Feasibility Study of SPEEDI (SPEEDI)

August 21, 2023 updated by: Virginia Commonwealth University

Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm

The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
  • medically stable,
  • off ventilator support,
  • demonstrate thermoregulation in an open crib by 35 weeks of PMA,
  • live within 60 minutes of the hospital, and
  • have one parent who is English speaking and willing to participate in the study intervention and assessments

Exclusion Criteria:

  • genetic syndrome or
  • musculoskeletal deformity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Intervention group
Intervention with SPEEDI
Behavioral: SPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Other Names:
  • Developed for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Infant Motor Performance
Time Frame: Change from baseline to the end of intervention at 3 months of adjusted age
Assessment of motor development
Change from baseline to the end of intervention at 3 months of adjusted age
Problem Solving Behaviors
Time Frame: end of intervention at 3 months of adjusted age
Early infant problem solving
end of intervention at 3 months of adjusted age
Reaching
Time Frame: end of intervention at 3 months of adjusted age
Reaching and object interaction measures
end of intervention at 3 months of adjusted age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Child Interactions
Time Frame: End of intervention at 3 months of adjusted age
Behavioral coding of parent child interactions
End of intervention at 3 months of adjusted age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimated)

June 28, 2013

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCU_HM13949

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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