Premature
Conditions
Keywords
Premature, Development, Motor, Cognitive, Parent
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.
Interventions
BEHAVIORALSPEEDI
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 34 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test of Infant Motor Performance | Change from baseline to the end of intervention at 3 months of adjusted age | Assessment of motor development |
| Problem Solving Behaviors | end of intervention at 3 months of adjusted age | Early infant problem solving |
| Reaching | end of intervention at 3 months of adjusted age | Reaching and object interaction measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Child Interactions | End of intervention at 3 months of adjusted age | Behavioral coding of parent child interactions |
Countries
United States
Outcome results
None listed