Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder

Anagnostou, Evdokia; Jones, Nicholas E.; Huerta, Marisela; Halladay, Alycia; Wang, Paul; Scahill, Lawrence David; Horrigan, Joseph P.; Kasari, Connie; Lord, Cathy; Choi, Dennis C.; Sullivan, Katherine; Dawson, Geraldine

doi:10.1177/1362361314542955

Cited by 184 publications

(159 citation statements)

References 127 publications

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“…At the time that the study was designed, there was a lack of validated measures of the core problems of social affect and communication experienced by children with ASD that were sensitive to change. 35,36 The ADOS was originally developed as a diagnostic tool to assess whether or not children have impairments and unusual behaviours that would indicate ASD. Although some previous studies have used the ADOS to assess the clinical effectiveness of interventions, 22,37,38 concerns have been raised about the suitability of the ADOS to assess changes in the adaptive functioning of children with ASD.…”

Section: Strengths and Weaknesses Of The Study Designmentioning

confidence: 99%

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study

Crawford

Gold

Odell‐Miller

et al. 2017

Health Technol Assess

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Background Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). Objectives To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. Design International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Setting Schools and private, voluntary and state-funded health-care services. Participants Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. Interventions All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. Main outcome measures The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). Results A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS social affect decreased from 14.1 to 13.3 in music therapy and from 13.5 to 12.4 in standard care [mean difference: music therapy vs. standard care = 0.06, 95% confidence interval (CI) –0.70 to 0.81], with no significant difference in improvement. There were also no differences in the parent-rated social responsiveness score, which decreased from 96.0 to 89.2 in the music therapy group and from 96.1 to 93.3 in the standard care group over this period (mean difference: music therapy vs. standard care = –3.32, 95% CI –7.56 to 0.91). There were seven admissions to hospital that were unrelated to the study interventions in the two IMT arms compared with 10 unrelated admissions in the ESC group. Conclusions Adding IMT to the treatment received by children with ASD did not improve social affect or parent-assessed social responsiveness. Future work Other methods for delivering music-focused interventions for children with ASD should be explored. Trial registration Current Controlled Trials ISRCTN78923965. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 59. See the NIHR Journals Library website for further project information.

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Section: Strengths and Weaknesses Of The Study Designmentioning

confidence: 99%

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study

Crawford

Gold

Odell‐Miller

et al. 2017

Health Technol Assess

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“…All of these tools are designed to measure change in response to treatment in ASD. Both CGI and ABC are documented to be sensitive to change (Anagnostou et al, 2015). Review of the outcome measures is documented in Table 3: Summary of Study Measures.…”

Section: Resultsmentioning

confidence: 99%

“…A number of widely used validated outcome measures were used, including the CGI (Guy, 1976), the Social Responsiveness Scale (Constantino, 2002), the ADOS (Autism Diagnostic Observation Schedule; Lord et al, 2000), as well as several cognitive measures. The Social Responsiveness Scale and the ADOS are not tools designed to measure treatment response in ASD and their ability to detect change remains unclear (Anagnostou et al, 2015). Treatment and control groups were receiving ABA therapy during the study.…”

Section: Resultsmentioning

confidence: 99%

Hyperbaric oxygen therapy for the treatment of children and youth with Autism Spectrum Disorders: An evidence-based systematic review

Goldfarb

Genore

Hunt

et al. 2016

Research in Autism Spectrum Disorders

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“…In other areas, such as ASD or rare phenocopy syndromes, where there are fewer treatment studies with significant findings (or none), it is more difficult to identify a narrow set of outcome measures that will reliably detect change in symptoms. In such cases, the field must start by identifying consensus measures, which are likely to be imperfect, while waiting for more data to emerge (Anagnostou et al, 2014 (in press); Scahill et al, 2013). Studies that choose a less commonly used primary outcome measure should still include 1-2 standard measures to allow cross-measure comparison.…”

Section: Measurement Challenges: Differentiating Treatment Effects Frmentioning

confidence: 99%

Intervention in the Context of Development: Pathways Toward New Treatments

Veenstra‐VanderWeele

Warren

2014

Neuropsychopharmacol

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Neuropsychiatric disorders vary substantially in age of onset but are best understood within the context of neurodevelopment. Here, we review opportunities for intervention at critical points in developmental trajectories. We begin by discussing potential opportunities to prevent neuropsychiatric disorders. Once symptoms begin to emerge, a number of interventions have been studied either before a diagnosis can be made or shortly after diagnosis. Although some of these interventions are helpful, few are based upon an understanding of pathophysiology, and most ameliorate rather than resolve symptoms. As such, in the next portion of the review, we turn our discussion to genetic syndromes that are rare phenocopies of common diagnoses such as autism spectrum disorder or schizophrenia. Cellular or animal models of these syndromes point to specific regulatory or signaling pathways. As examples, findings from the mouse models of Fragile X and Rett syndromes point to potential treatments now being tested in randomized clinical trials. Paralleling oncology, we can hope that our treatments will move from nonspecific, like chemotherapies thrown at a wide range of tumor types, to specific, like the protein kinase inhibitors that target molecularly defined tumors. Some of these targeted treatments later show benefit for a broader, yet specific, array of cancers. We can hope that medications developed within rare neurodevelopmental syndromes will similarly help subgroups of patients with disruptions in overlapping signaling pathways. The insights gleaned from treatment development in rare phenocopy syndromes may also teach us how to test treatments based upon emerging common genetic or environmental risk factors.

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Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder

Cited by 184 publications

References 127 publications

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study

International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study

Hyperbaric oxygen therapy for the treatment of children and youth with Autism Spectrum Disorders: An evidence-based systematic review

Intervention in the Context of Development: Pathways Toward New Treatments

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