Safe inhalation pipe provision (SIPP): protocol for a mixed-method evaluation of an intervention to improve health outcomes and service engagement among people who use crack cocaine in England.

BACKGROUND: Over 180,000 people use crack cocaine in England, yet provision of smoking equipment to support safer crack use is prohibited under UK law. Pipes used for crack cocaine smoking are often homemade and/or in short supply, leading to pipe sharing and injuries from use of unsafe materials. This increases risk of viral infection and respiratory harm among a marginalised underserved population. International evaluations suggest crack pipe supply leads to sustained reductions in pipe sharing and use of homemade equipment; increased health risk awareness; improved service access; reduction in injecting and crack-related health problems. In this paper, we introduce the protocol for the NIHR-funded SIPP (Safe inhalation pipe provision) project and discuss implications for impact. METHODS: The SIPP study will develop, implement and evaluate a crack smoking equipment and training intervention to be distributed through peer networks and specialist drug services in England. Study components comprise: (1) peer-network capacity building and co-production; (2) a pre- and post-intervention survey at intervention and non-equivalent control sites; (3) a mixed-method process evaluation; and (4) an economic evaluation. Participant eligibility criteria are use of crack within the past 28 days, with a survey sample of ~ 740 for each impact evaluation survey point and ~ 40 for qualitative process evaluation interviews. Our primary outcome measure is pipe sharing within the past 28 days, with secondary outcomes pertaining to use of homemade pipes, service engagement, injecting practice and acute health harms. ANTICIPATED IMPACT: SIPP aims to reduce crack use risk practices and associated health harms; including through increasing crack harm reduction awareness among service providers and peers. Implementation has only been possible with local police approvals. Our goal is to generate an evidence base to inform review of the legislation prohibiting crack pipe supply in the UK. This holds potential to transform harm reduction service provision and engagement nationally. CONCLUSION: People who smoke crack cocaine in England currently have little reason to engage with harm reduction and drug services. Little is known about this growing population. This study will provide insight into population characteristics, unmet need and the case for legislative reform. TRIAL REGISTRATION: ISRCTN12541454  https://doi.org/10.1186/ISRCTN12541454.

Commentary: Best practices and processes for assessment of autism spectrum disorder - the intended role of standardized diagnostic instruments.

Development of standardized diagnostic instruments has facilitated the systematic characterization of individuals with autism spectrum disorders (ASD) in clinical and research settings. However, overemphasis on scores from specific instruments has significantly detracted from the original purpose of these tools. Rather than provide a definitive "answer," or even a confirmation of diagnosis, standardized diagnostic instruments were designed to aid clinicians in the process of gathering information about social communication, play, and repetitive and sensory behaviors relevant to diagnosis and treatment planning. Importantly, many autism diagnostic instruments are not validated for certain patient populations, including those with severe vision, hearing, motor, and/or cognitive impairments, and they cannot be administered via a translator. In addition, certain circumstances, such as the need to wear personal protective equipment (PPE), or behavioral factors (e.g., selective mutism) may interfere with standardized administration or scoring procedures, rendering scores invalid. Thus, understanding the uses and limitations of specific tools within specific clinical or research populations, as well as similarities or differences between these populations and the instrument validation samples, is paramount. Accordingly, payers and other systems must not mandate the use of specific tools in cases when their use would be inappropriate. To ensure equitable access to appropriate assessment and treatment services, it is imperative that diagnosticians be trained in best practice methods for the assessment of autism, including if, how, and when to appropriately employ standardized diagnostic instruments.

The Brief Observation of Symptoms of Autism (BOSA): Development of a New Adapted Assessment Measure for Remote Telehealth Administration Through COVID-19 and Beyond.

Interest in telehealth assessment for autism has increased due to COVID-19 and subsequent expansion of remote psychological services, though options that are easy for clinicians to adopt and available through the lifespan are limited. The Brief Observation of Symptoms of Autism (BOSA) provides a social context with standardized materials and activities that can be coded by clinicians trained in the Autism Diagnostic Observation Schedule. The current project examined psychometric properties to determine optimal use for each BOSA version. Three hundred and seven participants with 453 BOSAs were included to determine best performing items for algorithms, validity, sensitivity, specificity, recommended cut-offs, and proposed ranges of concern. While preliminary, the BOSA provides a promising new option for telehealth-administered assessment for autism.

The Adapted ADOS: A New Module Set for the Assessment of Minimally Verbal Adolescents and Adults.

Few measures are appropriate to assess autism symptoms in minimally verbal adolescents and adults. The Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2, Lord et al., in Autism diagnostic observation schedule-2nd edition (ADOS-2). Western Psychological Services, Los Angeles, 2012) Modules 1 and 2 were designed and validated with children whose spoken language ranges from few- to- no words to phrase speech. This study describes the development and initial validation of the Adapted-ADOS (A-ADOS), which includes tasks, materials and behavioral codes modified to be suitable for assessing older minimally verbal individuals. A-ADOS algorithms exhibit comparable sensitivity and improved specificity relative to ADOS-2 Modules 1 and 2. Although further validation is needed, the A-ADOS will facilitate research to further understanding of minimally verbal adults and symptom trajectories across the lifespan.

Simple, Transparent, and Flexible Automated Quality Assessment Procedures for Ambulatory Electrodermal Activity Data.

OBJECTIVE: Electrodermal activity (EDA) is a noninvasive measure of sympathetic activation often used to study emotions, decision making, and health. The use of "ambulatory" EDA in everyday life presents novel challenges-frequent artifacts and long recordings-with inconsistent methods available for efficiently and accurately assessing data quality. We developed and validated a simple, transparent, flexible, and automated quality assessment procedure for ambulatory EDA data. METHODS: A total of 20 individuals with autism (5 females, 5-13 years) provided a combined 181 h of EDA data in their home using the Affectiva Q Sensor across 8 weeks. Our procedure identified invalid data using four rules: First, EDA out of range; second, EDA changes too quickly; third, temperature suggests the sensor is not being worn; and fourth, transitional data surrounding segments identified as invalid via the preceding rules. We identified invalid portions of a pseudorandom subset of our data (32.8 h, 18%) using our automated procedure and independent visual inspection by five EDA experts. RESULTS: Our automated procedure identified 420 min (21%) of invalid data. The five experts agreed strongly with each other (agreement: 98%, Cohen's κ: 0.87) and, thus, were averaged into a "consensus" rating. Our procedure exhibited excellent agreement with the consensus rating (sensitivity: 91%, specificity: 99%, accuracy: 92%, κ: 0.739 [95% CI = 0.738, 0.740]). CONCLUSION: We developed a simple, transparent, flexible, and automated quality assessment procedure for ambulatory EDA data. SIGNIFICANCE: Our procedure can be used beyond this study to enhance efficiency, transparency, and reproducibility of EDA analyses, with free software available at http://www.cbslab.org/EDAQA.

The relationship between treatment attendance, adherence, and outcome in a caregiver-mediated intervention for low-resourced families of young children with autism spectrum disorder.

Rates of participation in intervention research have not been extensively studied within autism spectrum disorder. Such research is important given the benefit of early intervention on long-term prognosis for children with autism spectrum disorder. The goals of this study were to examine how family demographic factors predicted treatment attendance and adherence in a caregiver-mediated randomized controlled trial targeting core deficits of autism spectrum disorder, and whether treatment attendance and adherence predicted outcome. In all, 147 caregiver-child dyads from a low-resourced population were randomized to in-home caregiver-mediated module or group-based caregiver education module treatment. Treatment attendance, adherence, and outcome (time spent in joint engagement) were the primary outcome variables. The majority of families who entered treatment (N = 87) maintained good attendance. Attendance was significantly predicted by socioeconomic status, site, and treatment condition. Families in caregiver-mediated module reported lower levels of treatment adherence, which was significantly predicted by site, condition, caregiver stress, and child nonverbal intelligence quotient. Dyads in caregiver-mediated module had significantly longer interactions of joint engagement, which was significantly predicted by an interaction between treatment attendance and condition. Overall, the results from this study stress the importance of considering demographic variables in research design when considering barriers to treatment attendance and adherence.

Caregiver-mediated intervention for low-resourced preschoolers with autism: an RCT.

