Choosing Performance-Based Outcome Measures of Daily Living Skills and Socialization for Clinical Trials in Autistic Children.

IMPORTANCE: Robust and psychometrically sound performance-based outcome measures are needed for clinical trials of occupational therapy interventions for children with autism. OBJECTIVE: To demonstrate a systematic approach for choosing psychometrically sound performance-based outcome measures of daily living skills and socialization for use in clinical trials of occupational therapy interventions for children with autism. DESIGN: Rapid literature review to identify appropriate measures for studies with this population followed by quality indicator ratings and a nominal group process. SETTING: University. PARTICIPANTS: Four experts in autism and pediatric outcome measurement. Outcomes and Measures: Twenty-one outcome measures of daily living skills and socialization were identified and reviewed. RESULTS: Seven measures met the inclusion criteria. The Assessment of Motor and Process Skills and the Evaluation of Social Interaction-Second Edition, received the highest ratings and group consensus. Several other measures were also scored highly. CONCLUSIONS AND RELEVANCE: Careful assessment of psychometric properties is an important component of choosing outcome measures for a clinical trial, but burden of assessment and study objectives are important considerations. What This Article Adds: This project demonstrates use of a systematic process for choosing outcome measures for a planned clinical trial.

Efficacy of Occupational Therapy Using Ayres Sensory Integration®: A Systematic Review.

This systematic review addresses the question "What is the efficacy of occupational therapy using Ayres Sensory Integration® (ASI) to support functioning and participation as defined by the International Classification of Functioning, Disability and Health for persons with challenges in processing and integrating sensory information that interfere with everyday life participation?" Three randomized controlled trials, 1 retroactive analysis, and 1 single-subject ABA design published from 2007 to 2015, all of which happened to study children with autism, met inclusion criteria. The evidence is strong that ASI intervention demonstrates positive outcomes for improving individually generated goals of functioning and participation as measured by Goal Attainment Scaling for children with autism. Moderate evidence supported improvements in impairment-level outcomes of improvement in autistic behaviors and skills-based outcomes of reduction in caregiver assistance with self-care activities. Child outcomes in play, sensory-motor, and language skills and reduced caregiver assistance with social skills had emerging but insufficient evidence.

Sensory Phenotypes in Autism: Making a Case for the Inclusion of Sensory Integration Functions.

Sensory features are part of the diagnostic criteria for autism and include sensory hypo/hyper reactivity and unusual sensory interest; however, additional sensory differences, namely differences in sensory integration, have not been routinely explored. This study characterized sensory integration differences in a cohort of children (n = 93) with a confirmed diagnosis of autism (5-9 years) using a standardized, norm-referenced battery. Mean z scores, autism diagnostic scores, and IQ are reported. Participants showed substantial deficits in tactile perception, praxis, balance, visual perception, and visual-motor skills. Relationship with autism diagnostic test scores were weak or absent. Findings suggest additional sensory difficulties that are not typically assessed or considered when characterizing sensory features in autism. These data have implications for a greater understanding of the sensory features in the autism phenotype and the development of personalized treatments.

Examining the Latent Structure and Correlates of Sensory Reactivity in Autism: A Multi-site Integrative Data Analysis by the Autism Sensory Research Consortium.

