Efficacy of the START-Play Program for Infants With Neuromotor Disorders

Setting: The research will take place in the homes of infants and their families in
Pennsylvania, Delaware, Washington, and Virginia.

Sample: There will be approximately 140 infants with neuromotor disorders completing
participation in this study, beginning at the age the age of 7 to 16 months, as well as their
families and interventionists. Infants will have gross motor delays but be able to sit
propped up for at least 3 seconds when they are recruited for participation.

Intervention: Sitting Together And Reaching To Play (START-Play) is an intervention for
infants with motor dysfunction or delay in which physical therapists visit the child's home
to target work on siting, reaching, and problem solving. The therapist visits the home twice
weekly for 3 months. During these visits, therapists and families work together to provide
intensive, individualized, daily activities to advance reaching and sitting through small
increments of challenge and support for these skills, which then become the building blocks
for motor-based problem solving. More specifically, the intervention focuses on
self-initiated, goal-directed movements to build orientation and attention to objects, while
learning basic relationships of cause and effect. Infants and families in the intervention
group will receive this intervention in addition to their usual early intervention services.

Research Design and Methods: This study will use a randomized controlled trial in which
infants and their families are randomly assigned to the intervention group (START-Play in
addition to usual services) or control group (usual early intervention services), stratified
by severity of neuromotor disorder. There will be six measurement sessions during the 12-week
intervention period, following by assessments during 1-, 3-, and 9-month follow-up visits.
The study aims to determine the efficacy of the intervention on sitting and reaching
(proximal outcomes) and motor-based problem solving skills (longer-term proximal outcome),
which is hypothesized to serve as mediators to the more distal outcomes of global cognitive
development and readiness to learn. The investigators will also explore fidelity of
implementation to identify conditions that support fidelity and outcomes, as well as identify
other moderating factors related to the child (severity of disorder, health, age, cognitive
skill at entry), family (socioeconomic status, home environment), or services (fidelity of
implementation, other services provided to child) to explore change over time.

Control Condition: Infants and their families in the control condition will continue to
receive their regular Part C early intervention services.

Key Measures: Primary outcome measures in the study include the Gross Motor Function Measure
and an observational measure of toy contacts for sitting and reaching, and the Individual and
Growth Development Indicators (Early Problem Solving Indicator) and Bayley Scales of Infant
and Toddler Development -Third Edition for problem solving and global development. Secondary
measures include additional measures of postural control and reaching, child and family
characteristics, and fidelity of implementation (logs and checklist).

Data Analytic Strategy: The investigators will use linear mixed modeling (LMM) to determine
the efficacy of the intervention on child outcomes. Parallel process growth modeling within a
structural equation modeling framework will be used to examine whether improvements in
sitting and reaching are mediators leading to improvements in problem solving, which is then
a mediator leading to long-term global cognitive development. LMM will also be used to
examine moderating variables, as well as secondary motor outcomes.

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 at least to the level of neutral alignment with their
trunk.

- Gross motor delay as reflected in the Bayley III motor subtest >1.0 Standard
Deviation 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) -• Minimal movement requirements/Indicators of readiness for change: Sits
with support of arms for 3 seconds after being placed. Exhibits at least some
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).

- 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 that might affect
physical performance.