Clinical trial NCT00844246: Translating Evidence Based Developmental Screening Into Pediatric Primary Care
Official title: Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Developmental Delays
Keywords: Developmental delays
Early intervention services
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2009-02-16
Enrollment: 2314
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.

Detailed description: The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age. The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.

Eligibility criteria: Inclusion Criteria:

1. Age birth to 30 months of age by the start of the intervention phase.
2. Child's Primary Care Physician has consented to participate in the study
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Premature Infants (less than 36 weeks of gestation)
2. Children with prior identified developmental delay.
3. Children with major congenital anomalies/genetic disorders
4. Children placed in foster care

Primary outcomes:
measure: The primary outcome measure for this study will be the percentage of children enrolled in the study who are identified as having a developmental delay.
timeFrame: We assessed this between June to October 2010
Secondary outcomes:
measure: Percentage of children in the study who are referred to Early Intervention Services
timeFrame: We assessed this in June 2010
measure: Percentage of children in the study who enroll in Early Intervention Services
timeFrame: We will assess this between June to October 2010
measure: Percent of parents enrolled in the study who report as satisfied with the intervention
timeFrame: We assessed this between March and September 2010
measure: Percent of providers enrolled in the study who report as satisfied with the intervention.
timeFrame: We will assess this between March and September 2010
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CHOP - Primary Care Market Street
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care-University City
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care Center- Cobbs Creek
state: Pennsylvania
city: Philadelphia
country: United States
facility: CHOP Primary Care - South Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James P Guevara, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: