Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Phase: NA
Conditions: Cerebral Palsy, Developmental Delay, Infant Development
Sponsor: Duquesne University

 
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Protocol Summary form for Department of Education Grant 
Title: Efficacy of the START-Play Program for Infants with Neuromotor Disorders 
 
Investigator: Regina Harbourne 
1. Statement of the research question 
This large 4-year multi-site study aims to determine the efficacy of a specific program of 
intervention for infants with neuromotor disorders such as cerebral palsy. The project is funded 
by the National Center for Special Education Research within the US Dept. of Education, with 
Duquesne University as the lead site. The overall purpose of this project is to evaluate the 
efficacy of a fully developed intervention designed to target sitting, reaching and motor-based 
active problem solving in infancy to improve global developmental outcomes and readiness to 
learn prior to preschool for children with neuromotor dysfunction. The following are our primary 
and secondary hypotheses. 
PRIMARY HYPOTHESES 
Hypothesis 1: Compared to a control group receiving standard of care services, the START-Play 
group will show greater improvements from pre- to post- intervention (short-term effect) in:  
a. sitting Variable: Gross Motor Function Measure (GMFM) sitting scores 
b. reaching Variable: Number of toy contacts 
c. problem-solving Variable: Individual Growth and Development Indicator(IGDI) problem-
solving score 
d. global development Variable: Bayley III score 
Hypothesis 2: Compared to the control group, the START-Play group will show greater sustained 
improvements from pre-intervention to one year since start of intervention (long-term effect) in:  
a. sitting Variable: GMFM sitting scores 
b. reaching Variable: Number of toy contacts 
c. problem-solving Variable: IGDI problem-solving score 
d. global development Variable: Bayley III score 
Hypothesis 3 (Mediation): Improvements in global development will be (at least) partially 
mediated by improvements in problem-solving as a function of the intervention at the end of the 
project (long-term proximal effect).  
Variables: GMFM scores, toy contacts, IGDI problem-solving and Bayley III scores.  
SECONDARY HYPOTHESES 
Analysis of moderators  
1. Hypothesis: Severity of motor impairment will have a significant influence on overall change 
in IGDI problem-solving, and motor scores, as well as Bayley III scores. Variable: Severity score   
2. Hypothesis: Factors external to the child (socialization opportunities [Modified Parent Child 
Interaction-Dyadic Mini Code scores (Censullo, 1991) (PCI-DMC)], and home environment 
(HOME Inventory [Bradley, 1993] & SocioEconomic Status [SES]), will have a moderate effect 
on change in GMFM, problem-solving, and Bayley III scores. 
Further analysis of motor variables  
3. Hypothesis: The START-Play group will show posture control short-term postural control 
changes that are closer to normative values than the control group from pre to post intervention (3 
months post baseline). This hypothesis tests additional variables quantifying sitting to supplement 
Primary Hypothesis 1. Variables: Kinematic measures taken from video analysis. 
4. Hypothesis: Compared to the control group, the START-Play Intervention group will show 
greater short-term improvements in duration of toy contact and object manipulation from pre to 
post intervention (3 months post baseline). This hypothesis tests additional variables quantifying 
reaching to supplement the Primary Hypothesis 2. Variables:  Unilateral and bilateral contact 
number and duration, and type of contact (i.e. hand open or closed; palmar or dorsal hand surface, 
manipulation variables). 
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016

 
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2. Purpose and significance of the study 
Infants use two fundamental motor skills, sitting and reaching, for orientation and selection of 
important environmental information. Emerging during development at around 6 months of age, 
these motor skills form the core abilities to explore the environment and propel further learning 
and development (Soska et al, 2010; Rochat 1992; Adolph & Berger 2011). Not surprisingly, 
children with delays in these skills experience a cascade of motor, cognitive and social 
impairments. These impairments seriously impede readiness to learn at pre-school and 
subsequently school age (van der Heide et al, 2004; Ricken et al, 2005). For children with 
neuromotor dysfunction, we define “readiness to learn” as a level of development at which the 
child can orient and attend to information in the world, actively engage with materials and people, 
begin to solve problems, and perform developmentally appropriate tasks. 
 
