NCT02153736

Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention

Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Weeks
• Healthy volunteers: Not accepted

Summary

The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care.

Detailed description

The primary aims of this randomized controlled trial are to evaluate efficacy potential of SPEEDI at enhancing reaching and play based problem solving compared to infants receiving usual care. The secondary aim is to assess the efficacy potential of SPEEDI to impact motor and cognitive development as assessed using commonly used clinical outcome measures. The exploratory aims are to assess the impact of SPEEDI on parent child interactions and feeding skills. The findings will provide crucial initial efficacy estimates to be used in a larger definitive clinical trial of SPEEDI.

Conditions

• Infant, Premature, Diseases
• Brain White Matter Disease Periventricular

Interventions

Type	Name	Description
BEHAVIORAL	SPEEDI Intervention	Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-06-03
• Last updated: 2018-01-29
• Results posted: 2017-09-18

Locations

1 site across 1 country: United States