A Family Centered Intervention to Promote Optimal Child Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01941186
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : August 30, 2016
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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 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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01941186

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Principal Investigator: Alexander Fiks, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Manuel Jimenez, MD, MS Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT01941186     History of Changes
Other Study ID Numbers: 13-010441
First Posted: September 13, 2013    Key Record Dates
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:
Developmental Delays
Early Intervention (EI)
Patient Decision Aid (PDA)