Feasibility Study of SPEEDI

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature

Intervention / Treatment
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* Behavioral: SPEEDI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Intervention group<br>Intervention with SPEEDI | Behavioral: SPEEDI<br>* Behavior intervention combining parent education and physical therapy intervention for preterm infants<br>* Other names: Developed for this study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of Infant Motor Performance | Assessment of motor development | Change from baseline to the end of intervention at 3 months of adjusted age | 
| Problem Solving Behaviors | Early infant problem solving | end of intervention at 3 months of adjusted age | 
| Reaching | 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 | Behavioral coding of parent child interactions | End of intervention at 3 months of adjusted age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature, Development, Motor, Cognitive, Parent