ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    dusing
Previous Study | Return to List | Next Study

Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention (TimeSPEEDI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03518736
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Preterm Infant Cerebral Palsy Behavioral: Supporting Play Exploration and Developmental Intervention (SPEEDI) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Timing Matter? Efficacy of Parent Provided, Therapist Supported, Motor and Cognitive Intervention for Infants Born Very Preterm in the First Months of Life
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arm Intervention/treatment
No Intervention: Usual Care
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
Experimental: SPEEDI_Early

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting in the hospital and lasting for 4 months. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention.

In addition they will continue with any intervention in the community recommended by their health care team.

Behavioral: Supporting Play Exploration and Developmental Intervention (SPEEDI)
Physical Therapy intervention

Experimental: SPEEDI_Late

Infants randomly assigned to this arm will participate in the SPEEDI intervention starting at 4 months post baseline or approximately 3 months after discharge from the hospital. This intervention includes 10 visits with a physical therapist and parent working together to advance an intervention program and 12 weeks of parent daily intervention.

In addition they will continue with any intervention in the community recommended by their health care team.

Behavioral: Supporting Play Exploration and Developmental Intervention (SPEEDI)
Physical Therapy intervention




Primary Outcome Measures :
  1. Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores [ Time Frame: 6 months ]
    Scales scores for the cognitive and gross motor scales each have a mean of 10 and a standard deviation of 10. Higher scores are better.


Secondary Outcome Measures :
  1. Early Problem Solving Indicator [ Time Frame: 6 months ]
    This play based assessment of early problem solving skills quantifies the frequency of 4

  2. Gross Motor Function Measure (GMFM) [ Time Frame: 6 months ]
    This is a measure of motor abilities that is sensitive to change for children with motor impairments. The GMFM-item set version will be used along with the Gross Motor Ability Estimator software to calculate a score on the GMFM-66.

  3. Test of Infant Motor Performance (TIMP) [ Time Frame: 3 months ]
    This is measure of motor abilities and selective motor control in infants less than 4 months of adjusted age or past their due date. The raw will be used to show change over time.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518736


Contacts
Contact: Stacey Dusing, PT, PhD 804-628-3632 scdusing@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
University of Virginia
Investigators
Principal Investigator: Stacey Dusing, PT, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03518736     History of Changes
Other Study ID Numbers: HM20013026
FP00007043 ( Other Identifier: Virginia Commonwealth University )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Cerebral Palsy
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases