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Family Navigator for Developmental Delay and Child Development (ODEI Trial)
N/A
Waitlist Available
Led By James Guevara, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ODEI Trial Summary
This trial will test if a patient navigation intervention can help poor urban minority children in Philadelphia access and complete early intervention services, which are publicly funded and can improve child development.
Eligible Conditions
- Developmental Delay
- Child Development
ODEI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation of the child's Cognitive functioning (i.e., sensorimotor development, problem solving skills)
Secondary outcome measures
Early Intervention Referral Completion
Early Intervention Services Completion
Evaluation of the child's Social-Emotional functioning (i.e. self regulation, emotional skills)
+3 moreOther outcome measures
An evaluation of Parent/Family Engagement in the Early Intervention process
Measure of adversity experienced in childhood
ODEI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Family Navigator (Intervention)Experimental Treatment1 Intervention
Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services.
Group II: Usual Care (Control)Active Control1 Intervention
Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,915 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,215,851 Total Patients Enrolled
James Guevara, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Parents speak English or Spanish.The child has a condition since birth, genetic syndrome or HIV that may cause slow growth or development.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care (Control)
- Group 2: Family Navigator (Intervention)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it currently feasible for participants to enroll in this experiment?
"As per the clinicaltrials.gov database, this medical trial has ceased recruitment and is not actively seeking participants. Initially posted on September 11th 2018, it was most recently updated on June 1st 2022. Despite there being 65 other trials currently accepting patients, this one is no longer doing so at present."
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