Feasibility Study of SPEEDI

Phase 1

Completed

• Conditions: Premature
• Interventions: Behavioral: SPEEDI

• Registration Number: NCT01889108
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	SPEEDI	Intervention with SPEEDI

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Parent Child Interactions	End of intervention at 3 months of adjusted age	Behavioral coding of parent child interactions

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States