Although early intervention services are well established throughout the United States, 
the evidence that these services make a difference in developmental or educational outcomes for 
infants with neuromotor dysfunction is limited (Spittle et al, 2007). Early intervention is a 
federally mandated system of services (Individuals with Disabilities Education Act, Part C, 2004) 
to advance developmental outcomes in infants and toddlers who have developmental delays or 
disabilities. Motor intervention for children with neuromotor disorders (e.g., cerebral palsy) 
consists of developmentally appropriate movement activities prescribed by a physical therapist, 
with the goal of advancing movement skills such as sitting, crawling, walking or moving with 
assistive devices (e.g., walker, wheelchair). A recent review of randomized trials of early 
intervention for preterm infants found that, although there were significant short-term advances in 
cognitive outcomes during infancy, motor skills were not affected by early intervention, and 
short-term effects on cognitive outcome were not sustained at school age (Orton et al, 2009). No 
studies have specifically examined infants with neuromotor dysfunction. In addition, early motor 
intervention historically has been passive, and has not been linked to learning (Rapport et al, 
2004; Dunst & Trivette, 2008).  Consequently, there is a knowledge gap about which specific 
interventions produce positive motor outcomes that are related to global development and 
problem solving. The START-Play intervention targets the primary skills of sitting and reaching 
at a critical point when infants need to learn these skills in order to advance understanding of the 
world. For most infants with neuromotor disorders sitting and reaching do not emerge on time, 
which begins a cycle of lost learning opportunities, ultimately resulting in the significant lack of 
readiness to learn often noted in preschool. Early in infancy, delays in sitting and reaching reduce 
the likelihood that an infant builds understanding of spatial concepts (Soska et al, 2010), social 
relationships (Palisano et al, 2009), problem-solving (Fennell & Dikel, 2001), and play skills 
(Brown & Gordon, 1987) that scaffold global development and result in educationally relevant 
outcomes. This proposal is the first comprehensive research plan to build these key skills early 
enough to enhance early learning capacity for children with neuromotor disorders. Thus, our 
overall purpose is to test the efficacy of a motor intervention for infants with neuromotor 
disorders compared to early intervention services provided as usual care. 
3. Research design and procedures 
The study design enrolls infants with neuromotor disorders or identified delays in a 3-month 
randomized controlled trial with a repeated measures design plus a nine-month follow-up. The 
design is longitudinal to best capture changes over time within both the control group and the 
START-Play group, and to distinguish advances in skill due to the specific intervention (START-
Play) vs. general development under the usual model. Recruitment of study participants will be 
continuous throughout the project’s first three years, and assignment to condition will occur at the 
individual child level. It will not be possible to have a control group without intervention because 
all recruited children will be delayed enough to have mandated early intervention services. The 
experimental group will receive the START-Play intervention as well as their regular early 
intervention services. Randomization is stratified by the severity of neuromotor disorder(mild, 
moderate, severe).After randomization to group via a computer-generated list, assessment begins. 
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016

 
3
The assessment schedule covers entry month (between 7-16 months of age) and the following 12 
months (between 19-28 months of age). Five assessments are done at Baseline, Mid-treatment, 
final post-trea1ment testing, 3 months follow up and final Follow-up (see Table 1). Infants are 
started in the study on a rolling basis, as they reach the appropriate age and skill level (see entry 
criteria). 
Table 1. Assessment Schedule 
 
After the baseline assessment, infants in the START-Play group will begin the 
intervention with therapists from the START-Play project trained specifically in the START-Play 
intervention, and the infants in the control group will continue with their regular services with 
their community service provider. All infants will receive the same assessments, as well as survey 
instruments to the families to determine the level of other services received by the infant. All 
infants will have regular intervention sessions videotaped at least once for quantification of 
procedures and to assure the fidelity of the intervention being provided across children.  
The control intervention is the usual Early Intervention services provided to infants and 
mandated by public law, which consists of general developmental education and advice and in 
some cases low frequency therapy. Infants randomized to the intervention group will receive 
home visits twice weekly for the START-Play physical therapy intervention for three months. 
The daily intervention will be provided by the caregiver, based on suggestions from the twice 
weekly visits of the START-Play therapist. The START-Play Intervention is designed to advance 
sitting and reaching, and secondarily improve exploration, manipulation and problem-solving 
skills. The START-Play therapy visits will be provided by either the primary investigator or by a 
consultant therapist (from Children’s Hospital trained and supervised by the PI. See appendix B 
in full proposal for examples of START-Play intervention activities. 
4. Instruments  
1) Primary Measures for Sitting and Reaching 
These variables quantify the initial functional delays in these skills and changes during the 
Intervention and Follow-up periods. Data will be collected using video by a START-Play 
assessment therapist and the post doctoral fellow on the START-Play grant (to be hired). Data 
reduction and coding will take place at various sites, with each site having a focus (Duquesne for 
kinematics, Delaware for reaching, VCU for problem solving, UW for Bayley and GMFM, UNL 
for fidelity and overall statistical analysis and data management. 
 
