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

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.

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

CONSORT Flow chart. This flow chart showing the recruitment and retention of participants in each arm of the clinical trial

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

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

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