WWC review of this study

START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants with Neuromotor Disorders: A Multisite Randomized Clinical Trial

Harbourne, Regina T., Dusing, Stacey C, Lobo, Michele A., McCoy, Sarah W., Koziol, Natalie A., Hsu, Lin-Ya, Willett, Sandra, Marcinowski, Emily C., Babik, Iryna, Cunha, Andrea B., An, Mihee, Chang, Hui-Ju, Bovaird, James A., Sheridan, Susan M. (2020). Physical Therapy Journal v101 p1-11. . Retrieved from: https://eric.ed.gov/?id=ED611838

  • Randomized Controlled Trial
     examining 
    112
     Students
    , grade
    PK

Reviewed: March 2022

At least one statistically significant positive finding
Meets WWC standards without reservations
Cognition outcomes—Indeterminate effects found
Outcome
measure
Comparison Period Sample Intervention
mean
Comparison
mean
Significant? Improvement
    index
Evidence
tier

Bayley Scales of Infant and Toddler Development, Third Edition: Cognition Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

35.94

33.61

No

--
More Outcomes

Assessment of Problem Solving in Play (APSP)

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

64.54

59.22

No

--
Show Supplemental Findings

Bayley Scales of Infant and Toddler Development, Third Edition: Cognition Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

Yes

 
 
17

Assessment of Problem Solving in Play (APSP)

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

Yes

 
 
16

Assessment of Problem Solving in Play (APSP)

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Full sample;
112 students

90.72

81.95

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Cognition Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Assessment of Problem Solving in Play (APSP)

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Cognition Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Assessment of Problem Solving in Play (APSP)

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

Yes

-19
 
 
Expressive Communication outcomes—Indeterminate effects found
Outcome
measure
Comparison Period Sample Intervention
mean
Comparison
mean
Significant? Improvement
    index
Evidence
tier

Bayley Scales of Infant and Toddler Development, Third Edition: Expressive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

12.52

11.59

No

--
More Outcomes
Show Supplemental Findings

Bayley Scales of Infant and Toddler Development, Third Edition: Expressive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Expressive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Expressive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

No

--
Functional Skills outcomes—Indeterminate effects found
Outcome
measure
Comparison Period Sample Intervention
mean
Comparison
mean
Significant? Improvement
    index
Evidence
tier

Gross Motor Function Measure (GMFM): Sitting dimension

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

34.96

31.35

No

--
More Outcomes

Bayley Scales of Infant and Toddler Development, Third Edition: Fine motor

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

25.00

23.45

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Gross Motor Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

31.65

30.10

No

--

Researcher-developed reaching assessment

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

13.14

13.05

No

--
Show Supplemental Findings

Gross Motor Function Measure (GMFM): Sitting dimension

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Fine motor

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

Yes

 
 
11

Bayley Scales of Infant and Toddler Development, Third Edition: Gross Motor Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

No

--

Researcher-developed reaching assessment

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Full sample;
112 students

16.46

15.03

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Fine motor

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Gross Motor Function Measure (GMFM): Sitting dimension

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Gross Motor Function Measure (GMFM): Sitting dimension

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Full sample;
112 students

47.13

44.88

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Fine motor

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Gross Motor Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Gross Motor Function Measure (GMFM): Sitting dimension

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Researcher-developed reaching assessment

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Gross Motor Scale

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--
Receptive Communication outcomes—Indeterminate effects found
Outcome
measure
Comparison Period Sample Intervention
mean
Comparison
mean
Significant? Improvement
    index
Evidence
tier

Bayley Scales of Infant and Toddler Development, Third Edition: Receptive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Full sample;
112 students

12.78

11.47

No

--
More Outcomes
Show Supplemental Findings

Bayley Scales of Infant and Toddler Development, Third Edition: Receptive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Mild motor delay at baseline;
62 students

N/A

N/A

Yes

 
 
15

Bayley Scales of Infant and Toddler Development, Third Edition: Receptive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

9 Months

Mild motor delay at baseline;
62 students

N/A

N/A

No

--

Bayley Scales of Infant and Toddler Development, Third Edition: Receptive communication

Sitting Together And Reaching To Play (START-Play) vs. Business as usual

0 Days

Significant motor delay at baseline;
50 students

N/A

N/A

No

--


Evidence Tier rating based solely on this study. This intervention may achieve a higher tier when combined with the full body of evidence.

Characteristics of study sample as reported by study author.


  • Female: 43%
    Male: 57%

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    Delaware, Nebraska, Pennsylvania, Virginia, Washington
  • Race
    Black
    10%
    Other or unknown
    20%
    White
    70%
  • Ethnicity
    Hispanic    
    18%
    Not Hispanic or Latino    
    82%

Setting

The study took place in five clinical sites across the United States. The clinical sites were located in Seattle, WA; Omaha, NE; Pittsburgh, PA; Newark, DE; and Richmond, VA.

Study sample

A total of 112 infants aged 7-16 months with motor delays were included in the study (57 in the intervention group and 55 in the comparison group). Infants were eligible for participation if they had difficulty transitioning in and out of sitting; had gross motor delays, defined as a gross motor score 1 standard deviation below the mean on the gross motor subtest of the Bayley Scales of Infant and Toddler Development, Third Edition; had a neuromotor disorder such as cerebral palsy; had an increased risk for cerebral palsy due to prematurity or brain damage around birth; or had a motor delay of an unknown origin. Study participants also had to be able to sit propped up on their arms for at least 3 seconds and make spontaneous movement of their arms. Infants were excluded from participating if they had medical complications that limited their participation in assessments and the intervention; a primary diagnosis of autism, Down syndrome, or spinal cord injury; a diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Approximately 43% of participants were female. About 70% were White, 10% were Black, and 20% were another race. Eighteen percent were Hispanic or Latino.

Intervention Group

Sitting Together and Reaching to Play (START-Play) is a set of practices designed to improve early motor skills and problem-solving skills among young infants with motor delays. The practices are intended to engage infants in physical activities that also incorporate problem solving skills, such as finding a hidden toy, reaching a toy that is out of reach, and exploring the properties and uses of objects. The START-Play intervention was provided by a trained, licensed physical therapist in conjunction with at least one parent or caregiver for 3 months (up to 24 visits). The intervention was performed with one infant at a time in a setting chosen by the caregiver at the start of the study, such as the home, daycare setting, or an assessment site. The average session length was 51.5 minutes, with a range between 40.8 to 60 minutes. Infants received START-Play in addition to their usual care and early intervention services.

Comparison Group

Infants in the comparison group received business-as-usual intervention services as mandated by law in the United States through the Individuals with Disability Education Improvement Act. Services provided by the infant's usual interventionist may have included early intervention and outpatient therapy for infants with developmental delays.

Support for implementation

The study authors trained the physical therapists who provided the intervention during individual sessions over three days. The physical therapists then viewed follow-up intervention videos until the therapist reached adequate levels of implementation fidelity. The training included a review of theoretical evidence supporting the intervention, in-person, hands-on training with infants, critique and feedback on treatment sessions, and refresher training.

 

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