Translating Evidence Based Developmental Screening Into Pediatric Primary Care

Phase 2

Completed

• Conditions: Developmental Delays
• Interventions: Other: Developmental screening using ASQ and MCHAT

• Registration Number: NCT00844246
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2314

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SRS	Developmental screening using ASQ and MCHAT	School Readiness Specialist (SRS) will administer the screening questionnaire to the subject during the intervention period, at the subject's 9, 18, 24 and 30 month visits. They will then see their PCP for a well child visit in which the results of the test will be interpreted, developmental counseling and/or anticipatory guidance provided as per usual care. EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
Provider	Developmental screening using ASQ and MCHAT	Primary Care Physician (PCP) will do the developmental screening at the subject's 9, 18, 24 and 30 month well child visits. Once the screening questionnaire is complete the PCP will then score the screening tool and interpret the test results. Developmental counseling and/or anticipatory guidance will be provided, as per usual care. EI (Early intervention) referral will be completed, at the discretion of the providers, if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.

Primary Outcome Measures

Name	Time	Method
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.	We assessed this between June to October 2010

Secondary Outcome Measures

Name	Time	Method
Percent of parents enrolled in the study who report as satisfied with the intervention	We assessed this between March and September 2010
Percent of providers enrolled in the study who report as satisfied with the intervention.	We will assess this between March and September 2010
Percentage of children in the study who enroll in Early Intervention Services	We will assess this between June to October 2010
Percentage of children in the study who are referred to Early Intervention Services	We assessed this in June 2010

Trial Locations

Locations (4)

CHOP Primary Care - South Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

CHOP - Primary Care Market Street; 🇺🇸 Philadelphia, Pennsylvania, United States

CHOP Primary Care-University City; 🇺🇸 Philadelphia, Pennsylvania, United States

CHOP Primary Care Center- Cobbs Creek; 🇺🇸 Philadelphia, Pennsylvania, United States