A Randomized, Community-Based Feasibility Trial of Modified ESDM for Toddlers with Suspected Autism.
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ABSTRACT:
SUBMITTER: Mirenda P
PROVIDER: S-EPMC8754545 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
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A Randomized, Community-Based Feasibility Trial of Modified ESDM for Toddlers with Suspected Autism.
Mirenda Pat P Colozzo Paola P Smith Veronica V Kroc Ed E Kalynchuk Karen K Rogers Sally J SJ Ungar Wendy J WJ
Journal of autism and developmental disorders 20220113 12
A randomized feasibility trial of a parent coaching (PC) intervention was conducted across 16 community agencies in a Canadian province. Parents of toddlers with suspected autism were assigned to either a PC group (n = 24) or an enhanced community treatment (ECT) group (n = 25). PC participants received 24 weeks of coaching support from community service providers trained in the project. Children in both groups also received available community services and supplementary materials. PC children m ...[more]
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Project description:This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.
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Project description:Study questionAre toddlers conceived by fertility treatment at higher risk of failing a screening tool for autism spectrum disorders (ASD) than toddlers not conceived by treatment?Summary answerCompared with children not conceived by infertility treatment, children conceived by any infertility treatment, ovulation induction with or without intrauterine insemination (OI/IUI), or assisted reproductive technologies (ART) appeared to have had higher odds of failing an ASD screening; however, results were inconclusive and need replication.What is known alreadyAlthough most of the studies which have examined risk of ASD after ART show no association, the results are mixed. Thus, further studies are needed to clarify this association.Study design size, durationThe Upstate KIDS Study is a population-based, prospective cohort study of children born in New York State between 2008 and 2010. Children were screened for ASD using the Modified Checklist for Autism in Toddlers (M-CHAT) at ages 18 and 24 months.Participants/materials, setting, and methodsThe New York State live-birth registry was used to identify newborns conceived with and without fertility treatment with a 1:3 ratio, frequency matched on region of birth. At 18 and 24 months, 3183 and 3063 mothers, respectively, completed the M-CHAT questionnaire. The current analysis included 2586 singletons and 1296 twins with M-CHAT information at 18 and/or 24 months. Multivariable logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (aOR) and 95% confidence intervals (CI) after adjustment for covariates such as maternal age, education and plurality.Main results and the role of chanceWe found that 200 (5.2%) and 115 (3.0%) children failed the M-CHAT at 18 and 24 months, respectively. The associations between use of infertility treatment and failing the M-CHAT at 18 and/or 24 months were positive but inconclusive as they failed to exclude no association (18 months aOR 1.71, 95% CI: 0.81-3.61; 24 months aOR 1.78, 95% CI: 0.66-4.81; and both 18 and 24 months aOR 1.53, 95% CI: 0.78-2.99). The relationships between OI/IUI and ART with M-CHAT failure at 18 and/or 24 months were similar to those of using any fertility treatment. In vitro fertilization with intracytoplasmic sperm injection was not consistently positively or inversely associated with M-CHAT failure at each time point (18 months aOR 1.20, 95% CI: 0.51-2.83; 24 months aOR 0.93, 95% CI: 0.37-2.31; and both 18 and 24 months aOR 1.09, 95% CI: 0.50-2.60).Limitations reasons for cautionThe M-CHAT is a screening tool used for ASD risk assessment, and therefore, M-CHAT failure does not indicate ASD diagnosis. In addition, we did not have power to detect associations of small magnitude. Finally, non-response to follow-up may bias the results.Wider implications of the findingsDespite lack of precision, the positive associations between ART and M-CHAT failure suggest that larger population-based studies with longer follow-up are needed.Study funding/competing interest(s)Supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD; contracts HHSN275201200005C, HHSN267200700019C). The sponsor played no role in the study design, data collection, data analysis or interpretation, writing of the manuscript or decision to submit the article for publication. There are no conflicts of interest to declare.Trial registration numberNot applicable.
| S-EPMC8489552 | biostudies-literature
Project description:To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD).Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community.Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD: 15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group.This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism.
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Project description:ObjectiveTo examine the classification rates and screening properties, including sensitivity and specificity, of the web-based Modified Checklist for Autism in Toddler, Revised with Follow-Up (M-CHAT-R/F) compared with paper-phone administration, and to determine the extent to which electronic M-CHAT-R/F streamlines screening, increases screening fidelity, increases diagnostic evaluation participation, and decreases waiting time from screening to evaluation compared with paper-phone modality.Study designPrimary-care practices in urban and suburban settings administered either the web-based or paper-phone M-CHAT-R/F using a prospective nonrandomized control design. Toddlers (n = 17 900) were screened between 2009 and 2016 at routine well-child check-ups. Toddlers who screened at risk on the M-CHAT-R/F were invited to complete diagnostic evaluations; 176 children were diagnosed with autism. The χ2, Fisher exact, and t-tests, as well as regression and screening properties, were used to compare outcome distributions, screening properties, and implementation by modality.ResultsClassification rates of the initial M-CHAT-R into low, medium, and high risk were significantly different across modalities with very small effect sizes. Sensitivity and specificity were high across both modalities. For children in the medium-risk range, the web-based modality had a greater rate of predicting risk for autism after Follow-Up compared with the paper-phone modality, and the web eliminated delay between initial screen and Follow-Up. The web-based modality showed increased screening fidelity, no data loss, and similar rates of evaluation attendance and time to evaluation from Follow-Up administration.ConclusionsThe web-based M-CHAT-R/F is a valid tool for universal autism screening. Systems-level decisions should balance the increased feasibility of the electronic administration with the increase in Follow-Up accuracy provided by skilled clinician interview.
| S-EPMC10390646 | biostudies-literature
Project description:BackgroundThere is growing recognition of the importance of reporting preliminary work on the feasibility of a trial. The present study aimed to assess the feasibility of (1) a proposed fitness testing battery, and (2) processes related to the implementation of cancer-specific exercise programming in a community setting.Methods/designA randomized controlled implementation feasibility trial was performed in advance of a large-scale implementation study. Eligible participants within 18 months of a cancer diagnosis were randomized to immediate or delayed community-based exercise at YMCA locations in Calgary and Edmonton, Canada for an 8-week period. The primary outcome for the trial was the feasibility of the physical fitness testing battery, defined as a 70% or greater completion rate across the 24-week study period. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to evaluate processes related to implementation of the exercise program across the two sites.ResultsEighty participants were recruited, 73 (91%) completed the 8-week trial, and 68 (85%) completed the 16- and 24-week follow-ups. Sixty participants (75%) completed the full physical fitness test battery at each time point, and 59 (74%) completed the patient-reported outcome measures. Statistically significant between-group differences were found in favor of the exercise group for functional aerobic capacity, upper and lower extremity strength, and symptoms. Differences were found between the sites, however, in completion rates and processes related to program implementation.DiscussionFindings suggest the need for minor adaptations to the physical fitness battery and outcome measures to better fit the community context. While findings support feasibility, context-specific challenges related to implementation processes were identified.
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Project description:ObjectiveThe purpose of the study was to examine use of the Modified Checklist for Autism in Toddlers (M-CHAT) as an autism-specific screening instrument in a large, geographically diverse pediatrics-based sample.MethodsThe M-CHAT and the M-CHAT Follow-Up (M-CHAT/F) were used to screen 18,989 toddlers at pediatric well-child visits in 2 US geographic regions. Pediatricians directly referred children to ascertain potential missed screening cases. Screen-positive children received the M-CHAT/F; children who continued to screen positive after the M-CHAT/F received a diagnostic evaluation.ResultsResults indicated that 54% of children who screened positive on the M-CHAT and M-CHAT/F presented with an autism spectrum disorder (ASD), and 98% presented with clinically significant developmental concerns warranting intervention. An M-CHAT total score cutoff of ?3 identifies nearly all screen-positive cases, and for ease of scoring the use of only the M-CHAT total score cutoff is recommended. An M-CHAT total score of 7 serves as an appropriate clinical cutoff, and providers can bypass the M-CHAT/F and refer immediately to evaluation and intervention if a child obtains a score of ?7.ConclusionsThis study provides empirical support for the utility of population screening for ASD with the use of the M-CHAT in a primary care setting. Results suggest that the M-CHAT continues to be an effective screening instrument for ASD when the 2-step screening process is used. The M-CHAT is widely used at pediatric offices, and this study provides updated results to facilitate use and scoring of the M-CHAT by clinical providers.
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Project description:PurposeTelemedicine approaches to autism (ASD) assessment have become increasingly common, yet few validated tools exist for this purpose. This study presents results from a clinical trial investigating two approaches to tele-assessment for ASD in toddlers.Methods144 children (29% female) between 17 and 36 months of age (mean = 2.5 years, SD = 0.33 years) completed tele-assessment using either the TELE-ASD-PEDS (TAP) or an experimental remote administration of the Screening Tool for Autism in Toddlers (STAT). All children then completed traditional in-person assessment with a blinded clinician, using the Mullen Scales of Early Learning (MSEL), Vineland Adaptive Behavior Scales, 3rd Edition (VABS-3), and Autism Diagnostic Observation Schedule (ADOS-2). Both tele-assessment and in-person assessment included a clinical interview with caregivers.ResultsResults indicated diagnostic agreement for 92% of participants. Children diagnosed with ASD following in-person assessment who were missed by tele-assessment (n = 8) had lower scores on tele- and in-person ASD assessment tools. Children inaccurately identified as having ASD by tele-assessment (n = 3) were younger than other children and had higher developmental and adaptive behavior scores than children accurately diagnosed with ASD by tele-assessment. Diagnostic certainty was highest for children correctly identified as having ASD via tele-assessment. Clinicians and caregivers reported satisfaction with tele-assessment procedures.ConclusionThis work provides additional support for the use of tele-assessment for identification of ASD in toddlers, with both clinicians and families reporting broad acceptability. Continued development and refinement of tele-assessment procedures is recommended to optimize this approach for the needs of varying clinicians, families, and circumstances.
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Project description:BackgroundSocial 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).MethodsFifty 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.ResultsA 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.ConclusionsThis 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.
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Project description:This study aimed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism. The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later. Compared to caregivers and toddlers randomized to the waitlist control group the immediate treatment (IT) group made significant improvements in targeted areas of joint engagement. The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention. These are among the first randomized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism. Clinical Trials #: NCT00065910.
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Project description:BackgroundThe increased prevalence of Autism Spectrum Disorder (ASD) diagnoses in combination with psychiatric comorbidity, has led to an increased need for effective interventions. The evidence for internet-based interventions for several mental health problems is established but has not been evaluated for adults with ASD.ObjectiveThe aim of this randomized controlled trial is to evaluate the feasibility and effects of an internet-based intervention targeting quality of life and psychiatric symptoms (depression and anxiety) in adults with ASD.Methods84 participants were randomly allocated to intervention (n = 42) or control (n = 42). The 18-week internet-based intervention covered a range of themes related to difficulties common in ASD, and exercises based on cognitive behavioral strategies. Participants were provided with individual feedback following each module and were invited to regular chat sessions with peer participants. The primary outcomes were subjective quality of life and sense of coherence, and secondary outcomes were symptoms of depression and anxiety. All outcomes were measured at five occasions and analysed with linear mixed effect models. Participant satisfaction and adherence was also analysed.ResultsParticipant satisfaction and adherence was satisfactory but no significant interaction between group and time was found for any outcome measure. Autistic traits were negatively related to quality of life and sense of coherence and positively related to anxiety and depressive symptoms.ConclusionsThis internet-based intervention showed feasibility regarding adherence and participant satisfaction. However, no significant effects on quality of life, sense of coherence or psychiatric symptoms were found, likely due to limitations in the design and methodology of this specific trial in combination to the heterogeneity of the group. Individuals with ASD may require interventions that are flexible and individually tailored in regard to both format, content and therapeutic support. The current trial provides useful information and suggestions for the future research on internet-based interventions for ASD.
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