Development, Child Clinical Trial
— ODEIOfficial title:
Reducing Disparities in Early Intervention Use: The Opening Doors to Early Intervention Study
Verified date | May 2023 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Poor urban minority children often experience delays in their early development leading to health disparities. Publicly funded early intervention services are available to improve child development among these children in Philadelphia, but few children access and complete these services. This can be due to parents misunderstanding what the services include or may be due to difficulties parents experience in overcoming barriers to participating. This study will test the effectiveness of the Opening Doors to Early Intervention Program, a patient navigation intervention designed to improve families' engagement with early intervention services and overcome barriers to access these services, on early child development.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 29 Months |
Eligibility | Inclusion Criteria: - Child is <30 months old at time of enrollment - Child was born >35 weeks estimated gestational age - Parent-child dyad reside in Philadelphia and present at a Children's Hospital of Philadelphia (CHOP) primary care practice located in Philadelphia - Parents are English or Spanish speaking - Child has recently been referred to the Philadelphia Infant Toddler Early Intervention Program in Philadelphia County Exclusion Criteria: - Child moves outside of Philadelphia County - Child has received EI services in the past 2 weeks - Child has congenital anomalies, genetic syndromes, or human immunodeficiency virus (HIV) that place them at risk of developmental delays |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | An evaluation of Parent/Family Engagement in the Early Intervention process | Evaluation of the parent(s) and/or family's engagement, or perceived extent of involvement, in the early intervention process. A modified and adapted version of the Client Engagement in Child Protective Services (CECPS) questionnaire, a validated measure of family engagement in child welfare services, will be used to assess parent/family engagement. | up to 12 months | |
Other | Measure of adversity experienced in childhood | Self-report measure of adverse childhood events | up to 12 months | |
Primary | Evaluation of the child's Cognitive functioning (i.e., sensorimotor development, problem solving skills) | 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. | 12 months | |
Secondary | Evaluation of the child's overall Motor functioning (Fine Motor and Gross Motor skills) | BSID-III motor functioning scale will be used to assess Fine Motor and Gross Motor skills such as manipulating small objects, stacking blocks, sitting, walking, and climbing stairs. The composite score of the Motor functioning domain is composed of the sum of both the Fine Motor and Gross Motor subscales' scaled scores.The total Motor 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. | 12 months | |
Secondary | Evaluation of the child's overall Language functioning (Receptive and Expressive Language skills and abilities) | 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. | 12 months | |
Secondary | Evaluation of the child's Social-Emotional functioning (i.e. self regulation, emotional skills) | The BSID-III social-emotional functioning scale is a parent-report measure in the format of a questionnaire. This scale will be used to assess the parent's report about the child's behaviors related to ease of calming, social responsiveness, imitation play, and adaptive behaviors. The total Social-Emotional 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. | 12 months | |
Secondary | Early Intervention Referral Completion | Completion of early intervention referrals. | up to 12 months | |
Secondary | Early Intervention Services Completion | Completion of early intervention services if deemed eligible for services. | up to 12 months | |
Secondary | Public Policy Changes | Changes in state policy regarding early intervention services. | up to 12 months |
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