in state policy regarding early intervention services. During the time of the study, the COVID-19 pandemic began, which affected early intervention services and policies. This timeline is broken down into the following time periods. Period 1-Early Intervention in person pre pandemic: Study start date - March 19th, 2020 Period 2-Early Intervention complete closure: March 20th, 2020 - early April 2020 Period 3: Early Intervention Virtual Only: early April 2020 - June 2nd, 2020 Period 4: Early Intervention Hybrid: June 3rd, 2020 - current (in line with Governor Wolf's process to reopen plan, this was when services and evaluations were done both virtually and in person)

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=174 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=183 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Public Policy Changes Participants enrolled during Period 3	0 Participants	0 Participants
Public Policy Changes Participants enrolled during Period 1	60 Participants	65 Participants
Public Policy Changes Participants enrolled during Period 2	0 Participants	0 Participants
Public Policy Changes Participants enrolled during Period 4	114 Participants	118 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 months

Population: This data came from participants who had completed the parent engagement questionnaire at the 3 month follow up timepoints. Not all participants completed this survey, which is why the total number of participants analyzed is 333 and not 357.

Scale Name: Parent Early Intervention (EI) Engagement Questionnaire Description: Modified and validated version of the Client Engagement in Child Protective Services (CECPS) questionnaire which evaluates the caregiver(s) perceived extent of involvement, in the early intervention process. Scale Ranges: 9 items, split up in to 3 factors/categories, are scored on a likert scale from 1-5. Two items are reverse scored during analysis. 1 indicates poor engagement (poor outcome) and 5 indicates high engagement (high outcome). Each item can be scored 1-5. When items are analyzed by factor/category, the average is taken from all items in that factor/category (can be anywhere in the range of 1-5).

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=168 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=165 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
An Evaluation of Parent/Family Engagement in the Early Intervention Process Factor 1	4.16 score on a scale Standard Deviation 1.01	4.18 score on a scale Standard Deviation 1.07
An Evaluation of Parent/Family Engagement in the Early Intervention Process Factor 2	4.68 score on a scale Standard Deviation .77	4.68 score on a scale Standard Deviation .85
An Evaluation of Parent/Family Engagement in the Early Intervention Process Factor 3	3.74 score on a scale Standard Deviation 1.09	3.98 score on a scale Standard Deviation 1.11

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 months

Population: 312 families completed the ACES survey. Some families did not complete this self-report measure, which is why this number is less than 357.

Scale Name: Adverse Childhood Experiences (ACEs) Scale Ranges: 0-19, average total score is reported Higher values indicate more risk (worse outcome) and lower values indicate less risk (better out ones).

Outcome measures

Outcome measures
Measure	Usual Care (Control) n=156 Participants Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.	Family Navigator (Intervention) n=156 Participants Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services. Family Navigator (FN): The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
Measure of Adversity Experienced in Childhood	4.44 score on a scale Interval 0.0 to 19.0	4.11 score on a scale Interval 0.0 to 19.0

Adverse Events

Usual Care (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Navigator (Intervention)

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. James Guevara

Children's Hospital of Philadelphia

Phone: 2155901130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place