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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: SPEEDI Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>This group of subjects will receive usual care provided in the medial system and community. | |
| Experimental: SPEEDI Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, End phase 1, End of intervention, 1 and 3 months post intervention | 
| 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). | Baseline, End phase 1, End of intervention, 1 month post intervention | 
| 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. | 3 month post intervention | 
| 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. | Baseline to End of intervention |