Improvisational music therapy did not significantly reduce symptom severity in children with autism spectrum disorder (ASD) in comparison with enhanced standard care, results of a large randomized trial have shown.
Despite the negative outcome, this new study should not signal the end of music therapy for patients with autism, study author Christian Gold, PhD, principal researcher, Uni Research, and Grieg Academy Music Therapy Research Center, Bergen, Norway, told Medscape Medical News.
“I think it is perhaps the end of some claims about the effect of music therapy as it is practiced today, but it could be the beginning of a new era of evidence-based music therapy practice and research,” Dr Gold said.
The study was published online August 8 in JAMA.
The Trial of Improvisational Music Therapy’s Effectiveness for Children With Autism (TIME-A) included 364 children with ASD. The children were aged 4 years to younger than 7 years and were enrolled from centers in nine countries.
Most of these children were boys (83%) and had been diagnosed with childhood autism (83%); the rest had atypical autism, Asperger syndrome, or pervasive developmental disorder. About 45% had low cognitive level (IQ less than 70).
Children were excluded if they had received music therapy in the past year or had a serious sensory disorder.
Of the total, 182 were randomly assigned to received enhanced standard care (usual care plus parent counseling); 182 other patients were randomly assigned to receive enhanced standard care plus music therapy. In the intervention group, 90 received high-intensity music therapy (three times a week), and 92 received low-intensity music therapy (once a week).
Improvisation Techniques
The music therapy consisted of 30-minute one-to-one sessions conducted by qualified music therapists. The therapy was conducted in accordance with consensus principles developed for the study. Sessions included singing or instrumental play and used improvisation techniques such as synchronization, mirroring, or “grounding,” in which an accompanying pianist helped “ground” a singer, explained Dr Gold. Sessions were videotaped or audiotaped.
Standard care often included speech and language therapy, communication training, and/or sensory-motor therapy, such as occupational therapy and physiotherapy.
The primary outcome was the social affect score of the Autism Diagnostic Observation Schedule (ADOS). Constructed as the sum of the relevant items for the social affect domain, the ADOS social affect score can range from 0 to 27, with higher scores indicating greater severity. Researchers assumed a minimal clinically important difference (MCID) of 1 point.
Assessors of the primary outcome were blinded to group allocation; however, blinding was broken in 20 cases, most often because a parent or another person inadvertently mentioned the intervention.
Rather than being an “explanatory” trial, Dr Gold described it as “pragmatic,” because it focused on generalizability and because of the way in which therapies, study participants, participating centers, and outcomes were chosen.
Pragmatic Trial
“A pragmatic trial is designed with generalizability in mind, whereas an explanatory trial is planned to maximize the chances of finding an effect,” Dr Gold said.
Although the formal criterion for early stopping was not met, the study team opted to cease recruiting after the 364 participants were enrolled, partly because of limited funding. The original plan was to recruit up to 1000 participants.
At 5 months, mean scores of ADOS social affect decreased from 14.08 to 13.23 in the music therapy group and from 13.49 to 12.58 in the standard care group (mean difference, 0.06; 95% confidence interval, -0.70 to 0.81; P = .88).
It was probably by chance that the mean baseline ADOS social affect score was somewhat lower in the enhanced standard care group than in the music therapy group, said Dr Gold.
That the amount of improvement in both groups was small and was less than the MCID suggests that music therapy for children with ASD may not lead to meaningful improvement in symptom severity, commented Dr Gold.
Differences were nonsignificant in models adjusted for site and differed only slightly in linear mixed-effects models that used data from all time points at once. There were also no significant differences between high-intensity or low-intensity music therapy compared to standard care.
No Definitive Evidence
There were a few significant secondary outcomes – for example, improvements in scores on social responsiveness subscales – but these were small and were “unlikely to be clinically important,” the authors write.
Those results “don’t provide definite evidence,” added Dr Gold.
“The question is, what should be the aim of music therapy?” he said. “In this study, we thought it should be autism severity, and people have claimed for many decades that it should be about autism severity. We showed that music therapy does not change that. It does not say that music therapy could not be good for other things, like helping to integrate children in their social environment.”
Because very early intervention may be important for children with autism, would introducing music therapy before age 4 years have made a difference? “We can only speculate,” said Dr Gold.
