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Completed

NCT Number: NCT00844246

Translating Evidence Based Developmental Screening Into Pediatric Primary Care

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.

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Key information

Conditions

Developmental Delays

Age range

Up to 30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHOP - Primary Care Market Street, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

    Time frame: We assessed this between June to October 2010

Secondary outcomes

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

    Time frame: We assessed this in June 2010

  2. Percentage of children in the study who enroll in Early Intervention Services

    Time frame: We will assess this between June to October 2010

  3. Percent of parents enrolled in the study who report as satisfied with the intervention

    Time frame: We assessed this between March and September 2010

  4. Percent of providers enrolled in the study who report as satisfied with the intervention.

    Time frame: We will assess this between March and September 2010

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )

Acronym: TEDS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 16, 2009
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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