GMFM sitting section 
The Gross Motor Function Measure (GMFM, Russell et al 1993) is the international standard 
outcome assessment tool for quantifying change in the gross motor abilities of children with 
neuromotor disorders (inter-rater reliability, r=.97, Russell et al 2000).  
Data Collection: The test will be videotaped in the home setting. 
Data Analysis: Each sections raw score and % of the section completed will be coded. 
Assessment 
number 
1 
2 
3 
4 
5 
6 
Timetable 
(months after 
study entry) 
0 
1 
2 
3 
6 
12 
SittingVideo 
Reaching Video 
Baseline 
testing 
prior to 
intervention 
Rx 
 
 
 
Mid Rx 
testing  
Final post 
Rx testing 
sitting and 
reaching 
Follow-up Final Follow-
up 
Standardized 
Assessment 
 Bayley III, 
GMFM,  
IGDI 
GMFM,  
IGDI  
 Bayley III 
GMFM,  
IGDI 
Bayley 
III, 
GMFM, 
IGDI 
 Bayley III, 
GMFM,  
IGDI  
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016

 
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GMFM scoring form uploaded. 
 
Number of toy contacts 
Data Collection:  Infants are provided six 30 second trials to reach for an object sitting upright on 
the floor under 3 different levels of support for a total of 18 trials. One of three levels of support 
are used: at the waist, at the hips, or no support. Trials begin when infants are visually attending 
to the object. Infants are presented with a graspable toy in midline at chest height 75% of arm 
length. Two synchronized video cameras assure a clear view for behavioral coding. 
Data Analysis: Coders will determine number of toy contacts (and secondary variables, see 
section below) by coding the videos. Contact occurs when any hand surface contacts the object. 
Coders are blind to group assignment and study purpose. Coding reliability is assessed on 20% of 
the sessions and is based on a comparison of agreements and disagreements from each visit. 
Based on previous work, coders will maintain inter- and intra-rater reliability >90%. 
2) Primary Measure for Problem-Solving 
 
Individual Growth and Development Indicators (IGDIs)  
 
The Infant and Toddler IGDIs are brief psychometrically sound measurements of young 
children’s abilities (Carta et al, 2002) across 4 outcome areas. We have found the Early Problem 
Solving Indicator (Greenwood et al, 2006) (EPSI) to be sensitive and suitable for assessing infants 
when assessors are well-trained (>90% agreement). It defines problem solving as consisting of 
visual exploration, object manipulation and memory. Previous studies show good reliability 
(r=.93) and validity, and its usefulness in documenting change over time.  
Data collection: To test, the child is videoed for 6 minutes when presented with standard toys.  
Data analysis: Key skill elements are coded for frequency from video. Frequencies are summed, 
weighted as to complexity of the behavior, and divided by time for a total rate. We will use the 
certification process online to insure that IGDI testers and coders attain a satisfactory level 
(90%)of reliability. Members of this consortium piloted the problem solving IGDI on children 
with neuromotor disorders, creating standardized adaptations for children with limited movement.  
3) Primary Measure for Global Development 
 
Bayley Scales of Infant and Toddler Development–Third Edition (Bayley III, Bayley, 2006),  
The Bayley III is a well known norm-referenced test designed to assess five key 
developmental domains: cognition, language, social-emotional, motor and adaptive behavior. 
Videotapes of this test will be scored to reach reliability of 90% agreement at the UW site. 
4) Secondary Measures: These variables quantify factors related to the primary measures above.  
Secondary Measures for Sitting related to impairments in postural control: 
 
Trunk alignment as an infant develops sitting posture has long been used as a clinical 
measure of postural control (McGraw, 1943; Bly, 1983; Harbourne et al, 1993). Movement and 
posture in sitting will be sampled monthly and quantified with kinematic measures from video.  
 
