Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Feb 9;18(1):46.
doi: 10.1186/s12887-018-1011-4.

Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial

Stacey C Dusing  1 , Tanya Tripathi  2 , Emily C Marcinowski  3 , Leroy R Thacker  4 , Lisa F Brown  5 , Karen D Hendricks-Muñoz  6
Affiliations
Randomized Controlled Trial

Supporting play exploration and early developmental intervention versus usual care to enhance development outcomes during the transition from the neonatal intensive care unit to home: a pilot randomized controlled trial

Stacey C Dusing et al. BMC Pediatr. .

Abstract

Background: While therapy services may start in the Neonatal Intensive Care Unit (NICU) there is often a gap in therapy after discharge. Supporting Play Exploration and Early Development Intervention (SPEEDI) supports parents, helping them build capacity to provide developmentally supportive opportunities starting in the NICU and continuing at home. The purpose of this single blinded randomized pilot clinical trial was to evaluate the initial efficacy of SPEEDI to improve early reaching and exploratory problem solving behaviors.

Methods: Fourteen infants born very preterm or with neonatal brain injury were randomly assigned to SPEEDI or Usual Care. The SPEEDI group participated in 5 collaborative parent, therapist, and infant interventions sessions in the NICU (Phase 1) and 5 at home (Phase 2). Parents provided daily opportunities designed to support the infants emerging motor control and exploratory behaviors. Primary outcome measures were assessed at the end of the intervention, 1 and 3 months after the intervention ended. Reaching was assessed with the infant supported in an infant chair using four 30 s trials. The Early Problem Solving Indicator was used to evaluate the frequency of behaviors during standardized play based assessment. Effect sizes are including for secondary outcomes including the Test of Infant Motor Performance and Bayley Scales of Infant and Toddler Development.

Results: No group differences were found in the duration of toy contact. There was a significant group effect on (F1,8 = 4.04, p = 0.08) early exploratory problem-solving behaviors with infants in the SPEEDI group demonstrating greater exploration with effect sizes of 1.3, 0.6, and 0.9 at the end of the intervention, 1 and 3 months post-intervention.

Conclusions: While further research is needed, this initial efficacy study showed promising results for the ability of SPEEDI to impact early problem solving behaviors at the end of intervention and at least 3 months after the intervention is over. While reaching did not show group differences, a ceiling effect may have contributed to this finding. This single blinded pilot RCT was registered prior to subject enrollment on 5/27/14 at ClinicalTrials.Gov with number NCT02153736.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Human Subjects Board at Virginia Commonwealth University and a parent signed permission for their own and their child’s participation as well as access to their child’s medical records throughout the study period.

Consent for publication

Not Applicable for the body of the manuscript as no individual level data or pictures are in the manuscript.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
CONSORT Flow chart. This flow chart showing the recruitment and retention of participants in each arm of the clinical trial
Fig. 2
Fig. 2
Problem Solving Outcomes. The frequency of problem solving behaviors during a 6-min interaction with 3 standardized toys. A: total problem solving behaviors. B: frequency of looks and explores, 2 specific types of problem solving behaviors. Star represented statistically significant group differences. Error bar represent 1 standard deviation from the mean. The effect size (d) for each comparison is included
Fig. 3
Fig. 3
Global Development Outcomes. The Bayley composite score 3 months post intervention and at 12 months of age, approximately 9 months post intervention are provided for the Cognitive, Language (expressive and receptive), and Motor (Gross and Fine) domains. The 9 month post intervention visits includes infants who attended the Neonatal Continuing Care Program clinic visit and had a completed Bayley. Two infant in the SPEEDI group and 1 in the usual care group did not attend the clinic visit. One infant in the usual care group attended the clinic but could not complete the Bayley due to significant motor impairments
Fig. 4
Fig. 4
Group Differences in Motor Development with Increasing Age. The individual scores on the TIMP and predicted regression lines from the post hoc MLM with a significant interaction term. Suggests the rate of development was impacted by changes in age and group assignment
See this image and copyright information in PMC

References

    1. McCormick MC, Litt JS, Smith VC, Zupancic JA. Prematurity: an overview and public health implications. Annu Rev Public Health. 2010;32:367–79. doi: 10.1146/annurev-publhealth-090810-182459. - DOI - PubMed
    1. Wocadlo C, Rieger I. Educational and therapeutic resource dependency at early school-age in children who were born very preterm. Early Hum Dev. 2006;82(1):29–37. doi: 10.1016/j.earlhumdev.2005.06.005. - DOI - PubMed
    1. Kuban KC, Allred EN, O'Shea TM, Paneth N, Pagano M, Dammann O, Leviton A, Du Plessis A, Westra SJ, Miller CR, et al. Cranial ultrasound lesions in the NICU predict cerebral palsy at age 2 years in children born at extremely low gestational age. J Child Neurol. 2009;24(1):63–72. doi: 10.1177/0883073808321048. - DOI - PMC - PubMed
    1. MacKay DF, Smith GC, Dobbie R, Pell JP. Gestational age at delivery and special educational need: retrospective cohort study of 407,503 schoolchildren. PLoS Med. 2010;7(6):e1000289. doi: 10.1371/journal.pmed.1000289. - DOI - PMC - PubMed
    1. Wong T, Taylor HG, Klein N, Espy KA, Anselmo MG, Minich N, Hack M. Kindergarten classroom functioning of extremely preterm/extremely low birth weight children. Early Hum Dev. 2014;90(12):907–914. doi: 10.1016/j.earlhumdev.2014.09.011. - DOI - PMC - PubMed

Publication types

Associated data