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Clinical Trials/NCT01941186
NCT01941186
Completed
N/A

A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community

Children's Hospital of Philadelphia1 site in 1 country64 target enrollmentDecember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Developmental Delays
Sponsor
Children's Hospital of Philadelphia
Enrollment
64
Locations
1
Primary Endpoint
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home. Subjects will be randomized to one of two study arms- (1) intervention (2) control condition. Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
  • Caregivers able to give permission (informed consent).

Exclusion Criteria

  • Primary language other than English
  • Children already enrolled in early intervention

Outcomes

Primary Outcomes

Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups

Time Frame: Up to 1 year after randomization

Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.

Secondary Outcomes

  • Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention(Up to 7 days)

Study Sites (1)

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