A Family Centered Intervention to Promote Optimal Child Development

• ClinicalTrials.gov Identifier: NCT01941186
• Recruitment Status: Completed
• First Posted: September 13, 2013
• Results First Posted: August 30, 2016
• Last Update Posted: October 21, 2016
• Sponsor: Children's Hospital of Philadelphia
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Developmental Delays	Other: Patient Decision Aid	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
• Study Start Date: December 2013
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention [ Time Frame: Up to 7 days ]
   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.

Other Outcome Measures:

1. Parent Uncertainty About Early Intervention [ Time Frame: Up to 7 days ]
   Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
2. Parental Predisposition for Early Intervention [ Time Frame: Up to 7 days ]
   Parental predisposition for early intervention services will be measured using surveys.
3. Feasibility of the Patient Decision Aid [ Time Frame: Up to 7 days ]
   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.
4. Acceptability of the Patient Decision Aid for Early Intervention Referral [ Time Frame: Up to 7 days ]
   The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.

Eligibility Criteria

• Ages Eligible for Study: up to 36 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

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

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT01941186
• Other Study ID Numbers: 13-010441
• First Posted: September 13, 2013
• Results First Posted: August 30, 2016
• Last Update Posted: October 21, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Children's Hospital of Philadelphia:

Children; Developmental Delays; Early Intervention (EI); Patient Decision Aid (PDA)