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Enriched Education Program for Infant Development

N/A

Waitlist Available

Led By Michele A Lobo, PT, PhD

Research Sponsored by University of Delaware

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 reported at baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)

Awards & highlights

Study Summary

This trial will compare two different ways of teaching parents how to play with their infants, to see if it affects the infant's development or the caregiver's characteristics.

Eligible Conditions

Infant Development
Developmental Delay

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ reported at baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~reported at baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first)

This trial's timeline: 3 weeks for screening, Varies for treatment, and reported at baseline (start of study) and reported at 1 month- intervals through the onset of independent walking (typically 12 -15 months) or when the child reaches 24 months of age (whichever occurs first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Infant Developmental Outcomes

Change in Infant Motor Development

Change in Parental Play Behaviors: Communication

+4 more

Secondary outcome measures

Change in Daily Positioning

Change in Infant Object Exploration

Change in Language Development

+6 more

Other outcome measures

Affordances in the Home Environment Impact Child Developmental Outcomes and Parental Characteristics

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Typical Development, Enriched Education ProgramExperimental Treatment1 Intervention

Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development.

Group II: Developmental Delay, Enriched Education ProgramExperimental Treatment1 Intervention

Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive enriched play activity education based on key ingredients evidenced to advance infant development.

Group III: Typical Development, Typical Education ProgramActive Control1 Intervention

Parents of infants with typical development (i.e, not meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books.

Group IV: Developmental Delay, Typical Education ProgramActive Control1 Intervention

Parents of infants with/at risk for developmental delay (i.e, meeting the eligibility criteria for early intervention services in the state of Delaware) will receive typical play education based on usual education found in commonly used websites, apps, and books.

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Who is running the clinical trial?

University of DelawareLead Sponsor

154 Previous Clinical Trials

25,162 Total Patients Enrolled

3 Trials studying Infant Development

399 Patients Enrolled for Infant Development

Michele A Lobo, PT, PhDPrincipal InvestigatorUniversity of Delaware

2 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Enriched Education Program Clinical Trial Eligibility Overview. Trial Name: NCT05259423 — N/A

Infant Development Research Study Groups: Typical Development, Enriched Education Program, Typical Development, Typical Education Program, Developmental Delay, Enriched Education Program, Developmental Delay, Typical Education Program

Infant Development Clinical Trial 2023: Enriched Education Program Highlights & Side Effects. Trial Name: NCT05259423 — N/A

Enriched Education Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259423 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results are scientists hoping to observe from this trial?

"This experiment is tracking the primary outcome of Change in Infant Motor Development at Baseline and 1, 2, 3 & 6 months. Additionally, secondary outcomes include Change in Language Development (utilizing The Preschool Language Scales-5th Edition), Change in Infant Object Exploration (assessed with an Object Exploration Assessment) and Change in Parental Practices regarding motor development (measured using a Motor Habits Questionnaire)."

Answered by AI

What is the current population size of participants in this investigation?

"Yes, reliable reports from clinicaltrials.gov demonstrate that this medical trial is still ongoing as of May 16th 2022 and seeking participants. The original posting was made on April 1st 2022, with the goal being to recruit 40 patients from a single location."

Answered by AI

Are new participants being accepted for the research project presently?

"The clinical trial is currently welcoming participants, as per information hosted on clinicaltrials.gov. This medical study was initiated in April of 2022 and most recently amended in May of the same year."

Answered by AI

Is the age range for this clinical trial restricted to individuals over 25 years of age?

"As outlined in the trial's criteria for eligibility, participants must fall between 1 and 24 months of age."

Answered by AI

What are the eligibility requirements to participate in this trial?

"This clinical trial is enrolling 40 infants, aged between one month and two years, experiencing early development. For inclusion in the study, these children must be younger than six months at registration; have a parent who can physically participate in play activities with them (e.g., carrying them and playing on the floor); meet Delaware's state-level Early Intervention Inclusion Criteria such as chromosomal disorders or developmental delay measured by standardized assessments; be able to engage in data collection activities via either virtual or physical visits; have an English-speaking guardian over 18 years of age with access to Zoom/internet if they are participating virtually; and not"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects on Children and Parents of Educating Parents About Ways to Play With Babies

Michele Lobo 2022. "The Effects on Children and Parents of Educating Parents About Ways to Play With Babies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05259423.