Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention



Status:Recruiting
Conditions:Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:Any
Updated:2/13/2019
Start Date:February 6, 2019
End Date:July 30, 2023
Contact:Stacey Dusing, PT, PhD
Email:scdusing@vcu.edu
Phone:804-628-3632

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Does Timing Matter? Efficacy of Parent Provided, Therapist Supported, Motor and Cognitive Intervention for Infants Born Very Preterm in the First Months of Life

Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental
disabilities including cerebral palsy, coordination impairments, attention deficit and
learning disabilities. Impairment including reduced postural control, movement variability,
visual motor skills, and motor learning are common during the first months of life and are
associated with later developmental disabilities. However, infant born very preterm rarely
receive evidence based therapeutic intervention in the first months of life when basic
science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment
in services delay the onset of services and delivery models rarely support targeted
preventative intervention or enhanced parent engagement during in the transition from the
neonatal intensive care unit (NICU) to home.

Targeted intervention supporting postural control and motor learning in the NICU have
resulted in short term motor gains. Interventions that enhance parent's ability to read their
infant's cues and provide engagement opportunities improve maternal mental health and infant
social and cognitive outcomes in the short-term. The purpose of this randomized clinical
trial is to evaluate the efficacy of an intervention that combines evidence based motor
intervention and parent engagement to enhance the parent's ability to provide daily motor and
cognitive opportunities resulting in improved motor and cognitive outcomes.

Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation
to empower parents in reading infant's behavioral cues, identifying ideal times for
interaction, and enriching the environment and learning opportunities. Parents participate in
5 session in 3 weeks while learning principles of engagement, readiness for interaction, and
to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of
motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical
therapist support. The parent is empowered to determine the infant's current abilities and
advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely
continuing after the intervention.

The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from
the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the
infants due date). Ninety infants will be randomly assigned to a Usual Care group,
SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental
outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler
Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure
at the end of each intervention period, 12 and 24 months of age.


Inclusion Criteria:

- All infants born very preterm (˂29 weeks of gestation) and cared for in the Neonatal
Intensive Care Unit at the Children's Hospital of Richmond (CHoR) at Virginia
Commonwealth University (VCU) or University of Virginia Hospital (UVa) will be offered
an enrollment if they meet the following inclusion criteria.

1. Infants must be medically stable, off ventilator support by 42 weeks of gestation

2. live within 60 miles of either hospital (which are 75 miles apart). Early
Intervention services in Virginia.

- A parent or LRA will also be enrolled in the study. Inclusion criteria for the adult
is that they speak English and will be a caregiver for the enrolled infant.

Exclusion Criteria:

- Exclusion criteria include diagnosis of a genetic syndrome or unstable medical
condition beyond 42 weeks of gestation.
We found this trial at
1
site
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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