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Cluster randomized trial of the classroom SCERTS intervention for elementary students with autism spectrum disorder.

ABSTRACT: OBJECTIVE:This cluster randomized trial (CRT) evaluated the efficacy of the Classroom Social, Communication, Emotional Regulation, and Transactional Support (SCERTS) Intervention (CSI) compared with usual school-based education with autism training modules (ATM). METHOD:Sixty schools with 197 students with autism spectrum disorder (ASD) in 129 classrooms were randomly assigned to CSI or ATM. Mean student age was 6.79 years (SD 1.05) and 81.2% were male. CSI teachers were trained on the model and provided coaching throughout the school year to assist with implementation. A CRT, with students nested within general and special education classrooms nested within schools, was used to evaluate student outcomes. RESULTS:The CSI group showed significantly better outcomes than the ATM group on observed measures of classroom active engagement with respect to social interaction. The CSI group also had significantly better outcomes on measures of adaptive communication, social skills, and executive functioning with Cohen's d effect sizes ranging from 0.31 to 0.45. CONCLUSION:These findings support the preliminary efficacy of CSI, a classroom-based, teacher-implemented intervention for improving active engagement, adaptive communication, social skills, executive functioning, and problem behavior within a heterogeneous sample of students with ASD. This makes a significant contribution to the literature by demonstrating efficacy of a classroom-based teacher-implemented intervention with a heterogeneous group of students with ASD using both observed and reported measures. (PsycINFO Database Record

SUBMITTER: Morgan L

PROVIDER: S-EPMC6457665 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Cluster randomized trial of the classroom SCERTS intervention for elementary students with autism spectrum disorder.

Morgan Lindee L Hooker Jessica L JL Sparapani Nicole N Reinhardt Vanessa P VP Schatschneider Chris C Wetherby Amy M AM

Journal of consulting and clinical psychology 20180701 7

<h4>Objective</h4>This cluster randomized trial (CRT) evaluated the efficacy of the Classroom Social, Communication, Emotional Regulation, and Transactional Support (SCERTS) Intervention (CSI) compared with usual school-based education with autism training modules (ATM).<h4>Method</h4>Sixty schools with 197 students with autism spectrum disorder (ASD) in 129 classrooms were randomly assigned to CSI or ATM. Mean student age was 6.79 years (SD 1.05) and 81.2% were male. CSI teachers were trained o ...[more]

PMID: 29939056

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Project description:ImportanceUniversal early screening for autism spectrum disorder (ASD) is recommended but not routinely performed.ObjectiveTo determine whether computer-automated screening and clinical decision support can improve ASD screening rates in pediatric primary care practices.Design, setting, and participantsThis cluster randomized clinical trial, conducted between November 16, 2010, and November 21, 2012, compared ASD screening rates among a random sample of 274 children aged 18 to 24 months in urban pediatric clinics of an inner-city county hospital system with or without an ASD screening module built into an existing decision support software system. Statistical analyses were conducted from February 6, 2017, to June 1, 2018.InterventionsFour clinics were matched in pairs based on patient volume and race/ethnicity, then randomized within pairs. Decision support with the Child Health Improvement Through Computer Automation system (CHICA) was integrated with workflow and with the electronic health record in intervention clinics.Main outcomes and measuresThe main outcome was screening rates among children aged 18 to 24 months. Because the intervention was discontinued among children aged 18 months at the request of the participating clinics, only results for those aged 24 months were collected and analyzed. Rates of positive screening results, clinicians' response rates to screening results in the computer system, and new cases of ASD identified were also measured. Main results were controlled for race/ethnicity and intracluster correlation.ResultsTwo clinics were randomized to receive the intervention, and 2 served as controls. Records from 274 children (101 girls, 162 boys, and 11 missing information on sex; age range, 23-30 months) were reviewed (138 in the intervention clinics and 136 in the control clinics). Of 263 children, 242 (92.0%) were enrolled in Medicaid, 138 (52.5%) were African American, and 96 (36.5%) were Hispanic. Screening rates in the intervention clinics increased from 0% (95% CI, 0%-5.5%) at baseline to 68.4% (13 of 19) (95% CI, 43.4%-87.4%) in 6 months and to 100% (18 of 18) (95% CI, 81.5%-100%) in 24 months. Control clinics had no significant increase in screening rates (baseline, 7 of 64 children [10.9%]; 6-24 months after the intervention, 11 of 72 children [15.3%]; P = .46). Screening results were positive for 265 of 980 children (27.0%) screened by CHICA during the study period. Among the 265 patients with positive screening results, physicians indicated any response in CHICA in 151 (57.0%). Two children in the intervention group received a new diagnosis of ASD within the time frame of the study.Conclusions and relevanceThe findings suggest that computer automation, when integrated with clinical workflow and the electronic health record, increases screening of children for ASD, but follow-up by physicians is still flawed. Automation of the subsequent workup is still needed.Trial registrationClinicalTrials.gov identifier: NCT01612897.