OBJECTIVES: To compare 2 short-term, community caregiver training interventions for preschool-aged children with Autism Spectrum Disorder who had low resources. Low resource was defined by the US Department of Housing and Urban Development low-income index or 1 "indicator," (e.g., Medicaid eligibility). Child outcomes focused on joint engagement, joint attention, and play. METHODS: Participants included 112 families of a child who had Autism Spectrum Disorder who met criteria for being low-resourced and who were randomly assigned to 1 of 2 3-month interventions, group caregiver education or individualized caregiver-mediated intervention (CMM). Children were assessed for social communication skills pre- and post-treatment, and followed up at 3 months. RESULTS: All children improved in joint engagement and initiating joint attention, with significantly greater improvement by the CMM group. Outcomes on play skills were mixed, with improvement of symbolic play for the CMM group and no change in functional play skills. Joint engagement maintained over time for the CMM group, and initiating joint attention maintained for both groups over time. CONCLUSIONS: This study is among the first randomized trials comparing 2 active interventions with a large sample of low-resourced families. Results suggest improvements in core autism deficits of joint engagement, joint attention, and symbolic play with relatively brief, caregiver-mediated interventions, but additional support is necessary to maintain and generalize these gains over time.

Life course socioeconomic adversity and age at natural menopause in women from Latin America and the Caribbean.

OBJECTIVE: The aim of this study was to assess the association between life course socioeconomic adversity and age at menopause in Latin America and the Caribbean. METHODS: Data from 4,056 women aged 60 to 79 years randomly selected from seven cities in Latin America and the Caribbean were analyzed. Cox proportional hazards models were used to estimate the probability of age at menopause by indicators of life course socioeconomic adversity. RESULTS: Median age at menopause was 50 years. The following life course socioeonomic indicators were associated with earlier age at menopause: low education (hazard ratio [HR], 1.16; 95% CI, 1.07-1.26) and manual occupation/housewives (HR, 1.12; 95% CI, 1.03-1.20). Other factors associated with earlier age at menopause were current smoking (HR, 1.14; 95% CI, 1.03-1.27), nulliparity (HR, 1.14; 95% CI, 1.02-1.28), and multiparity (five children or more; HR, 1.15; 95% CI, 1.06-1.24). There was a cumulative effect of socioeconomic adversities across the life course. The median age at menopause was lower for women with six indicators of life course socioeconomic adversity compared with women with no adversities (HR, 1.40; 95% CI, 1.10-1.77). CONCLUSIONS: Median age at menopause occurs several years earlier in women from Latin America and the Caribbean compared with women from high-income countries. The results support the association between life course socioeconomic adversity and age at menopause.

Clinical assessment and management of toddlers with suspected autism spectrum disorder: insights from studies of high-risk infants.

With increased public awareness of the early signs and recent American Academy of Pediatrics recommendations that all 18- and 24-month-olds be screened for autism spectrum disorders, there is an increasing need for diagnostic assessment of very young children. However, unique challenges exist in applying current diagnostic guidelines for autism spectrum disorders to children under the age of 2 years. In this article, we address challenges related to early detection, diagnosis, and treatment of autism spectrum disorders in this age group. We provide a comprehensive review of findings from recent studies on the early development of children with autism spectrum disorders, summarizing current knowledge on early signs of autism spectrum disorders, the screening properties of early detection tools, and current best practice for diagnostic assessment of autism spectrum disorders before 2 years of age. We also outline principles of effective intervention for children under the age of 2 with suspected/confirmed autism spectrum disorders. It is hoped that ongoing studies will provide an even stronger foundation for evidence-based diagnostic and intervention approaches for this critically important age group.

The autism spectrum: definitions, assessment and diagnoses.

This article summarizes current research related to autism spectrum disorders. Current epidemiological trends, theories about aetiology, and relevant issues in assessment and diagnosis of autism spectrum disorders are discussed.

Challenges in evaluating psychosocial interventions for Autistic Spectrum Disorders.

In 2002, the National Institutes of Health sponsored a meeting concerning methodological challenges of research in psychosocial interventions in Autism Spectrum Disorders. This paper provides a summary of the presentations and the discussions that occurred during this meeting. Recommendations to federal and private agencies included the need for randomized clinical trials of comprehensive interventions for autism as the highest, but not the sole priority. Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics, standardized documentation and methods of diagnosis, development of outcome measures, establishment of standards in research; and the need for innovative treatment designs, including application of designs from other research areas to the study of interventions in ASD.