A Family Centered Intervention to Promote Optimal Child Development

Developmental Delays Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01941186
• Other study ID #: 13-010441
• Status: Active, not recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: January 4, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Developmental Delays

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Parental Predisposition for Early Intervention	Parental predisposition for early intervention services will be measured using surveys.	Up to 7 days	No
Other	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	No
Other	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 14 days	No
Primary	Evaluation by Early Intervention Specialists	The primary objective of this study is to determine the effectiveness of a patient decision aid and text message reminder on increasing early intervention referral completion. This will be measured by determining the number of subjects who receive a multi-disciplinary evaluation from the early intervention agency.	Up to 180 days	No
Secondary	Parental Attitudes and Knowledge of Early Intervention	Parental knowledge and attitudes will be measured quantitatively using Likert-scale surveys.	Up to 7 days	No