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A Family Centered Intervention to Promote Optimal Child Development

Not Applicable
Completed
Conditions
Developmental Delays
Interventions
Other: Patient Decision Aid
Registration Number
NCT01941186
Lead Sponsor
Children's Hospital of Philadelphia
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
64
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Patient Decision AidPatient Decision AidAfter positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
Primary Outcome Measures
NameTimeMethod
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment GroupsUp 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 Outcome Measures
NameTimeMethod
Change in Parental Knowledge and Attitudes From Pre- to Post-InterventionUp to 7 days

Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

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