A Family Centered Intervention to Promote Optimal Child Development

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

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 Overview

• Status: Completed
• Conditions: Developmental Delays
• Intervention / Treatment: Other: Patient Decision Aid

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Decision Aid; After 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.	Other: Patient Decision Aid; 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.
No Intervention: Routine Care; After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Uncertainty About Early Intervention	Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.	Up to 7 days
Parental Predisposition for Early Intervention	Parental predisposition for early intervention services will be measured using surveys.	Up to 7 days
Feasibility of the Patient Decision Aid	The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.	Up to 7 days
Acceptability of the Patient Decision Aid for Early Intervention Referral	The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.	Up to 7 days

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Alexander Fiks, MD, MSCE, Children's Hospital of Philadelphia; Principal Investigator: Manuel Jimenez, MD, MS, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Children; Developmental Delays; Early Intervention (EI); Patient Decision Aid (PDA)
• Other Study ID Numbers: 13-010441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO