CRITICALLY APPRAISED PAPER (CAP) Blanche, E. I., Chang, M. C., Gutiérrez, J., & Gunter, J. S. (2016). Effectiveness of a sensory-enriched early intervention group program for children with developmental disabilities. American Journal of Occupational Therapy, 70, 700522001. https://doi.org/10.5014/ajot.2016.018481 CLINICAL BOTTOM LINE Through the implementation of Part C of the federal Individuals With Disabilities Education Improvement Act of 2004, children with developmental delays receive early intervention (EI) services. Professionals working in EI settings have identified various challenges, such as choosing appropriate intervention models to accommodate complexities in developmental trajectories resulting from the diversity among families and children s diagnoses. Models tend to address either biological and environmental risks or specific diagnoses. Interdisciplinary Sensory-Enriched Early Intervention (ISEEI) is based on the use of sensory strategies, including an enriched environment, and is guided by sensory integration theory. An occupational therapist, a physical therapist, and a speech language pathologist designed ISEEI to be used by teachers and aides. In using this intervention, teachers and aides work in direct consultation with therapists. This study addresses the impact of the ISEEI program on children in an EI setting with developmental delays and sensory-processing difficulties. The results of this Level II retrospective cohort study of 63 children suggest that the ISEEI program delivered in a group setting is effective in reducing developmental delays in motor, language, and cognitive areas for children with developmental delays. Also, ISEEI was particularly effective for children with sensory-processing difficulties. The results show a significant overall improvement after 3 9 months of participation in the ISEEI program. The crucial elements of EI include Identifying children with developmental delays and giving them interventions early on, and Understanding sensory processing and its effect on development. Systematic assessment of sensory processing and development is necessary in the implementation of an EI program. Systematizing interventions helps develop evidence for the effectiveness of occupational therapy, and using sensory-enriched environments in EI can produce change in the developmental curve. RESEARCH OBJECTIVE(S) 1
To evaluate the effectiveness of the ISEEI group program for children with developmental delays To examine the manualized, interdisciplinary impact of the EI group program on development, as measured by a standardized developmental assessment To determine the effects of ISEEI on children with sensory-processing difficulties DESIGN TYPE AND LEVEL OF EVIDENCE Level II, retrospective chart review, cohort design PARTICIPANT SELECTION How were participants recruited and selected to participate? The researchers used a sample of convenience consisting of individuals from the ISEEI program. Such individuals participated in the ISEEI program between 2008 and 2010. The investigators did not include specifics regarding the location of the program or selection procedures. The most frequent reasons for referral were speech delays and social issues, overall developmental delays, genetic and neuromotor disorders, and diagnosis of autism spectrum disorder (ASD). Inclusion criteria: Children included in the study were 18 36 months old. The children had diagnoses and developmental delays in motor, cognition, or language areas or a combination of these areas. The participants represented a variety of conditions and were from diverse ethnic backgrounds. Exclusion criteria: Additional children who attended the program but did not meet inclusion criteria were excluded. Specific exclusion criteria were absent from the study. PARTICIPANT CHARACTERISTICS N= 63 #/ % Male: 41/65% #/ % Female: 22/35% Ethnicity: The ethnicities of the participants included White, Hispanic, African American, Asian, and Persian. The study did not specify percentages of each of these ethnicities. 2
Disease/disability diagnosis: All the children in this study had been diagnosed with developmental disabilities in motor, cognition, or language areas or a combination of these areas. The disorders varied from general developmental to neurological and genetic disorders. The study also indicated that some of the children (8%) who participated, were diagnosed with ASD. INTERVENTION AND CONTROL GROUPS Group 1: Participants with sensory-processing difficulties Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The intervention selected for this study was the ISEEI approach, which was implemented two to three times per week for 3 hours a day. The approach included 30 45 minutes per day in a sensory-enriched gym. There were 12 children in each group, with a 1:3 ratio of adults to children. The approach also included monthly in-home consultations; community activities, such as visits to parks and other recreational facilities; and parent training courses that focused on themes related to their child s development. 44 participants The intervention took place in the child s home, community, EI program classroom, and sensory-enriched gym. The therapist and the teachers and aides, in direct consultation with the therapists, delivered the intervention. The ISEEI intervention activities occurred two to three times per week. Each session was about 3 hours long. About 30 45 minutes per day were spent in a sensory-enriched gym. In addition to the intervention provided in the setting, the team offered monthly home consultations, community activities, and parent training courses. The program was for 3 9 months, but length varied among participants. Group 2: Participants without sensory-processing difficulties Brief description of the intervention The interventions for both groups were the same, except that the second group consisted of children without a diagnosis of sensory-processing difficulties. Both groups participated in the ISEEI program, which was carried out two to three times per week for 3 hours a day. The sessions included 30 45 minutes per day in a sensory-enriched gym. There were 12 children in each group, with a 1:3 ratio of adults to children. The approach also included monthly in-home consultations; community activities, such as visits to parks and other recreational facilities; and parent training courses that focused on themes related to their child s development. 3
How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 19 participants The intervention took place in the child s home, community, EI program classroom, and sensory-enriched gym. The therapist and the teachers and aides, in direct consultation with the therapists, delivered the intervention. The ISEEI intervention activities occurred two to three times per week. Each session was about 3 hours long. About 30 45 minutes per day were spent in a sensory-enriched gym. In addition to the intervention provided in the setting, the team offered monthly home consultations, community activities, and parent training courses. The program was for 3 9, months length but varied among participants. INTERVENTION BIASES Contamination: NR Co-intervention: NR Timing of intervention: The participants of this study received 3 9 months of ISEEI. Therefore, before reassessment occurred, some children were enrolled for longer periods of time than others. Site of intervention: NO All children received the intervention approach in the same setting. Use of different therapists to provide intervention: 4
NR Because the study took place over a 2-year time period (2008 2010), the therapists involved in the implementation of the intervention might have changed. Baseline equality: There was not an established control group for this study. Pretest results assisted the authors in identifying whether the child had sensory-processing difficulties. Findings then led the investigators to form the two groups. MEASURES AND OUTCOMES (Only measures relevant to occupational therapy practice) Measure 1: Bayley Scales of Infant and Toddler Development III (Bayley III) Name/type of measure used: The Bayley III is a performance measure and parent questionnaire. What outcome is measured? Performance of children 1 42 months old in the areas of cognition, receptive language, expressive language, and fine-motor and grossmotor skills Parent questionnaire measures social emotional and adaptive behaviors Is the measure reliable as reported in the article? Is the measure valid as reported in the article? When is the measure used? Not Reported Not Reported At the beginning of ISEEI enrollment and after 3 9 months of program participation MEASUREMENT BIASES Were the evaluators blind to treatment status? NO The investigators did not blind the trained raters. Furthermore, the raters were not necessarily the same for the pre- and posttests. Was there recall or memory bias? 5
The assessments were done with young children and their families. The Bayley III parent questionnaire was used as a pre- and postintervention assessment and therefore was given to the parents twice. As a result, there might have been parent recall or memory bias regarding the parent questionnaire aspect of the Bayley III. Other measurement biases: The Bayley III includes a component of parent responses. Bias might have been introduced through the parents response to the assessment questions. RESULTS List key findings based on study objectives: On the Bayley III, results showed significant overall improvements in all performance areas, including cognition (p <.001), language (both receptive and expressive; p <.001), fine-motor skills (p =.03), and gross-motor skills (p <.001). Of the parents of 63 children, 12 completed the socioemotional and adaptive behaviors questionnaires. On the basis of limited data returned by the parents, no significance was found. Results show that although there was no significant difference in Bayley III scale scores at enrollment between children with and without sensory-processing difficulties, there was a difference between both groups after the ISEEI. The group with sensory-processing difficulties exhibited significant improvements in cognition, gross-motor skills, and expressive and receptive language, whereas the group without sensory-processing difficulties exhibited significant improvements only in cognition and in expressive and receptive language. This indicates that the ISEEI had better results on motor performance for children with sensory-processing difficulties. The ISEEI program in a group setting was effective in reducing developmental delays in motor, language, and cognitive areas among children with developmental delays. Was this study adequately powered (large enough to show a difference)? NO Of the parents of 63 children, 12 parents completed the socioemotional and adaptive behaviors questionnaires for the Bayley III. Were the analysis methods appropriate? The authors used descriptive statistics and paired t tests with Bonferroni adjustments to analyze the scores of the Bayley III. Were statistics appropriately reported (in written or table format)? 6
The authors included written statistical analysis and tables to show results of the study. Was participant dropout less than 20% in total sample and balanced between groups? YES NO NR No participants dropped out of the study. What are the overall study limitations? Various biases limit the findings of this study. Sample bias included the use of a sample of convenience of 63 participants and the absence of a control group. Intervention bias included the fact that different therapists were involved in providing the treatment and assessment. Rater bias included the fact that the therapists, who were also trained raters, were not blinded. Raters were not necessarily the same for pre- and posttests, and they might have provided the intervention. Timing bias with assessment included reevaluations that took place after children participated in the program for 3 9 months. A systematic reevaluation of children should occur within a specific time frame, such as every 3 months. Reporter bias included the use of the Bayley III, which is an observational questionnaire given to parents and is based on their self-report. Measurement bias included the fact that only one measure was used in the postassessment. The authors did not reassess the Bayley III to identify changes in sensory processing of children in the program. Social emotional development and participation were not assessed in this study, and an observational measure of sensory processing was not administered. This was a retrospective study that looked back at results of the intervention program. 7
CONCLUSIONS The ISEEI program delivered in a group setting was effective in reducing delays in motor, language, and cognitive areas for children with developmental delays. It was particularly effective for children with sensory-processing difficulties. The ISEEI program follows many of the recommendations for children with ASD by the National Academy of Sciences and National Research Council. These include parental training, an intensive program of at least 25 hours per week, interventions composed of brief time intervals, a low student-to-adult ratio, and an ongoing assessment of children s progress. The program s effectiveness suggests that EI programs should follow these recommendations. The results indicate that the use of sensory-based interventions in the form of a sensory-enriched program can be effective for children with developmental delays and sensory-processing difficulties. The study also shows that children s developmental trajectory can be altered if they receive EI, which, in turn, can save resources in later life. Overall, the study supports previous studies that focused on EI for children with ASD and developmental disabilities. It also adds credibility to the contributions that can be made by occupational therapists. Further research is needed to determine the impact of the ISEEI program on social emotional skills, adaptive development, participation, and an observational measure of sensory processing. Future studies need to include a group of control participants who participate in programs that do not include a sensory-rich environment based on sensory integration theories. This work is based on the evidence-based literature review completed by Samantha Fulton, Bhumika Patel, and Varleisha Gibbs, PhD, OTD, OTR/L, Wesley College. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 8