Background Differences in responding to sensory stimuli, including sensory hyperreactivity (HYPER), hyporeactivity (HYPO), and sensory seeking (SEEK) have been observed in autistic individuals across sensory modalities, but few studies have examined the structure of these "supra-modal" traits in the autistic population. Methods Leveraging a combined sample of 3,868 autistic youth drawn from 12 distinct data sources (ages 3-18 years and representing the full range of cognitive ability), the current study used modern psychometric and meta-analytic techniques to interrogate the latent structure and correlates of caregiver-reported HYPER, HYPO, and SEEK within and across sensory modalities. Bifactor statistical indices were used to both evaluate the strength of a "general response pattern" factor for each supra-modal construct and determine the added value of "modality-specific response pattern" scores (e.g., Visual HYPER). Bayesian random-effects integrative data analysis models were used to examine the clinical and demographic correlates of all interpretable HYPER, HYPO and SEEK (sub)constructs. Results All modality-specific HYPER subconstructs could be reliably and validly measured, whereas certain modality-specific HYPO and SEEK subconstructs were psychometrically inadequate when measured using existing items. Bifactor analyses unambiguously supported the validity of a supra-modal HYPER construct (ω H = .800), whereas a coherent supra-modal HYPO construct was not supported (ω H = .611), and supra-modal SEEK models suggested a more limited version of the construct that excluded some sensory modalities (ω H = .799; 4/7 modalities). Within each sensory construct, modality-specific subscales demonstrated substantial added value beyond the supra-modal score. Meta-analytic correlations varied by construct, although sensory features tended to correlate most strongly with other domains of core autism features and co-occurring psychiatric symptoms. Certain subconstructs within the HYPO and SEEK domains were also associated with lower adaptive behavior scores. Limitations: Conclusions may not be generalizable beyond the specific pool of items used in the current study, which was limited to parent-report of observable behaviors and excluded multisensory items that reflect many "real-world" sensory experiences. Conclusion Psychometric issues may limit the degree to which some measures of supra-modal HYPO/SEEK can be interpreted. Depending on the research question at hand, modality-specific response pattern scores may represent a valid alternative method of characterizing sensory reactivity in autism.

Examining the latent structure and correlates of sensory reactivity in autism: a multi-site integrative data analysis by the autism sensory research consortium.

BACKGROUND: Differences in responding to sensory stimuli, including sensory hyperreactivity (HYPER), hyporeactivity (HYPO), and sensory seeking (SEEK) have been observed in autistic individuals across sensory modalities, but few studies have examined the structure of these "supra-modal" traits in the autistic population. METHODS: Leveraging a combined sample of 3868 autistic youth drawn from 12 distinct data sources (ages 3-18 years and representing the full range of cognitive ability), the current study used modern psychometric and meta-analytic techniques to interrogate the latent structure and correlates of caregiver-reported HYPER, HYPO, and SEEK within and across sensory modalities. Bifactor statistical indices were used to both evaluate the strength of a "general response pattern" factor for each supra-modal construct and determine the added value of "modality-specific response pattern" scores (e.g., Visual HYPER). Bayesian random-effects integrative data analysis models were used to examine the clinical and demographic correlates of all interpretable HYPER, HYPO, and SEEK (sub)constructs. RESULTS: All modality-specific HYPER subconstructs could be reliably and validly measured, whereas certain modality-specific HYPO and SEEK subconstructs were psychometrically inadequate when measured using existing items. Bifactor analyses supported the validity of a supra-modal HYPER construct (ωH = .800) but not a supra-modal HYPO construct (ωH = .653), and supra-modal SEEK models suggested a more limited version of the construct that excluded some sensory modalities (ωH = .800; 4/7 modalities). Modality-specific subscales demonstrated significant added value for all response patterns. Meta-analytic correlations varied by construct, although sensory features tended to correlate most with other domains of core autism features and co-occurring psychiatric symptoms (with general HYPER and speech HYPO demonstrating the largest numbers of practically significant correlations). LIMITATIONS: Conclusions may not be generalizable beyond the specific pool of items used in the current study, which was limited to caregiver report of observable behaviors and excluded multisensory items that reflect many "real-world" sensory experiences. CONCLUSION: Of the three sensory response patterns, only HYPER demonstrated sufficient evidence for valid interpretation at the supra-modal level, whereas supra-modal HYPO/SEEK constructs demonstrated substantial psychometric limitations. For clinicians and researchers seeking to characterize sensory reactivity in autism, modality-specific response pattern scores may represent viable alternatives that overcome many of these limitations.

Notes from an epicenter: navigating behavioral clinical trials on autism spectrum disorder amid the COVID-19 pandemic in the Bronx.

