In the United States, 1 in 8 infants are born prematurely (<37 weeks' gestation). Infants born premature are at increased risk for learning difficulties, lower quality of life, and motor disability, with up to 50% requiring special education.1,2 Although survival of infants born preterm is more certain than ever, federally mandated early intervention (EI) provided under the Individuals With Disabilities Education Improvement Act typically uses a wait-and-see approach; monitoring infants who are at risk and not providing EI services until a delay is detected. Some high-risk infants do not begin receiving services until months after discharge from the hospital.3 In addition, a large portion of infants born preterm who have developmental delays at 4 to 8 months4 or 2 years of age5 are not referred to or receiving EI services. Parents report, however, an interest in learning about infant development and a need for information on how to support development during the transition from the neonatal intensive care unit (NICU) to home.6–8
Infants and families who overcome the barriers to enrolling in EI services frequently receive low-intensity intervention, which evidence suggests has little to no lasting effect on motor and cognitive development.3,9 Basic science and clinical evidence, however, suggest early and intense intervention is more effective than a long-term low-intensity approach at promoting neural recovery in adults and children with a variety of disabilities.10,11 Although some studies have challenged current practice patterns, families of infants born preterm are not routinely provided with information or recommendations on why and how to provide early experiences in the first months of life.6,7,12–14 Delaying intervention limits the amount of intervention provided during a critical window for altering neural pathways and likely reduces the efficacy of EI on motor development.3,10,15
Supporting Play Exploration and Early Development Intervention (SPEEDI) is an intervention that blends the need for early and intense intervention with family support to engage families in their child's development during transition from the NICU to home and the community. Although theoretically grounded, the researchers were acutely aware of the challenges of engaging parents in developmental interventions during a stressful time for the family.8 Therefore, the purpose of this study was to evaluate the feasibility of SPEEDI and the feasibility of conducting a randomized controlled trial to evaluate the efficacy of SPEEDI. We hypothesized that parents would enroll in the study, infants randomized to the intervention group would complete more than 80% of the intervention described in the protocol, and parents of infants in the intervention group would report enjoying participation in the intervention. The secondary purpose was to determine the effect size of SPEEDI for the primary outcome measures.
Ten infants born at or before 34 weeks' postmenstrual age (PMA) were recruited from an urban, level III, NICU in an academic medical center. Family members provided informed consent for all infants before their participation. The university's Institutional Review Board approved the study. Infants were excluded from the study if they had a genetic syndrome or musculoskeletal deformity. To be included, infants were required to be medically stable, off ventilator support, demonstrate thermoregulation by 35 weeks' PMA, and live within 30 minutes of the hospital. After the first study assessment at 35 weeks' PMA, infants were randomly assigned to the intervention group or the usual care group. For multiple births, 1 infant was randomly selected to participate.
All infants enrolled in the study participated in the same assessment schedule, regardless of group assignment. A physical therapist (PT) blinded to group assignment conducted all assessments. To assess the feasibility of completing a clinical trial of SPEEDI, we tracked enrollment and outcome assessment completion statistics.
At the time of the baseline assessment, the Neonatal Medical Index (NMI) was used to categorize infants on the basis of their medical course.16
For infants in the SPEEDI group, we tracked the frequency of therapist intervention during phase 1, parent education sessions during phase 1, and parent delivered intervention during phase 2 using an activity log. These values were compared with the anticipated number of sessions on the basis of the study intervention methods.
On the last intervention visit for phase 2, the interventionist conducted a guided interview using principles of phenomenology to obtain feedback on the intervention from the parent who participated in SPEEDI.17 The interventionist asked the parents to share their feedback to help us make changes to the intervention for future studies. Open-ended guiding questions (Table 1) were used to promote discussion about the intervention. The interventionist asked the parent follow-up questions to expand on their comments as needed to ensure capturing the parent's feedback.
To consider of the effect of community service on the outcomes, at each visit the parent completed a questionnaire designed for this study to document whether the baby was receiving any EI services or outpatient therapy services.
The Test of Infant Motor Performance (TIMP) is a standardized instrument for assessing neuromotor development in infants between 34 weeks' PMA and 4 months' adjusted age (AA).18 The TIMP includes 13 observational and 28 elicited items and is a sensitive measure of motor performance that can be used to differentiate between high and low risk for poor infant motor outcomes.19 Test-retest reliability is 0.82, with intraclass correlation coefficients ranging from 0.95 to 0.99 for inter- and intrarater reliability.18 A PT that was trained and reliable administered the TIMP at baseline, 0, 3, and 4 months' AA.
The Bayley Scales of Infant and Toddler Development, 3rd Edition20 (Bayley) is a reliable norm-reference test designed to assess multiple developmental domains including cognition and motor abilities in infants 3 to 42 months of age.20 A PT that was trained and reliable administered the Bayley at 6 months' AA.
To identify subtle, but meaningful, changes in motor development, prereaching and reaching behaviors were assessed while the infant was sitting in an infant seat. Infants were observed performing in 4 conditions: a no-toy control condition (4 trials), exploration trials with a wrist rattle placed on either or both wrists (3 trials), reaching trials with an object in midline at chest height at approximately 75% of arm length (2 trials), and holding trials with a toy placed in the infant's hand (4 trials). Each trial lasted 30 seconds. Two synchronized video cameras were placed 4 ft to the front/right and front/left of the infant for a clear view of the infant's head, arms, and presented objects. Coders used MacSHAPA v1.1.2a behavioral coding software (Department of Mechanical and Industrial Engineering, University of Illinois at Urbana-Champaign, Urbana, IL) to quantify the duration of hand to midline for all conditions and the duration of toy contacts for reaching and holding conditions. The hand to midline behavior was selected as a representative prereaching behavior likely to increase before the infant's ability to make contact with the toy. Coders were blind to group assignment and study purpose. Coding reliability was assessed on 20% of the visits, with an agreement of 80.2% for hands to midline and 91.8% for hand contact.13
The Early Problem Solving Indicator (EPSI), the cognitive portion of the Individual Growth and Development Indicators (IGDI),21 was used to assess play-based problem solving during infant-directed play. The IGDI developers certified the EPSI coder as a reliable coder for the EPSI with greater than 85% agreement with master coders.
Infants enrolled in both the SPEEDI and the usual care group received standard care in the NICU and community. Both groups received a few infant toys as incentives and a small cash incentive to offset travel, parking, and time meeting with the study staff. Infants randomized to the SPEEDI group began intervention after the baseline assessment at 35 weeks' PMA. SPEEDI included 2 intervention phases: phase 1 in the NICU from 35 weeks' PMA to 0 months' AA (or hospital discharge) and phase 2 from 0 months' AA (or hospital discharge) until 3 months' AA.
Phase 1 was modeled after previous research, which provided infants in the NICU with daily movement experiences supported by a PT.22 Supporting Play Exploration and Early Development Intervention phase 1 included therapist-delivered intervention in the NICU provided 5 times per week for 20 minutes per session. The purpose of this intervention was to provide opportunities for the infant to experience variable and self-directed movements and social interaction. The therapist provided varying degrees of positioning and interaction support to encourage the infant's self-directed movements to bring the extremities and head toward midline and focus on toys or a face. The therapist completed a checklist after each visit, documenting which principles were addressed, which strategies were implemented, and which behaviors were observed.
The therapist met with the parent at least twice during phase 1 to discuss topics including the importance of promoting development, goals of the intervention, and to demonstrate each intervention activity. Before NICU discharge, parents in the intervention group received an activity booklet describing activities for working with their infant at home. The booklet was written at an 8th grade educational level and had pictures demonstrating the activities, which were also reviewed with the parent. The PT demonstrated or coached parents on how to complete the activities with their own infant or a doll if their own infant was too sleepy at the time of the last phase 1 visit. Infants received a minimum of 10 study visits with the PT including 2 parent education visits during phase 1. If an infant was discharged home before meeting this minimum requirement, daily home visits were arranged to meet this minimum required frequency.
During phase 2 of SPEEDI, the focus of the parent-delivered intervention was twofold. The first goal was to help the parent and infant establish a routine for developmentally appropriate play. This included the parent identifying the infant's cues of readiness to socially interact, monitoring the infant's response to interactions, and setting up routines such as playing after diaper changes. The second goal was to encourage the parent to provide opportunities and support the infant's self-directed movements to control posture, coordinate extremity movements, and interact with objects. This included activities such as holding the infant while gently encouraging bringing hands to midline, kicking, prone play, and placing wrist rattles or small toys in the infant's hands to encourage exploration. Parents were encouraged to complete intervention for a minimum of 5 times per week for 20 minutes per day. Parents completed a daily activity log, documenting if they worked on each activity. The therapist met with the parent and infant every 2 weeks until 3 months' AA to answer questions, progress intervention activities, and encourage parents to continue to complete the diary daily. A priori it was determined that infants who received less than 70% of the prescribed intervention would be dropped from the outcomes analysis given the preliminary nature of this study.
Descriptive statistics were used to describe the subjects and the feasibility measures including the percentage of participants who consented, completed the study, and completed phase 1 and phase 2 intervention. Interviews were transcribed verbatim and steps described by Moustakas for identifying pertinent comments, setting aside preconceived notions, identifying themes from each interview, and the essence from all interviews were completed by the first author, who did not conduct the interviews.17
Descriptive statistics were used to describe the community services and outcome measures at each data point for the intervention and usual care group. Cohen's d effect sizes were calculated comparing the outcomes at 3 months' AA, which was the end of the intervention. Effect sizes were interpreted as a small being less than 0.20, medium 0.5, and large greater than or equal to 0.80.23
Seventy-two percent of eligible infants consented to participate in the study and completed the baseline testing, resulting in a sample of 10 infants, 5 in each group (Table 2). Although not statistically different, the infants in the SPEEDI group had younger gestational ages, lower birth weights, and higher NMI ratings, which were considered clinically significant and suggested they were at a higher risk for developmental disabilities (Table 2). One infant in each group was lost to follow-up between NICU discharge and the 3-month AA assessment. One infant in the intervention group missed the 3-month AA assessment visit because of a family emergency, but this infant was retained in the study as the 4- and 6-month AA assessment visits were completed as scheduled.
All 5 infants in the intervention group completed phase 1 of the intervention. Infants who were randomized to the SPEEDI group received an average of 96.4% of the anticipated phase 1 visits, with a range of 74% to 115%. One infant was discharged home before meeting the minimum required phase 1 visits, resulting in 4 visits being completed in the infant's home. Five expected phase 1 intervention visits were missed because the infants were having or recovering from medical procedures or complications. The mean length of the intervention sessions was 21 (range: 16-25) minutes. All infants had at least 1 day in which the intervention session was ended early because the PT determined the infant was too sleepy, fatigued quickly, or physiologically unstable. Both intervention therapists were trained and experienced NICU PTs who were very sensitive to the needs of this population. They began and ended sessions on the basis of the infants' cues. Parents were present for a mean of 6.9 (range: 5-9) educational sessions with their infant during phase 1, although only 2 were required.
Four infants completed phase 2 of the intervention. One infant was in the NICU for 19 days of the phase 2 intervention. The parents and therapist collaborated to ensure they received intervention 5 times per week as indicated in the protocol. As a group, the infants received an average of 100.3% of recommended intervention during phase 2. Seventy-five percent of the parents who completed phase 2 intervention documented providing intervention at least 5 times per week. One parent recorded only 68% of the required intervention, so that infant's data were excluded from all outcomes analysis.
Parents provided valuable feedback on the SPEEDI. The essence of the interviews suggested 3 primary findings (Table 3). Parents reported the intervention helped them learn to communicate with their infant. They reported having a better understanding of the value of play and in the importance of providing opportunities to learn through play every day. Lastly, parents reported some confusion on how to interact with their infant early in the intervention and a desire for more parent–therapist interactions during phase 1 to prepare them to complete the phase 2 activities at home.
Six of the enrolled infants, 4 of whom were in the intervention group, received speech or occupational therapy as part of routine NICU care. Four infants, 3 in the control group, did not receive therapy services in the NICU as part of routine care. Four infants, 2 in each group, had multiple medical appointments with specialists between NICU discharge and 6 months of age. Eight infants were referred to EI before discharge from the NICU because the infant met at least 1 of the state eligibility criteria for EI service. One of the referred infants was lost to follow-up. Only 2 of the remaining 7 infants referred to EI were receiving EI services at the 3-month AA assessment (1 infant from each group). By 6 months' AA, 2 in each group were receiving at least monitoring services by their local EI program. Two infants had started receiving direct therapy services at 6 months' AA, both of whom were in the SPEEDI group.
The mean and the standard deviation (SD) of each outcome measure are presented in Table 4. Effect sizes compared the groups at 3 months' AA on each of the outcome measures at the end of the intervention. At the end of the intervention period, the intervention group had a mean TIMP z-score of 0.75 (SD = 0.10; n = 2) and the usual care group had a mean TIMP z-score of −0.08 (SD = 0.74; n = 4). A Cohen's d of 1.29 suggests a large effect size for TIMP z-scores. The intervention group exhibited problem-solving behaviors during 182.43 seconds (SD = 30.51; n = 2), and the usual care group displayed problem-solving behaviors during 122.33 seconds (SD = 19.07; n = 4) (Figure 1). A Cohen's d of 2.67 suggests a large effect size. The intervention group had a mean duration of hands in midline of 158.08 seconds (SD = 111.98; n = 2), and the usual care group had a mean duration of hands in midline of 69.55 seconds (SD = 56.61; n = 4) (Figure 2). A Cohen's d of 1.19 suggests a large effect size for hands in midline. At the end of the intervention period, the infants in the usual care group contacted the toys for a longer duration than the infants in the intervention group, so no effect size was calculated as this was in the opposite direction anticipated. However, this seems to reverse at 4 and 6 months' AA (Figure 3).
Supporting Play Exploration and Early Development Intervention is a feasible intervention for infants born preterm that engages parents in supporting their infant's development during the transition from the NICU to home. Infants received more than the hypothesized 80% of study visits during both intervention phases. Parents reported appreciation for being in the intervention group and acknowledged having a better understanding of the importance of development and how to interact with their infants after participating.
Challenges faced during phase 1 included difficulty timing the therapist-provided intervention. Sometimes multiple attempts were needed for the therapist to identify a time to provide the intervention when the infant was alert and could participate. Given the medical fragility of infants in the NICU it is not surprising, but some infants missed visits because of medical procedures such as surgery or eye examinations. Also, several parents reported they would have benefitted from increased education sessions in the NICU to prepare them to complete the activities independently at home after discharge. These challenges demonstrate a potential need to increase the role of parents and nurses in identifying infant readiness for interaction and providing developmental play activities in the NICU at times when the infant is alert.
Parents reported the phase 2 interventions occasionally were difficult to implement; however, they understood the importance of the activities and found a way to work them into even busy days. Although 1 parent was not able to document completing the intervention 5 times per week, several parents who were juggling specialist medical appointments were able to complete the 20 minutes of daily intervention for 3 months with encouragement and support from the research team. Parents reported they would not have known about the potential benefits of play interactions or noticed many of the ways their infant communicated if they had not been part of the study. However, after 3 months of daily home activities, the intervention was part of their routine and they intended to keep doing activities with their infant. These findings support the feasibility of SPEEDI as an infant and family-friendly intervention during the transition from the NICU to the home and community, which may help parent establish developmentally supportive routines.
