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
|Condition or disease||Intervention/treatment||Phase|
|Developmental Delays||Other: Patient Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|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|
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.
- 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.
- 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.
- 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.
- Parental Predisposition for Early Intervention [ Time Frame: Up to 7 days ]Parental predisposition for early intervention services will be measured using surveys.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941186
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Alexander Fiks, MD, MSCE||Children's Hospital of Philadelphia|
|Principal Investigator:||Manuel Jimenez, MD, MS||Children's Hospital of Philadelphia|