Translating Evidence Based Developmental Screening Into Pediatric Primary Care (TEDS)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 2

Conditions: Developmental Delays

Treatments: Other: Developmental screening using ASQ and MCHAT

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00844246

2008-9-6124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,314 patients

Sex: All

Ages: Under 30 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,314 participants in 3 patient groups

SRS

Experimental group

Description:

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.

Treatment:

Other: Developmental screening using ASQ and MCHAT

Other: Developmental screening using ASQ and MCHAT

Provider

Experimental group

Description:

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.

Treatment:

Other: Developmental screening using ASQ and MCHAT

Other: Developmental screening using ASQ and MCHAT

Routine

No Intervention group

Description:

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.