N/A
N=64
A Family Centered Intervention to Promote Optimal Child Development
Developmental Delays
Bottom Line
View on ClinicalTrials.gov: NCT01941186 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups — 20; 21; 17; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Decision Aid (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups |
20; 21; 17; 17 | — |
| SECONDARY Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention |
48; 35; 6; 10; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01941186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.