Instrumentation:  Quantification of sitting posture data will occur via a video taken from 
the side view of the infant (Harbourne et al, 1993).  Data will provide:  
 
angle of forward bending during independent sitting,   
 
angular velocity and displacement from vertical to self-supported resting position  
These variables are indicators of the control the infant is developing for maintaining upright 
sitting. Standardized positioning of child and camera will allow accurate use of the SIMI Move 
application to quantify the trunk control in sitting (90%agreement)(Surkar et al, 2013). 
Data Collection and Analysis:  The infant will be placed in a sitting position on the floor, and 
supported by the examiner; the examiner then removes their hands, which have been supporting 
the trunk. Measurement is taken from the point of the initial supported position to the end 
position independently assumed by the infant, and is quantified by degrees.  Data are collected for 
3 trials while the child attempts to maintain sitting. See Appendix A. 
Secondary Measures for Reaching (documents impairments in reaching and object exploration): 
These variables are coded from video to further quantified reaching: 
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016

 
5
 
Age of reach onset and number infants that are reaching at each age.  An infant is ‘reaching’ 
the first session he contacts the toy more than 5 times in 3 min of trial time (Lobo et al 2004). 
 
Percent of time each hand is in contact with the toy (aka Contact Duration). 
 
Number of toy contacts with both hands 
 
Hand position at initial contact and during contact: open/closed hand, ventral/dorsal surface. 
Secondary Measures: Child and Family Characteristics 
 
Child characteristics (Severity, Cognitive, Age, Health) will be recorded, respectively, 
from a Severity Index, Bayley III scores, and a Demographic questionnaire and Health 
questionnaire, which are both completed by parents. Environmental factors include: 1) 
Parent/child interaction (PCI-DMC) See Figure 1, Appendix C., 2) Home environment (HOME 
scale [Elardo & Bradley, 1981]), 3) Socioeconomic status (SES), 4) program 
attendance/participation (visit counts), and 4) overall amount of services (Therapy Services 
questionnaire). The Home Observation for Measurement of the Environment (HOME) Inventory 
– Infant/Toddler version assesses the home environment including adult/child contact, 
social/cultural experiences, physical environment, and access to toys. SES will be measured on a 
Demographic questionnaire completed by parents. Program attendance will be recorded by the 
number of accomplished visits, documented by the therapist visiting the home. Amount of 
therapy recorded on the Therapy Service questionnaire completed by parents(Appendix C).  
 
Our fidelity approach will determine the degree to which all elements of the START-Play 
intervention are delivered across treatment and control conditions (Knoche et al, 2010). We will 
assess dosage, adherence, quality, participant responsiveness, and program differentiation (Berkel 
et al., 2011; Cordray & Pion, 2006; Dane & Schneider, 1998; O’Donnell, 2008) with three 
primary measures: (1) START-Play Home Visit Coding Guide (adapted from the Home Visit 
Observation Form; McBride & Peterson, 1997) (see Appendix C); (2) Therapy Services Form 
(adapted fromWestcott & Effgen, 2011; Appendix C); and (3) Home Activity Log (Appendix C). 
Both the experimental and control groups will be measured using these instruments.  
5. Sample selection and size 
Infants (n=42) with neuromotor disorders will be randomly assigned to either the 
experimental intervention (START-Play Intervention) or to a control group between 7-16 months 
of age depending on motor skill readiness for sitting and reaching activities. We expect a 10% 
drop-out rate in this longitudinal study, for a final number of 38 children at our site, 19 in each 
group. Power analysis was conducted for this multi-site trial on pilot data for each variable, and 
N=152 (4 sites, 38 each), with 93%-99% ability to detect true difference in our primary variable. 
Inclusion criteria: 
 
Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds 
and maintain their head to the level of neutral alignment with their trunk.  
 
Gross motor delay as scored on the Bayley III motor subtest >1.0 SD below the mean.  
 
