Translating Evidence Based Developmental Screening Into Pediatric Primary Care

Developmental Delays Clinical Trial

— TEDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00844246
• Other study ID #: 2008-9-6124
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2009
• Last updated: November 8, 2011
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2011
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2314
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Developmental Delays

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	CHOP - Primary Care Market Street	Philadelphia	Pennsylvania
United States	CHOP Primary Care - South Philadelphia	Philadelphia	Pennsylvania
United States	CHOP Primary Care Center- Cobbs Creek	Philadelphia	Pennsylvania
United States	CHOP Primary Care-University City	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of children in the study who are referred to Early Intervention Services		We assessed this in June 2010	No
Secondary	Percentage of children in the study who enroll in Early Intervention Services		We will assess this between June to October 2010	No
Secondary	Percent of parents enrolled in the study who report as satisfied with the intervention		We assessed this between March and September 2010	No
Secondary	Percent of providers enrolled in the study who report as satisfied with the intervention.		We will assess this between March and September 2010	No