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A Family Centered Intervention to Promote Optimal Child Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01941186
First received: September 9, 2013
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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 Intervention
Developmental Delays
Other: Patient Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Parent Uncertainty About Early Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.

  • Parental Predisposition for Early Intervention [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Parental predisposition for early intervention services will be measured using surveys.

  • Feasibility of the Patient Decision Aid [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    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.

  • Acceptability of the Patient Decision Aid for Early Intervention Referral [ Time Frame: Up to 14 days ] [ Designated as safety issue: No ]
    The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.


Enrollment: 64
Study Start Date: December 2013
Study Completion Date: July 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 36 Months   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941186

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     History of Changes
Other Study ID Numbers: 13-010441 
Study First Received: September 9, 2013
Results First Received: July 13, 2016
Last Updated: July 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Children's Hospital of Philadelphia:
Children
Developmental Delays
Early Intervention (EI)
Patient Decision Aid (PDA)

ClinicalTrials.gov processed this record on September 29, 2016