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

NCT03518736 | Active Not Recruiting

• 2 other identifiers: HM20013026FP00007043
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Infant; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Assessment of Problem Solving in Play

  6 months

• Gross Motor Function Measure (GMFM)

  6 months

• Test of Infant Motor Performance (TIMP)

  3 months

Study Arms (3)

Usual Care

NO INTERVENTION

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.

SPEEDI_Early

EXPERIMENTAL

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)

SPEEDI_Late

EXPERIMENTAL

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)

Interventions

Supporting Play Exploration and Developmental Intervention (SPEEDI) BEHAVIORAL

Physical Therapy intervention

SPEEDI_Early; SPEEDI_Late

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 32329778 DERIVED

MeSH Terms

Conditions

Premature Birth; Cerebral Palsy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stacey Dusing, PT, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 8, 2018
• Study Start: February 6, 2019
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

US (2)