Efficacy of the START-Play Program for Infants With Neuromotor Disorders (START-Play)

• ClinicalTrials.gov Identifier: NCT02593825
• Recruitment Status: Active, not recruiting
• First Posted: November 1, 2015
• Results First Posted: September 1, 2020
• Last Update Posted: September 1, 2020
• Sponsor: Duquesne University
• Collaborators: University of Delaware; Virginia Commonwealth University; University of Washington; University of Nebraska Lincoln
• Information provided by (Responsible Party): Duquesne University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy; Developmental Delay; Infant Development	Behavioral: START-Play intervention; Behavioral: Business as usual	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of the START-Play Program for Infants With Neuromotor Disorders
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: START-Play intervention; Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.	Behavioral: START-Play intervention; The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.; Other Name: Perceptual motor early intervention for infants
Active Comparator: Business as Usual; Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.	Behavioral: Business as usual; May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training; Other Name: Early intervention, physical therapy

Outcome Measures

Primary Outcome Measures :

1. Bayley Scales of Infant Development III [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months post-baseline ]
   Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome

Secondary Outcome Measures :

1. Change in Modified Parent Child Interaction-Dyadic Mini Code [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
   Play and interaction of parent and child, coding of behavior frequency and type of interaction
2. Change in Postural Measure of Trunk Angles [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
   kinematic measure of pelvic and trunk sagittal angle in sitting
3. Change in Frequency (Number) of Toy Contacts [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
   behavioral coding of play and hand use, coded from videotape; Coding software used to time contacts during standard reaching task during 5 minute reaching at shoulder level and below.
4. Change in Duration (Time) of Toy Contacts [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
   coding number seconds of videotaped hand use during play; timing coded in a video coding software for behavioral analysis Higher score=better
5. Change in Gross Motor Function Measure, Sitting Subscale [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
   Gross motor skills in the sitting subsection of the Gross Motor Function Measure (GMFM) Minimum value=4 Maximum value=60 Higher scores=better outcome
6. Change in Early Problem Solving Indicator (EPSI) [ Time Frame: Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline ]
   Infant growth and development indicator of problem solving skills, adapted for children with motor deficits Modified to Assessment of Problem-Solving in Play (APSP) Minimum=30 Maximum=120 Higher=better outcome
7. Change in Reaching (Change in Duration and Hand of Toy Contacts) [ Time Frame: Baseline, at end of 3 month intervention, and at 12 months after baseline ]
   Time of toy contacts, whether reach is one or two handed, higher number is better outcome, will indicate bilateral or unilateral

Eligibility Criteria

• Ages Eligible for Study: 7 Months to 16 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Pennsylvania

Duquesne University

Pittsburgh, Pennsylvania, United States, 15282

Sponsors and Collaborators

Duquesne University

University of Delaware

Virginia Commonwealth University

University of Washington

University of Nebraska Lincoln

Investigators

• Principal Investigator: Regina T Harbourne, PhD; Duquesne University
• Principal Investigator: Sarah W McCoy, PhD; University of Washington
• Principal Investigator: Michele A. Lobo, PhD; University of Delaware
• Principal Investigator: Stacey C. Dusing, PhD; Virginia Commonwealth University

  Study Documents (Full-Text)

Documents provided by Duquesne University:

Study Protocol  [PDF] July 17, 2015

Statistical Analysis Plan  [PDF] July 17, 2015

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duquesne University
• ClinicalTrials.gov Identifier: NCT02593825
• Other Study ID Numbers: R324A150103
• First Posted: November 1, 2015
• Results First Posted: September 1, 2020
• Last Update Posted: September 1, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Cerebral Palsy; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases