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

Primary Purpose

Preterm Infant, Cerebral Palsy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supporting Play Exploration and Developmental Intervention (SPEEDI)
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Infant

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Care

SPEEDI_Early

SPEEDI_Late

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores
Scales scores for the cognitive and gross motor scales each have a mean of 10 and a standard deviation of 3. Higher scores are better.

Secondary Outcome Measures

Assessment of Problem Solving in Play
This play based assessment of early problem solving skills quantifies the frequency of 5 behaviors
Gross Motor Function Measure (GMFM)
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.
Test of Infant Motor Performance (TIMP)
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.

Full Information

First Posted
April 25, 2018
Last Updated
April 5, 2023
Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03518736
Brief Title
Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention
Acronym
TimeSPEEDI2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH)

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
SPEEDI_Early
Arm Type
Experimental
Arm Description
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.
Arm Title
SPEEDI_Late
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supporting Play Exploration and Developmental Intervention (SPEEDI)
Intervention Description
Physical Therapy intervention
Primary Outcome Measure Information:
Title
Bayley Scaled of Infant and Toddler Development Cognitive and Gross Motor Scaled Scores
Description
Scales scores for the cognitive and gross motor scales each have a mean of 10 and a standard deviation of 3. Higher scores are better.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of Problem Solving in Play
Description
This play based assessment of early problem solving skills quantifies the frequency of 5 behaviors
Time Frame
6 months
Title
Gross Motor Function Measure (GMFM)
Description
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.
Time Frame
6 months
Title
Test of Infant Motor Performance (TIMP)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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. Infants must be medically stable, off ventilator support by 42 weeks of gestation 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Dusing, PT, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32329778
Citation
Dusing SC, Burnsed JC, Brown SE, Harper AD, Hendricks-Munoz KD, Stevenson RD, Thacker LR, Molinini RM. Efficacy of Supporting Play Exploration and Early Development Intervention in the First Months of Life for Infants Born Very Preterm: 3-Arm Randomized Clinical Trial Protocol. Phys Ther. 2020 Aug 12;100(8):1343-1352. doi: 10.1093/ptj/pzaa077.
Results Reference
derived

Learn more about this trial

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

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