BACKGROUND: The COVID-19 pandemic impacted nearly all facets of our daily lives, and clinical research was no exception. Here, we discuss the impact of the pandemic on our ongoing, three-arm randomized controlled trial (RCT) Sensory Integration Therapy (SIT) in Autism: Mechanisms and Effectiveness (NCT02536365), which investigates the immediate and sustained utility of SIT to strengthen functional daily-living skills and minimize the presence of maladaptive sensory behaviors in autistic children. MAIN TEXT: In this text, we detail how we navigated the unique challenges that the pandemic brought forth between the years 2020 and 2021, including the need to rapidly adjust our study protocol, recruitment strategy, and in-person assessment battery to allow for virtual recruitment and data collection. We further detail how we triaged participants and allocated limited resources to best preserve our primary outcome measures while prioritizing the safety of our participants and study team. We specifically note the importance of open and consistent communication with all participating families throughout the pandemic in ensuring all our protocol adjustments were successfully implemented. CONCLUSIONS: Though the COVID-19 pandemic resulted in an unprecedented interruption to in-person clinical research, clinical trials have always been and will continue to be at risk for unforeseen interruptions, whether from world events or participants' personal circumstances. By presenting our steps to preserving this RCT throughout the pandemic, we offer suggestions for successfully managing unexpected interruptions to research. Ideally, by taking these into account, future RCTs may be increasingly prepared to minimize the impact of these potential interruptions to research.

A Randomized Controlled Trial of Progressively Reduced Nicotine Content Cigarettes on Smoking Behaviors, Biomarkers of Exposure, and Subjective Ratings.

BACKGROUND: The U.S. FDA has the authority to reduce cigarette nicotine content if found to benefit public health. Reduced nicotine content (RNC) cigarette use does not appear to increase harm exposure, but studies have not rigorously assessed smoking behavior or used a comprehensive panel of biomarkers. This study examined the effects of progressively decreasing RNC cigarettes on smoking behaviors, biomarkers of exposure, and subjective ratings. METHODS: One hundred and fifty-eight daily, non-treatment-seeking smokers participated in a 35-day randomized, unblinded, parallel study. After a 5-day baseline period, participants were randomly assigned to an experimental group (n = 80) that smoked progressively decreasing RNC cigarettes during three 10-day periods, or control group (n = 78) that smoked their own brand throughout the study. RESULTS: Daily cigarette consumption significantly increased for the intermediate RNCs (P's < 0.001) but approached baseline rate for the lowest RNC (P = 0.686); in contrast, puffing behavior significantly decreased at intermediate levels and increased for the lowest RNC (P's < 0.001). Cotinine and NNAL significantly decreased by RNC period (P's ≤ 0.001-0.02), whereas CO boost initially increased (P's = 0.001-0.005). 1-HOP did not change by period (P = 0.109). CONCLUSIONS: Smoking behaviors changed by RNC period via CPD and puffing behavior. Biomarkers of exposure generally decreased with nicotine content. IMPACT: Findings suggest that RNC use does not ubiquitously reduce smoking behaviors or biomarkers, yet the lowest RNC level tested may reduce harm exposure. This emphasizes the importance of using multiple behavioral and biologic measures to address the impact of RNC cigarette smoking. Cancer Epidemiol Biomarkers Prev; 25(7); 1125-33. ©2016 AACR.

Graphic-enhanced information improves perceived risks of cigar smoking.

The Internet is a major source of health information and several notable health web sites contain information on the risks associated with cigar smoking. Previous research indicates that Internet pages containing health information on cigars have high reading levels and are restricted to text material, which can decrease understanding. We examined the effects of existing text-only (from the United States National Cancer Institute website) versus novel graphic-enhanced information on smokers' perceptions of health risks associated with cigar smoking. The study was a laboratory-based single session of current cigarette smokers (n=102) who viewed cigar smoking risk information on a computer monitor then completed cigar risk questionnaire items. Participants were randomized to view either text-only or graphic-enhanced cigar information. The graphic version contained additional risk information about cigarillos and little cigars. Text-only participants were more likely to underestimate perceived health risks associated with cigar smoking compared to graphic-enhanced participants (47.1% versus 17.7%, p=.001); and, graphic-enhanced participants were more likely to report that they would share the cigar health risk information with friends compared to those viewing text-only, 47.0% versus 27.4%, p=.005. Employing graphics to convey health risks associated with cigar smoking increases understanding and likeliness to share information. Integrating information about little cigar and cigarillo risk in conjunction with large cigar risk information is an effective public health strategy to provide more comprehensive risk information. Utilizing graphics on health information internet pages can increase knowledge and perceived risks of cigar smoking.