Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00844246
First received: February 13, 2009
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Developmental Delays
Other: Developmental screening using ASQ and MCHAT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Translating Evidence Based Developmental Screening Into Pediatric Primary Care ( Aims 2 and 3 )

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of children in the study who are referred to Early Intervention Services [ Time Frame: We assessed this in June 2010 ] [ Designated as safety issue: No ]
  • Percentage of children in the study who enroll in Early Intervention Services [ Time Frame: We will assess this between June to October 2010 ] [ Designated as safety issue: No ]
  • Percent of parents enrolled in the study who report as satisfied with the intervention [ Time Frame: We assessed this between March and September 2010 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 2314
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SRS
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
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.
Experimental: Provider
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
Subjects who are randomized to PCP arm will be screened for developmental delays by their Primary Care Clinician at their 9, 18, 24 and 30 month well child visits. The corresponding screening tools may be mailed to the study participants 2 weeks before the scheduled well child visits. Those who do not complete the screening tools or those who did not receive them in the mail will then complete the questionnaire in the office prior to seeing their doctor or with their doctor. 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 referral will be completed, at the discretion of the provider with the approval of the caregiver , if the subject fails the developmental screen or the caregivers raise a specific concern about the child's development.
No Intervention: Routine
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.

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

Ages Eligible for Study:   up to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844246

Locations
United States, Pennsylvania
CHOP - Primary Care Market Street
Philadelphia, Pennsylvania, United States, 19104
CHOP Primary Care - South Philadelphia
Philadelphia, Pennsylvania, United States, 19145
CHOP Primary Care Center- Cobbs Creek
Philadelphia, Pennsylvania, United States, 19139
CHOP Primary Care-University City
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: James P Guevara, MD MPH Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00844246     History of Changes
Other Study ID Numbers: 2008-9-6124
Study First Received: February 13, 2009
Last Updated: November 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Developmental delays
Early intervention services

ClinicalTrials.gov processed this record on November 27, 2014