Neuromotor disorder such as cerebral palsy (CP), or at risk for CP because of extreme 
prematurity or brain damage that occurred at or around birth, or infants with motor delay of 
an unspecified origin (no clear diagnosis, but delay as above) 
 
Eligible infants may meet the U.S. federal criteria for children with disabilities in one of the 
following categories:  orthopedic impairments, multiple disabilities, other health 
impairments, or developmental delay.  
 
Minimal movement requirements/Indicators of readiness for change: Sits with support of 
arms for 3 seconds after being placed. Exhibits  minimal spontaneous movement of arms.  
Exclusion criteria: 
 
Medical complications that severely limit participation in assessments and intervention such 
as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.    
 
Diagnosis other than an unchanging neuromotor disorder (examples: autism, Down 
syndrome, spinal cord injury, acquired head injury, muscle disorder). 
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016

 
6
A child will be excluded if the parents report any of following:  1) if the child has a disability of a 
progressive nature such as muscular dystrophy; 2) if the child’s family plans to move out of the 
local area within one year from the start of the study; 3) if the child has major surgery planned. 
6. Recruitment of subjects 
Infants will be recruited from Children’s Hospital of Pittsburgh centers and follow-up clinics, 
local Early Intervention (EI) programs, and local EI therapists. Flyers (attached) will be provided 
to these centers with contact information of the PI (Harbourne) for interested families. Any 
information provided to clinics or therapists will indicate that participation in the study is 
voluntary, and that families will be paid a small honoraria (total of $100) for participation in the 
multiple sessions, and infants will be provided small gifts.  
7. Informed consent procedures 
During the first contact made with the infant and family, written information explaining the 
study will be provided that explains in simple terms, a) criteria for participation, b) purpose of the 
research and procedures involved, c) the families right to withdraw the infant at any time without 
penalty of any kind, d) assurance of anonymity (via number representation vs. name). If the 
infants meets the inclusion criteria and not the exclusion criteria, and the family is interested, the 
information just described will be reviewed, questions will be answered and an informed consent 
will be signed in the presence of a designated research personnel and witness. Families will be 
reminded that this signature does not bind them to participate and that they are free to withdraw at 
any time without providing a reason. 
8. Collection of data and method of data analysis 
All infants (both groups) and their families will participate in assessments starting at 7-16 months 
of age and continuing for 12 months. The five assessment sessions are in addition to the 
intervention sessions, and will be done in the home. The control intervention is the usual Early 
Intervention services provided to infants and mandated by public law, which consists of general 
developmental education and advice and in some cases low frequency therapy. Infants 
randomized to the intervention group will receive home visits twice weekly for physical therapy 
intervention for three months. The START-Play Intervention is designed to advance sitting and 
reaching to improve problem-solving skills (see Appendix B for examples of intervention). Each 
participating site will analyze a specific part of the video or survey data: Bayley test & GMFM, 
UW; IGDI & PCI, VCU; Reaching variables, UD; Sitting variables, Duquesne University; 
Fidelity, factors external to the child, and statistical analysis, UNL. UNL will house all data and 
create/maintain a data sharing system whereby all sites can securely upload, download, store and 
share videos from all sites, using password protected access to the UNL server.  
9. Emphasize issues relating to interactions with subjects and subjects' rights. 
The START-Play Intervention is low risk. Specifically, this intervention consists of play activities 
that are developmentally appropriate for young infants and are supervised by family and therapist.  
Families and therapists work together to select the activities, and families are provided education 
on progressing their infants to more challenging and fun activities. The risk of participation is no 
greater than during typical floor activities between an infant and family. Risks are minimized by 
having families and investigators within arm’s reach and focused on the infant at all times. The 
infant is never left unattended. 
 
Assessments completed during home visits involve typical activities of infants such as 
sitting, rolling and reaching. The risk of participation is no greater than during typical floor 
activities between an infant and family. Videos obtained of these assessments will be sent to a 
central data management site (UNL) and made available to all the sites for scoring at each site on 
specific variables. These videos will not include identifying information, and will have a code and 
no names. The identifying information will only be available to the primary investigator at each 
site, and will be kept in a locked file. Families will be offered electronic copies of any video of 
their child that they want. 
Duquesne University IRB 
Protocol #2015-06-5 
Approved: 7-17-2015 
Expiration Date: 7-16-2016