Trial Outcomes & Findings for Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention (NCT NCT02153736)
NCT ID: NCT02153736
Last Updated: 2018-01-29
Results Overview
Duration the infant is in contact with the target is used to quantify changes in reaching.
COMPLETED
NA
14 participants
1 month post intervention
2018-01-29
Participant Flow
Participant milestones
| Measure |
Usual Care Group
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Usual Care Group
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Medical status change made ineligible
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Initial Efficacy Study of Supporting Play, Exploration, & Early Development Intervention
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=7 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=7 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 Weeks of post menstrual age
n=5 Participants
|
39 Weeks of post menstrual age
n=7 Participants
|
38 Weeks of post menstrual age
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Gestational age
|
26 weeks of gestation
n=5 Participants
|
25 weeks of gestation
n=7 Participants
|
25.5 weeks of gestation
n=5 Participants
|
|
Brain Injury (GIII/IV intraventricular hemorrhage , Periventricular leukomalacia, Hypoxic Ischemic E
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post interventionDuration the infant is in contact with the target is used to quantify changes in reaching.
Outcome measures
| Measure |
Usual Care Group
n=5 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=5 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Reaching (Toy Contact Duration)
|
20.2 Seconds
Standard Deviation 21.45
|
28.02 Seconds
Standard Deviation 16.30
|
PRIMARY outcome
Timeframe: End of intervention, 1 and 3 months post interventionPopulation: Same as primary population with the 2 infants lost to follow up not included.
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.
Outcome measures
| Measure |
Usual Care Group
n=5 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=5 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Early Problem Solving Indicator (EPSI)
End of intervention
|
58.00 # of Problem Solving Behaviors in 6 min
Standard Deviation 39.59
|
103.2 # of Problem Solving Behaviors in 6 min
Standard Deviation 28.89
|
|
Early Problem Solving Indicator (EPSI)
1 months post intervention
|
95.2 # of Problem Solving Behaviors in 6 min
Standard Deviation 52.95
|
131.80 # of Problem Solving Behaviors in 6 min
Standard Deviation 61.44
|
|
Early Problem Solving Indicator (EPSI)
3 months post intervention
|
146 # of Problem Solving Behaviors in 6 min
Standard Deviation 86.17
|
212 # of Problem Solving Behaviors in 6 min
Standard Deviation 54.98
|
SECONDARY outcome
Timeframe: Baseline, End phase 1, End of intervention, 1 and 3 months post interventionPopulation: Some infants were not able to orally feed in which case this measure was not included. In addition, some visits were missing feeding assessments for missing data. Thus the sample included varied some between visits.
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.
Outcome measures
| Measure |
Usual Care Group
n=6 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=6 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Early Feeding Skill Assessment (FES)
Baseline
|
8.32 EFS Total score
Standard Deviation .48
|
8.61 EFS Total score
Standard Deviation 1.44
|
|
Early Feeding Skill Assessment (FES)
End phase 1
|
8.27 EFS Total score
Standard Deviation 1.27
|
8.82 EFS Total score
Standard Deviation 1.58
|
|
Early Feeding Skill Assessment (FES)
End of intervention Phase 2
|
8.00 EFS Total score
Standard Deviation 0.44
|
9.65 EFS Total score
Standard Deviation 1.17
|
|
Early Feeding Skill Assessment (FES)
1 month post intervention
|
10.10 EFS Total score
Standard Deviation 1.36
|
9.91 EFS Total score
Standard Deviation 1.12
|
|
Early Feeding Skill Assessment (FES)
3 months post intervention
|
10.00 EFS Total score
Standard Deviation 1.42
|
10.40 EFS Total score
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline, End phase 1, End of intervention, 1 month post interventionPopulation: The sample varied some between visits do to a lack of video taping the parent child interaction on a few occasions because the parent who consented to the study was not present at the time of the visit and the visit could not be rescheduled. The 3 month post intervention visit was dropped.
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).
Outcome measures
| Measure |
Usual Care Group
n=6 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=6 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Parent Child Early Relational Assessment (PCERA)
Baseline
|
0.27 Mean Score on PCERA
Standard Deviation 0.17
|
0.13 Mean Score on PCERA
Standard Deviation 0.29
|
|
Parent Child Early Relational Assessment (PCERA)
End phase 1
|
0.20 Mean Score on PCERA
Standard Deviation 0.30
|
0.38 Mean Score on PCERA
Standard Deviation 0.33
|
|
Parent Child Early Relational Assessment (PCERA)
End of intervention Phase 2
|
0.34 Mean Score on PCERA
Standard Deviation 0.24
|
0.25 Mean Score on PCERA
Standard Deviation 0.23
|
|
Parent Child Early Relational Assessment (PCERA)
1 months post intervention
|
0.50 Mean Score on PCERA
Standard Deviation 0.51
|
0.26 Mean Score on PCERA
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 3 month post interventionPopulation: At 3 months post intervention the sample was consistent with that described in the study sample post lose to followup.
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.
Outcome measures
| Measure |
Usual Care Group
n=5 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=5 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Bayley Scales of Infant and Toddler Development (Bayley).
Motor 3 months post intervention
|
79.6 Mean Composite Score on Bayley
Standard Deviation 20.8
|
98.6 Mean Composite Score on Bayley
Standard Deviation 11.4
|
|
Bayley Scales of Infant and Toddler Development (Bayley).
Cognitive 3 months post intervention
|
80.0 Mean Composite Score on Bayley
Standard Deviation 13.5
|
91.0 Mean Composite Score on Bayley
Standard Deviation 8.9
|
|
Bayley Scales of Infant and Toddler Development (Bayley).
Language 3 months post intervention
|
89.0 Mean Composite Score on Bayley
Standard Deviation 19.6
|
98.2 Mean Composite Score on Bayley
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline to End of interventionPopulation: Full Sample after infants lost to follow up who are not included in this analysis.
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.
Outcome measures
| Measure |
Usual Care Group
n=5 Participants
This group of subjects will receive usual care provided in the medial system and community.
|
SPEEDI Intervention
n=5 Participants
This group will receive and parent and physical therapy provided intervention to increase the infants opportunities for play which will enhance development.
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.
|
|---|---|---|
|
Test of Infant Motor Performance (TIMP)
Baseline
|
54 Raw Score on the TIMP
Interval 37.0 to 60.0
|
61 Raw Score on the TIMP
Interval 56.0 to 63.0
|
|
Test of Infant Motor Performance (TIMP)
End of Intervention
|
82 Raw Score on the TIMP
Interval 72.0 to 95.0
|
99 Raw Score on the TIMP
Interval 97.0 to 118.0
|
Adverse Events
Usual Care Group
SPEEDI Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stacey Dusing, PT, PhD, PCS, Director Motor Development Lab
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place