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

Primary Purpose

Infant, Premature, Diseases, Brain White Matter Disease Periventricular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPEEDI Intervention
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases

Eligibility Criteria

undefined - 18 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Genetic syndromes or musculoskeletal deformities

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care Group

SPEEDI Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reaching (Toy Contact Duration)
Duration the infant is in contact with the target is used to quantify changes in reaching.
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.

Secondary Outcome Measures

Early Feeding Skill Assessment (FES)
The Early Feeding Skills (EFS) was used to assess the infant's oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.
Parent Child Early Relational Assessment (PCERA)
The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).
Bayley Scales of Infant and Toddler Development (Bayley).
The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.
Test of Infant Motor Performance (TIMP)
The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.

Full Information

First Posted
May 27, 2014
Last Updated
January 3, 2018
Sponsor
Virginia Commonwealth University
Collaborators
Foundation for Physical Therapy, Inc., Children's Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02153736
Brief Title
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
Acronym
SPEEDI
Official Title
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Foundation for Physical Therapy, Inc., Children's Hospital Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Brain White Matter Disease Periventricular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
This group of subjects will receive usual care provided in the medial system and community.
Arm Title
SPEEDI Intervention
Arm Type
Experimental
Arm Description
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
Intervention Type
Behavioral
Intervention Name(s)
SPEEDI Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reaching (Toy Contact Duration)
Description
Duration the infant is in contact with the target is used to quantify changes in reaching.
Time Frame
1 month post intervention
Title
Early Problem Solving Indicator (EPSI)
Description
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.
Time Frame
End of intervention, 1 and 3 months post intervention
Secondary Outcome Measure Information:
Title
Early Feeding Skill Assessment (FES)
Description
The Early Feeding Skills (EFS) was used to assess the infant's oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.
Time Frame
Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
Title
Parent Child Early Relational Assessment (PCERA)
Description
The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).
Time Frame
Baseline, End phase 1, End of intervention, 1 month post intervention
Title
Bayley Scales of Infant and Toddler Development (Bayley).
Description
The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.
Time Frame
3 month post intervention
Title
Test of Infant Motor Performance (TIMP)
Description
The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.
Time Frame
Baseline to End of intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Genetic syndromes or musculoskeletal deformities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey C Dusing, PhD PT
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Given the small sample from a specific time range the data will not be shared due to difficulty de-identifying with demographics of individual infants attached.
Citations:
PubMed Identifier
29426320
Citation
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.
Results Reference
derived

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

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