- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153736
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI)
January 3, 2018 updated by: Virginia Commonwealth University
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) - Phase 1 Clinical Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care Group
This group of subjects will receive usual care provided in the medial system and community.
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Experimental: SPEEDI Intervention
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaching (Toy Contact Duration)
Time Frame: 1 month post intervention
|
Duration the infant is in contact with the target is used to quantify changes in reaching.
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1 month post intervention
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Early Problem Solving Indicator (EPSI)
Time Frame: End of intervention, 1 and 3 months post intervention
|
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.
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End of intervention, 1 and 3 months post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Feeding Skill Assessment (FES)
Time Frame: Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
|
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.
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Baseline, End phase 1, End of intervention, 1 and 3 months post intervention
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Parent Child Early Relational Assessment (PCERA)
Time Frame: Baseline, End phase 1, End of intervention, 1 month post intervention
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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).
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Baseline, End phase 1, End of intervention, 1 month post intervention
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Bayley Scales of Infant and Toddler Development (Bayley).
Time Frame: 3 month post intervention
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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.
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3 month post intervention
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Test of Infant Motor Performance (TIMP)
Time Frame: Baseline to End of intervention
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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.
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Baseline to End of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stacey C Dusing, PhD PT, Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
May 27, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Actual)
January 29, 2018
Last Update Submitted That Met QC Criteria
January 3, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20001308
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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