Infants in the SPEEDI group received more therapeutic intervention as part of routine care than those in the control group. Although this may have affected the outcomes of this study, given the higher NMI, lower birth weight, and gestational age of the infants who were randomly assigned to the SPEEDI group, this is not surprising. In future studies with a larger sample, randomization should balance the groups and limit the effect of usual care therapy services on the outcome measures.
Infants in this study received limited developmental or therapeutic services between NICU discharge and 3 to 6 months' AA, although 8 infants met our state's inclusion criteria for EI services. Only 2 infants completed the EI eligibility determination process by the end of the SPEEDI period at 3 months' AA. This suggests that SPEEDI could fill a gap between the NICU and initiation of EI services. The low number of infants receiving EI services during the SPEEDI also reduces the likelihood that changes in outcomes are related to EI services, rather than SPEEDI.
Although the purpose of this study was not to determine the efficacy of SPEEDI, the large effect sizes for the primary outcome measures of the TIMP, EPSI, and hands to midline provide preliminary support for SPEEDI and the use of these outcome measures in future studies. In addition, the trends in all the outcomes measures suggest that SPEEDI has the potential to influence development beyond the end of the intervention period. An efficacy clinical trial of SPEEDI is needed to determine whether this novel intervention does improve short- and long-term developmental outcomes for infants born preterm before clinical implementation is warranted. In addition to the outcomes included in this feasibility study, measures of parent–child interaction would be beneficial to determine whether changes in interaction are the “active ingredient” that supports infant development. Lastly, investigation of the efficacy of each phase of SPEEDI is required to determine whether both phase 1 and phase 2 of the intervention are needed to maximize efficacy.
This study has several limitations that prevent the result from being generalized to all infants born preterm. All the infants were recruited from 1 NICU where therapy services were part of usual care, so the medical and nursing staff was comfortable with the addition of SPEEDI provided by experienced NICU therapy researchers who were well known to the NICU staff. Supporting Play Exploration and Early Development Intervention was provided in addition to usual care, which may not be similar to usual care in other NICUs. Parents in both groups were provided with weekly financial stipends to cover the travel costs of coming to the NICU during phase 1. This may have increased parent visitation above what is typical in both groups. Two infants were lost to follow-up and 1 infant missed the end of the intervention visit at 3 months' AA. In addition, 1 infant did not complete the required intervention and was removed from the outcomes analysis on the basis of a priori criteria. Thus, the sample size of 4 infants in the control group and 2 in the intervention at 3 months of AA was too small for statistical comparisons. Although the parent interviews were conducted with guiding questions and transcribed, the interviews were conducted by the interventionist so parent may have been hesitant to share negative aspects of the intervention. In addition, a single researcher identified the themes and essence of the qualitative analysis, and the sample size was limited to the 4 parents in the intervention group who were still enrolled at the end of phase 2. These limitations will be considered the planning for future efficacy studies of SPEEDI.
Supporting Play Exploration and Early Development Intervention is a feasible intervention for infants born preterm to bridge a current gap in services between the NICU and the community. This feasibility study supports the need for ongoing assessment of the efficacy of SPEEDI and the use of the included outcome measures as well as measures of parent–child interaction in future studies.
We thank the parents and dedicated NICU nursing staff that assisted with this study. We also thank Laura Haley and Allison Turchan for their many hours of video management and behavioral coding for this study.
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developmental disabilities/prevention and control; developmental psychology; female; humans; infant; infant care; intensive care units; male; neonatal; newborn; parenting; parents/education; physical therapy/methods; play therapy; premature/growth and development; premature/psychology
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