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

NCT02153736 | Completed Results

• 1 other identifier: HM20001308
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature, Diseases; Brain White Matter Disease Periventricular

Outcome Measures

Primary Outcomes (2)

• Reaching (Toy Contact Duration)

  Duration the infant is in contact with the target is used to quantify changes in reaching.

  1 month post intervention

• Early Problem Solving Indicator (EPSI)

  Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.

  End of intervention, 1 and 3 months post intervention

Secondary Outcomes (4)

• Early Feeding Skill Assessment (FES)

  Baseline, End phase 1, End of intervention, 1 and 3 months post intervention

• Parent Child Early Relational Assessment (PCERA)

  Baseline, End phase 1, End of intervention, 1 month post intervention

• Bayley Scales of Infant and Toddler Development (Bayley).

  3 month post intervention

• Test of Infant Motor Performance (TIMP)

  Baseline to End of intervention

Study Arms (2)

Usual Care Group

NO INTERVENTION

This group of subjects will receive usual care provided in the medial system and community.

SPEEDI Intervention

EXPERIMENTAL

This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.

Behavioral: SPEEDI Intervention

Interventions

SPEEDI Intervention BEHAVIORAL

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.

SPEEDI Intervention

Eligibility Criteria

• Age: Up to 18 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• born extremely preterm (˂29 weeks of gestation) OR 10 born preterm and diagnosed with a neonatal brain injury including intraventricular hemorrhage grade 3 or 4, periventricular white matter injury, or hydrocephalus requiring a shunt.
• Medically stable by 40 weeks of gestation, including being off ventilator support
• Live within 50 minutes of the hospital.
• English Speaking mother
• Mother willing and able to participate in the study with the infant subject

You may not qualify if:

• Genetic syndromes or musculoskeletal deformities

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Foundation for Physical Therapy, Inc.: collaborator
• Children's Hospital Foundation: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Dusing SC, Tripathi T, Marcinowski EC, Thacker LR, Brown LF, Hendricks-Munoz KD. Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial. BMC Pediatr. 2018 Feb 9;18(1):46. doi: 10.1186/s12887-018-1011-4.

  PMID: 29426320 DERIVED

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Sample smaller than anticipated Fewer infant with brain injury than anticipated ceiling effect notes with reaching measures longer term outcomes only possible from clinical records

Results Point of Contact

• Title: Stacey Dusing, PT, PhD, PCS, Director Motor Development Lab
• Organization: Virginia Commonwealth University

scdusing@vcu.edu

804-628-3632

Study Officials

• Stacey C Dusing, PhD PT

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 29, 2018
• Results First Posted: September 18, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)