Clinical trial NCT02593825: Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Official title: Efficacy of the START-Play Program for Infants With Neuromotor Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Developmental Delay
Infant Development
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: University of Delaware
name: Virginia Commonwealth University
name: University of Washington
name: University of Nebraska Lincoln
First posted: 2015-11-01
Enrollment: 134
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bayley Scales of Infant Development III
timeFrame: Baseline, at end of 3 month intervention, and at 12 months post-baseline
Secondary outcomes:
measure: Change in Modified Parent Child Interaction-Dyadic Mini Code
timeFrame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
measure: Change in Frequency (Number) of Toy Contacts
timeFrame: Baseline, at end of 3 month intervention, and at 12 months after baseline
measure: Change in Duration (Time) of Toy Contacts
timeFrame: Baseline, at end of 3 month intervention, and at 12 months after baseline
measure: Change in Gross Motor Function Measure, Sitting Subscale
timeFrame: Baseline, at end of 3 month intervention, and at 12 months after baseline
measure: Change in Early Problem Solving Indicator (EPSI)
timeFrame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline
measure: Change in Reaching (Change in Looking and Hand Contact of Toy)
timeFrame: Baseline, at end of 3 month intervention, and at 12 months after baseline
Other outcomes:
measure: Change in Postural Measure of Trunk Angle
timeFrame: Change over 3 months
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Regina T Harbourne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Sarah W McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Michele A. Lobo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Stacey C. Dusing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harbourne RT, Dusing SC, Lobo MA, Westcott-McCoy S, Bovaird J, Sheridan S, Galloway JC, Chang HJ, Hsu LY, Koziol N, Marcinowski EC, Babik I. Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders. Phys Ther. 2018 Jun 1;98(6):494-502. doi: 10.1093/ptj/pzy033.
citation: Koziol NA, Butera CD, Kretch KS, Harbourne RT, Lobo MA, McCoy SW, Hsu LY, Willett SL, Kane AE, Bovaird JA, Dusing SC. Effect of the START-Play Physical Therapy Intervention on Cognitive Skills Depends on Caregiver-Provided Learning Opportunities. Phys Occup Ther Pediatr. 2022;42(5):510-525. doi: 10.1080/01942638.2022.2054301. Epub 2022 Mar 29.
citation: Harbourne RT, Dusing SC, Lobo MA, McCoy SW, Koziol NA, Hsu LY, Willett S, Marcinowski EC, Babik I, Cunha AB, An M, Chang HJ, Bovaird JA, Sheridan SM. START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial. Phys Ther. 2021 Feb 4;101(2):pzaa232. doi: 10.1093/ptj/pzaa232.
citation: Marcinowski EC, Tripathi T, Hsu LY, Westcott McCoy S, Dusing SC. Sitting skill and the emergence of arms-free sitting affects the frequency of object looking and exploration. Dev Psychobiol. 2019 Nov;61(7):1035-1047. doi: 10.1002/dev.21854. Epub 2019 Apr 22.