A Family Centered Intervention to Promote Optimal Child Development

N/ACompletedNCT01941186

Children's Hospital of Philadelphia64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Developmental Delays

Interventions

Patient Decision AidOTHER

Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.

Eligibility

Sex: ALLMin age: 2 DaysMax age: 36 Months

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 1 year after randomization

Secondary Outcomes

Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention

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.

Time frame: Up to 7 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.