Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders

Harbourne, Regina T.; Dusing, Stacey C.; Lobo, Michele A.; Westcott-McCoy, Sarah; Bovaird, James A.; Sheridan, Susan M.; Galloway, James C.; Chang, Hui-Wen; Hsu, Lin Ya; Koziol, Natalie A.; Marcinowski, Emily C.; Babik, Iryna

doi:10.1093/ptj/pzy033

Cited by 30 publications

(42 citation statements)

References 48 publications

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“…This clinical trial will add to a small, but growing, body of literature on early interventions for infants and toddlers with CP or suspected CP [ 63 , 64 ]. While the study design of a flexible treatment duration (12, 18, or 24 weeks) introduces statistical complexity, it will allow a standard analysis at the primary 12-week endpoint as well as valuable dose-response information, which will inform the design of future work.…”

Section: Discussionmentioning

confidence: 99%

iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial

et al. 2018

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BackgroundCerebral palsy (CP) is the most common cause of physical disability in children. The best opportunity to maximize lifelong independence is early in motor development when there is the most potential for neuroplastic change, but how best to optimize motor ability during this narrow window remains unknown. We have systematically developed and pilot-tested a novel intervention that incorporates overlapping principles of neurorehabilitation and infant motor learning in a context that promotes upright mobility skill and postural control development. The treatment, called iMOVE therapy, was designed to allow young children with CP to self-initiate motor learning experiences similar to their typically developing peers. This manuscript describes the protocol for a subsequent clinical trial to test the efficacy of iMOVE therapy compared to conventional therapy on gross motor development and other secondary outcomes in young children with CP.MethodsThe study is a single-blind randomized controlled trial. Forty-two participants with CP or suspected CP between the ages of 1–3 years will be randomized to receive either the iMOVE or conventional therapy group. Distinguishing characteristics of each group are detailed. Repeated measures of gross motor function will be collected throughout the 12–24 week intervention phase and at three follow-up points over one year post therapy. Secondary outcomes include measures of postural control, physical activity, participation and caregiver satisfaction.DiscussionThis clinical trial will add to a small, but growing, body of literature on early interventions to optimize the development of motor control in young children with CP. The information learned will inform clinical practice of early treatment strategies and may contribute to improving the trajectory of motor development and reducing lifelong physical disability in individuals with CP.Trial registrationClinicalTrials.gov identifier NCT02340026. Registered January 16, 2015.Electronic supplementary materialThe online version of this article (10.1186/s12887-018-1303-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial

et al. 2018

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“…Based on the theory of change supporting the START-Play intervention and detailed analysis of sample videos of intervention sessions representing START-Play and uEI, key components were identified and operationally defined (Table S1, online supporting information). 11,14 The key components were intended to examine the extent to which therapists deliver the intervention (six START-Play behaviors) and avoid activities being excluded from the intervention (five non-START-Play behaviors). These 11 behaviors formed the basis of the fidelity measure to measure accuracy of delivery of the START-Play intervention and differentiate START-Play from uEI.…”

Section: Methods Phase I: Development and Reliability Of The Fidelity mentioning

confidence: 99%

“…[6][7][8][9][10] The Sitting Together and Reaching to Play (START-Play) intervention aims to advance motor and cognitive skills in infants with neuromotor disorders. 11,12 A consortium of pediatric physical therapists, psychologists, education researchers, and interventionists developed the START-Play intervention based on effectiveness research and child development theories supporting grounded cognition. 12 The START-Play intervention emphasizes the importance of developing early motor skills (sitting and reaching) alongside the progression of problem-solving abilities, thus advancing learning and overall development (see Appendix S1, online supporting information, for comparison of START-Play and usual early intervention [uEI]).…”

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confidence: 99%

“…A fidelity measure for the START-Play intervention was developed as part of a randomized controlled trial comparing infants who received uEI services (uEI group) to infants who received the START-Play intervention in addition to uEI (START-Play group). 11 UEIs are federally funded services received by infants participating in the START-Play randomized controlled trial and may vary in type and amount. UEI was not defined or explained other than in the context of our measure, with early intervention provided to children because of motor delays, specifically delays in sitting and reaching.…”

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confidence: 99%

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Developing a fidelity measure of early intervention programs for children with neuromotor disorders

Nord

Koziol

et al. 2020

Develop Med Child Neuro

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Aim To describe the development of an intervention‐specific fidelity measure and its utilization and to determine whether the newly developed Sitting Together and Reaching to Play (START‐Play) intervention was implemented as intended. Also, to quantify differences between START‐Play and usual early intervention (uEI) services. Method A fidelity measure for the START‐Play intervention was developed for children with neuromotor disorders by: (1) identifying key intervention components, (2) establishing a measurement coding system, and (3) testing the reliability of instrument scores. After establishing acceptable interrater reliability, 103 intervention videos from the START‐Play randomized controlled trial were coded and compared between the START‐Play and uEI groups to measure five dimensions of START‐Play fidelity, including adherence, dosage, quality of intervention, participant responsiveness, and program differentiation. Results Fifteen fidelity variables out of 17 had good to excellent interrater reliability evidence with intraclass correlation coefficients (ICCs) ranging from 0.77 to 0.95. The START‐Play therapists met the criteria for acceptable fidelity of the intervention (rates of START‐Play key component use ≥0.8; quality ratings ≥3 [on a scale of 1–4]). The START‐Play and uEI groups differed significantly in rates of START‐Play key component use and quality ratings. Interpretation The START‐Play fidelity measure successfully quantified key components of the START‐Play intervention, serving to differentiate START‐Play from uEI.

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“…Later in the learning process, interventions aimed at advancing infants’ active performance of goal-oriented behaviors may help facilitate learning of means-end problem-solving concepts in infants at risk (Gibson, 1988; Lobo & Galloway, 2008, 2013; Lobo, Galloway, & Savelsbergh, 2004; O’Connor & Russel, 2015; Sommerville et al, 2008). Future studies should aim to develop and test the effectiveness of interventions that aim to positively impact infants’ means-end problem solving and learning (Harbourne et al, in press).…”

Section: Discussionmentioning

confidence: 99%

Prematurity may negatively impact means-end problem solving across the first two years of life

Cunha

Babik

Ross

et al. 2018

Research in Developmental Disabilities

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Preterm infants are at risk for delays in motor, perceptual, and cognitive development. While research has shown preterm infants may exhibit learning delays in the first months of life, these delays are commonly under-diagnosed. The purpose of this study was to longitudinally evaluate behavioral performance and learning in two means-end problem-solving tasks for 30 infants born preterm (PT) and 23 born full-term (FT). Infants were assessed at 6, 9, 12, 18, and 24 months-old in tasks that required towel pulling or turntable rotation to obtain a distant object. PT infants performed more non-goal-directed and less goal-directed behavior than FT infants throughout the study, resulting in a lower success rate among PT infants. PT infants showed delayed emergence of intentionality (prevalence of goal-directed behaviors) compared to FT infants in both tasks. Amount and variability of behavioral performance significantly correlated with task success differentially across age. The learning differences documented between PT and FT infants suggest means-end problem-solving tasks may be useful for the early detection of learning delays. The identification of behaviors associated with learning and success across age may be used to guide interventions aimed at advancing early learning for infants at risk.

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Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders

Abstract: This study describes usual care in EI across 4 US regions and compares outcomes of the START-Play intervention to usual care.

Cited by 30 publications

References 48 publications

iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial

iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial

Developing a fidelity measure of early intervention programs for children with neuromotor disorders

Prematurity may negatively impact means-end problem solving across the first two years of life

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