Project description:Social and communication impairments are core deficits and prognostic indicators of autism. We evaluated the impact of supplementing a comprehensive intervention with a curriculum targeting socially synchronous behavior on social outcomes of toddlers with autism spectrum disorders (ASD).Fifty toddlers with ASD, ages 21 to 33 months, were randomized to one of two six-month interventions: Interpersonal Synchrony or Non-Interpersonal Synchrony. The interventions provided identical intensity (10 hours per week in classroom), student-to-teacher ratio, schedule, home-based parent training (1.5 hours per month), parent education (38 hours), and instructional strategies, except the Interpersonal Synchrony condition provided a supplementary curriculum targeting socially engaged imitation, joint attention, and affect sharing; measures of these were primary outcomes. Assessments were conducted pre-intervention, immediately post-intervention, and, to assess maintenance, at six-month follow-up. Random effects models were used to examine differences between groups over time. Secondary analyses examined gains in expressive language and nonverbal cognition, and time effects during the intervention and follow-up periods.A significant treatment effect was found for socially engaged imitation (p = .02), with more than doubling (17% to 42%) of imitated acts paired with eye contact in the Interpersonal Synchrony group after the intervention. This skill was generalized to unfamiliar contexts and maintained through follow-up. Similar gains were observed for initiation of joint attention and shared positive affect, but between-group differences did not reach statistical significance. A significant time effect was found for all outcomes (p < .001); greatest change occurred during the intervention period, particularly in the Interpersonal Synchrony group.This is the first ASD randomized trial involving toddlers to identify an active ingredient for enhancing socially engaged imitation. Adding social engagement targets to intervention improves short-term outcome at no additional cost to the intervention. The social, language, and cognitive gains in our participants provide evidence for plasticity of these developmental systems in toddlers with ASD. http://www.clinicaltrials.gov/ct2/show/NCT00106210?term = landa&rank = 3.

Project description:ImportanceAutism behavioral therapy is effective but expensive and difficult to access. While mobile technology-based therapy can alleviate wait-lists and scale for increasing demand, few clinical trials exist to support its use for autism spectrum disorder (ASD) care.ObjectiveTo evaluate the efficacy of Superpower Glass, an artificial intelligence-driven wearable behavioral intervention for improving social outcomes of children with ASD.Design, setting, and participantsA randomized clinical trial in which participants received the Superpower Glass intervention plus standard of care applied behavioral analysis therapy and control participants received only applied behavioral analysis therapy. Assessments were completed at the Stanford University Medical School, and enrolled participants used the Superpower Glass intervention in their homes. Children aged 6 to 12 years with a formal ASD diagnosis who were currently receiving applied behavioral analysis therapy were included. Families were recruited between June 2016 and December 2017. The first participant was enrolled on November 1, 2016, and the last appointment was completed on April 11, 2018. Data analysis was conducted between April and October 2018.InterventionsThe Superpower Glass intervention, deployed via Google Glass (worn by the child) and a smartphone app, promotes facial engagement and emotion recognition by detecting facial expressions and providing reinforcing social cues. Families were asked to conduct 20-minute sessions at home 4 times per week for 6 weeks.Main outcomes and measuresFour socialization measures were assessed using an intention-to-treat analysis with a Bonferroni test correction.ResultsOverall, 71 children (63 boys [89%]; mean [SD] age, 8.38 [2.46] years) diagnosed with ASD were enrolled (40 [56.3%] were randomized to treatment, and 31 (43.7%) were randomized to control). Children receiving the intervention showed significant improvements on the Vineland Adaptive Behaviors Scale socialization subscale compared with treatment as usual controls (mean [SD] treatment impact, 4.58 [1.62]; P = .005). Positive mean treatment effects were also found for the other 3 primary measures but not to a significance threshold of P = .0125.Conclusions and relevanceThe observed 4.58-point average gain on the Vineland Adaptive Behaviors Scale socialization subscale is comparable with gains observed with standard of care therapy. To our knowledge, this is the first randomized clinical trial to demonstrate efficacy of a wearable digital intervention to improve social behavior of children with ASD. The intervention reinforces facial engagement and emotion recognition, suggesting either or both could be a mechanism of action driving the observed improvement. This study underscores the potential of digital home therapy to augment the standard of care.Trial registrationClinicalTrials.gov identifier: NCT03569176.

Project description:IntroductionIndividuals with autism spectrum disorder (ASD) who also exhibit severe-to-moderate ranges of intellectual disability (ID) still face many challenges (i.e., less evidence-based trials, less inclusion in school with peers).MethodsWe implemented a novel model called the "Developmental and Sequenced One-to-One Educational Intervention" (DS1-EI) in 5- to 9-year-old children with co-occurring ASD and ID. The treatment protocol was adapted for school implementation by designing it using an educational agenda. The intervention was based on intensity, regular assessments, updating objectives, encouraging spontaneous communication, promoting skills through play with peers, supporting positive behaviors, providing supervision, capitalizing on teachers' unique skills, and providing developmental and sequenced learning. Developmental learning implies that the focus of training is what is close to the developmental expectations given a child's development in a specific domain. Sequenced learning means that the teacher changes the learning activities every 10-15 min to maintain the child's attention in the context of an anticipated time agenda. We selected 11 French institutions in which we implemented the model in small classrooms. Each institution recruited participants per dyads matched by age, sex, and developmental quotient. Patients from each dyad were then randomized to a DS1-EI group or a Treatment as usual (TAU) group for 36 months. The primary variables - the Childhood Autism Rating scale (CARS) and the psychoeducational profile (PEP-3) - will be blindly assessed by independent raters at the 18-month and 36-month follow-up.Discussion and baseline descriptionWe enrolled 75 participants: 38 were randomized to the DS1-EI and 37 to the TAU groups. At enrollment, we found no significant differences in participants' characteristics between groups. As expected, exposure to school was the only significant difference [9.4 (±4.1) h/week in the DS1-EI group vs. 3.4 (±4.5) h/week in the TAU group, Student's t-test, t = 5.83, p < 0.001].Ethics and disseminationThe protocol was authorized by the competent national regulatory authority (Agence nationale de sécurité du médicament et des produits de santé) and approved by the local Ethics Committee (Comité de Protection des Personnes) at the University Hospital Saint-Antoine (May 7, 2013). The findings will be disseminated through peer-reviewed journals and national and international conferences.Trial registration numbersANSM130282B-31 (April 16 2013) and ACTRN12616000592448 (May 6 2016).

Project description:The objective of this trial, Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART), was to provide support and guidance for an evidence-based approach for the selection and monitoring of initial pharmacotherapy in patients with autism by assessing predictors of efficacy, tolerability, and safety. This randomized double-blind parallel-group study was conducted in three academic medical centers and a single private pediatric practice. Eighty children or adolescents (aged 6-17 yrs) with autistic disorder were enrolled, and 61 patients were randomized to the study drug. Of those patients, 51 completed the 10-week trial, and 31 completed an optional 12-week blinded extension phase. All patients were treated with 2 weeks of placebo before random assignment to receive aripiprazole (31 patients) or risperidone (30 patients) for 10 weeks. Sixteen placebo responders (20%) were excluded from further analysis. Drug dosing followed U.S. Food and Drug Administration (FDA) labeling, and weekly dosage adjustments were allowed until week 4; patients were then maintained on a fixed dose for 6 additional weeks. Safety, physical, and psychological assessments were recorded weekly or every 2 weeks. No significant differences in severity of illness between the aripiprazole and risperidone groups were noted at baseline. All patients significantly improved on the Aberrant Behavior Checklist-Irritability subscale after 1 week and continued for the remaining 9 weeks and the extension phase. Improvement was greatest in the risperidone group at every assessment period and was statistically significantly better than that in the aripiprazole group at weeks 3 and 6 (p<0.05). No dose-limiting adverse events occurred during the dose-titration period. Mean weight gain in the aripiprazole group was significantly less than that in the risperidone group at week 4 (0.62 vs 1.38 kg, p=0.033) and week 10 (1.61 vs 3.31 kg, p<0.001), but the difference became nonsignificant for the 31 patients completing the 3-month extension phase (4.36 vs 5.55 kg, p=0.26). Pharmacotherapy of patients with autism spectrum disorder resulted in behavioral improvement within 1 week and lasted at least 22 weeks. Weight gain occurred to a greater degree with risperidone than aripiprazole initially, but the differences became nonsignificant by the end of the trial. Our trial supports previous results of drug efficacy and safety in patients with autism spectrum disorder from other trials and extends the evidence-based support for choosing an FDA-approved drug for initial pharmacotherapy for autism spectrum disorder.

Project description:BackgroundAutism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions can reduce treatment costs and promote healthy lifestyle changes. These therapies can be adjunctive or replace traditional treatments. However, issues with cooperation and compliance prevent preschool patients with ASD from applying these tools. In this open-label, randomized controlled trial, we developed a nonwearable digital therapy called virtual reality-incorporated cognitive behavioral therapy (VR-CBT).ObjectiveThe aim of this study was to assess the adjunctive function of VR-CBT by comparing the effects of VR-CBT plus learning style profile (LSP) intervention with those of LSP-only intervention in preschool children with ASD.MethodsThis trial was performed in China on 78 preschool children (age 3-6 years, IQ>70) diagnosed with ASD who were randomized to receive a 20-week VR-CBT plus LSP intervention (intervention group, 39/78, 50%) or LSP intervention only (control group, 39/78, 50%). The primary outcome was the change of scores from baseline to week 20, assessed by using the parent-rated Autism Behavior Checklist (ABC). Secondary outcomes included the Childhood Autism Rating Scale (CARS), Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV), and behavioral performance data (accuracy and reaction time) in go/no-go tasks. All primary and secondary outcomes were analyzed in the intention-to-treat population.ResultsAfter the intervention, there was an intervention effect on total ABC (β=-5.528; P<.001) and CARS scores (β=-1.365; P=.02). A similar trend was observed in the ABC subscales: sensory (β=-1.133; P=.047), relating (β=-1.512; P=.03), body and object use (β=-1.211; P=.03), and social and self-help (β=-1.593; P=.03). The intervention also showed statistically significant effects in improving behavioral performance (go/no-go task, accuracy, β=2.923; P=.04). Moreover, a significant improvement of ADHD hyperactivity-impulsivity symptoms was observed in 53 children with comorbid ADHD based on ADHD-RS-IV (β=-1.269; P=.02). No statistically significant intervention effect was detected in the language subscale of ABC (β=-.080; P=.83). Intervention group girls had larger improvements in ABC subscales, that is, sensory and body and object use and in the CARS score and accuracy of go/no-go task (all P<.05) than the control group girls. Statistically significant intervention effects could be observed in hyperactivity-impulsivity symptoms in the intervention group boys with comorbid ADHD compared with those in the control group boys (β=-1.333; P=.03).ConclusionsWe found potentially positive effects of nonwearable digital therapy plus LSP on core symptoms associated with ASD, leading to a modest improvement in the function of sensory, motor, and response inhibition, while reducing impulsivity and hyperactivity in preschoolers with both ASD and ADHD. VR-CBT was found to be an effective and feasible adjunctive digital tool.Trial registrationChinese Clinical Trial Registry ChiCTR2100053165; http://www.chictr.org.cn/showproj.aspx?proj=137016.

Dataset Information

Cluster randomized trial of the classroom SCERTS intervention for elementary students with autism spectrum disorder.

Publications

Cluster randomized trial of the classroom SCERTS intervention for elementary students with autism spectrum disorder.

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