A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 2 Days to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Patient Decision Aid (Other)
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.
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)