Translating Evidence Based Developmental Screening Into Pediatric Primary Care

NCT00844246 | Completed Phase 2

• 1 other identifier: 2008-9-6124
• Study Type: interventional
• Target: 2,314
• Locations: 1 country
• Sites: 4

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.

Conditions

Developmental Delays

Keywords

Developmental delays; Early intervention services

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of children in the study who are referred to Early Intervention Services

  We assessed this in June 2010

• Percentage of children in the study who enroll in Early Intervention Services

  We will assess this between June to October 2010

• 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

Study Arms (3)

SRS

EXPERIMENTAL

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.

Other: Developmental screening using ASQ and MCHAT

Provider

EXPERIMENTAL

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.

Other: Developmental screening using ASQ and MCHAT

Routine

NO INTERVENTION

Subjects randomized to routine surveillance will receive routine preventive care as well as developmental surveillance at all well child visits, including the 9, 18, 24 and 30 month visits. EI referral will be completed, at the discretion of the provider, if the PCP observes a developmental delay during surveillance or the caregivers raise a specific concern about the child's development.

Interventions

Developmental screening using ASQ and MCHAT OTHER

In the SRS intervention arm subjects will complete developmental screening tools with a school readiness specialist at their 9, 18, 24 and 30 month well child visits and then complete their well child visit with their primary care clinician to discuss the results.

SRS

Eligibility Criteria

• Age: Up to 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (4)

CHOP - Primary Care Market Street

Philadelphia, Pennsylvania, 19104, United States

Location

CHOP Primary Care-University City

Philadelphia, Pennsylvania, 19104, United States

Location

CHOP Primary Care Center- Cobbs Creek

Philadelphia, Pennsylvania, 19139, United States

Location

CHOP Primary Care - South Philadelphia

Philadelphia, Pennsylvania, 19145, United States

Location

Study Officials

• James P Guevara, MD MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

US (4)