A Family Centered Intervention to Promote Optimal Child Development

Study Overview
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Brief Summary
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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.

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

Conditions
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Developmental Delays

Intervention / Treatment
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* Other: Patient Decision Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Decision Aid<br>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<br>* 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.<br>|
| No Intervention: Routine Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Developmental Delays, Early Intervention (EI), Patient Decision Aid (PDA)