Study: 90301

Single Study Review

Review Details

Reviewed: March 2022

At least one statistically significant positive finding

Meets WWC standards without reservations

For:

Single Study Review (findings for Sitting Together And Reaching To Play (START-Play))

Using:

Research Design:

Randomized Controlled Trial

Rating:

Meets WWC standards without reservations because it is a randomized controlled trial with low attrition.

This review may not reflect the full body of research evidence for this intervention.

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

Findings

Cognition outcomes—Indeterminate effect found for the domain
Outcome measure	Comparison	Period	Sample	Intervention mean	Comparison mean	Significant?	Improvement index
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	--
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 effect found for the domain
Outcome measure	Comparison	Period	Sample	Intervention mean	Comparison mean	Significant?	Improvement index
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	--
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 effect found for the domain
Outcome measure	Comparison	Period	Sample	Intervention mean	Comparison mean	Significant?	Improvement index
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	--
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 effect found for the domain
Outcome measure	Comparison	Period	Sample	Intervention mean	Comparison mean	Significant?	Improvement index
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	--
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.

Sample Characteristics

Characteristics of study sample as reported by study author.

Female: 43%
Male: 57%
Urban
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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%

Study Details

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.

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