But he acknowledged that starting the intervention at a very early age may have some benefits, as could continuing the therapy for longer than 5 months.
The new findings differ from those of some previous studies, including a Cochrane Collaboration meta-analysis. But previous trials were shorter and were limited to one center and one or just a few therapists.
“This new study provides more rigorous evidence than past research,” said Dr Gold. “This was the first time that something was done across several centers, with different music therapists who had different training backgrounds and in different healthcare settings.”
The burden associated with attending music therapy sessions needs to be considered, however, said Dr Gold. In this study, those in the music therapy group tended to receive fewer therapies of other kinds, and some parents found it difficult to take their child to all planned sessions.
The researchers have carried out post hoc analyses that uncovered some “interesting” findings, said Dr Gold.
“We have some indication that music therapy might work better for boys, and we also have some indication that it might work better for those with low-functioning autism,” in which children do not speak and have lower cognitive function.
Interventions for autism are typically targeted at high-functioning patients, said Dr Gold.
People should not “just assume” that music therapy, or any therapy, is effective in children with autism, said Dr Gold. There should be rigorous evidence for it from research, as is common in other medical conditions.
Music therapy will need to be developed further in order to better target those most likely to benefit from it, said Dr Gold.
Large and Robust
Arshya Vahabzadeh, MD, innovation officer, Massachusetts General Hospital, and chief medical officer, Brain Power, a neurotechnology company that has developed artificially intelligent smart glasses for people with autism, commented on the findings for Medscape Medical News.
Dr Vahabzadeh praised the study for its large size and for being “robust” and “methodologically sound.” He also noted that it included children in a relatively narrow age range and had very few exclusion criteria.
These elements, he said, make it “a little more pragmatic and realistic” than previous research in reflecting the community.
The disadvantage, however, is that having such broad inclusion criteria creates a very heterogeneous sample, said Dr Vahabzadeh.
“Within that group are children who benefit and children who don’t benefit just because of that diversity,” he said. “But by kind of clumping them all together, you may not as easily be able to find the signal in the noise.”
Outcomes other than the primary one used in the study might be more meaningful to children with autism and their parents by, for example, reducing family stress, enhancing adaptive skills, improving sleep, or creating a more soothing environment, said Dr Vahabzadeh.
And, he stressed, the results “very clearly don’t mean that kids with autism don’t like music. Many do.”
In an accompanying editorial, Sarabeth Broder-Fingert, MD, MPH, Department of Pediatrics, Boston University School of Medicine, and colleagues also described the new study as “well designed” and “carefully executed.”
They said it addressed a number of limitations of the previous Cochrane review; in addition to enrolling a large number of participants and using a narrow age range for inclusion, it tested a single form of music therapy and monitored intervention fidelity.
However, they point out that few children were ineligible for the study and that children of any intelligence level were included, as were those with comorbid conditions.
“Therefore, study participants represented many different languages, musical traditions, cultural expectations around child development, and cognitive abilities, and they likely were embedded in communities with variability in available ASD services,” the editorialist write.
As with Dr Vahabzadeh, they noted that because of the approach used in the study, results may be averaged over a heterogeneous population of possible responders and nonresponders, “thereby reducing investigators’ ability to show differences in aggregate.”
The editorial writers also commented, as did the study authors, that participants who received music therapy attended fewer non–music therapy interventions than did the control group (36 vs 45 sessions).
Music therapy, they said, “is designed to supplement – not substitute for – standard ASD treatment.”
Given the strong theoretical basis for music therapy and empirical support for it from multiple small studies, an explanatory approach – rather than a pragmatic approach, such as the one used in the study – might be an equally valid way to ascertain the potential effects of music therapy under more tightly controlled circumstances, write Dr Broder-Fingert and colleagues.
They conclude that it “seems premature” to definitively conclude that the new findings mark the end of improvisational music therapy as a potential intervention for children with ASD.
Dr Gold and the editorialists have disclosed no relevant financial relationships. Dr Vahabzadeh is the chief medical officer of Brain Power and is on the board of advisors of the Special Needs Network, Los Angeles.
JAMA. Published online August 8, 2017. Abstract, Editorial
Tidak ada komentar:
Posting Komentar