Clouds of Uncertainty Testing ‘Preemptive’ Therapy to Alleviate Traits of Autism | Spectrum

First days: Researchers say preventive autism intervention has big benefits, but some question the data.

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This week’s headlines praised a behavioral therapy parents can offer their babies to reduce the intensity of children’s autistic traits and lower their chances of being diagnosed by age 3, but independent experts are calling for it. Caution: The observed effects were small and the study’s analysis raises questions as to whether its findings will resist replication.

“Even with less than optimal statistical analyzes and poorer than ideal results, this is important, relevant and timely work,” says April Benasich, professor of cognitive developmental neuroscience at the University. Rutgers from Newark, New Jersey, who were not involved in the research.

The study follows a 2019 single-blind randomized controlled trial of 103 babies who showed behavioral signs of autism at 9 to 14 months of age. Six months later, the babies who had received the experimental therapy did not behave differently from controls on a measure of autism traits.

In the new work, the same team followed 89 of the children up to the age of 3. By that time, 12 had been diagnosed with autism, and those in the control group, who had not received the experimental therapy, were three times more likely than those who had to meet diagnostic criteria for the disease, according to study. The work appeared on Monday in JAMA Pediatrics.

“Although these effects were of a fairly small magnitude, with uncertain clinical significance,” says Benasich, “it is still worth doing and, most importantly, teaches parents valuable skills for communicating with their children. “

Guiding interactions:

The children in the study all tested positive for signs of autism on the revised Social Attention and Communication Monitoring measure at 9 to 14 months of age. The tool is more accurate when given multiple times, but many children only take it once before being referred or not to a specialist, says lead researcher Andrew Whitehouse, professor of research on the autism at the Telethon Kids Institute in Western Australia.

Parents of 50 babies learned to administer experimental therapy, called iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP). In 10 bi-weekly sessions, parents watched videos of their own interactions with their child, while a trained therapist offered them communication tips. Parents practiced their skills with their children for at least 15 minutes a day during the initial five-month study period. The parents of 53 other children received no training, but some received other therapy elsewhere.

The new work reassessed autism traits in 44 children in the control group and 45 children in the treatment group at ages 2 and 3, using the Autism Diagnostic Observation Program (ADOS). Clinicians also assessed children for autism at age 3.

Those whose parents had received training had less pronounced autistic traits than controls, measured over a period of 12 months to 3 years. And three children in the treatment group were diagnosed with autism, compared to nine controls.

“Children who fell below the diagnostic threshold still had developmental difficulties,” Whitehouse says. “However, this study showed that by working with each child’s unique differences, rather than trying to counter them, iBASIS-VIPP therapy effectively supported their development throughout early childhood.”

The results are consistent with studies of the same therapy in younger siblings of children with autism – the so-called “little siblings,” who are about 20 times more likely to have autism than the general population. After their parents were trained using iBASIS-VIPP, baby siblings showed a significant reduction in autism traits by age 3, as measured by ADOS or l ‘Autism Observation Scale for Infants, according to a 2017 study.

EthicsAl problems:

The primary outcome of the study, differences in trait severity, was statistically significant on a one-sided test, which only examines whether a treatment is more effective than the control condition. But choosing a one-sided test over a more stringent two-sided test – which explains the possibility that one treatment might be more or less effective than usual treatment – increased the chances that the results would be statistically significant, says Benasich.

“This analytical choice rules out the possibility of exploring an effect in the other direction and, given the poor statistical results at the unilateral level, it is likely that the bilateral results do not reach or reach significance,” explains Benasich.

Autism diagnoses at age 3, the secondary outcome of the study, reached conventional statistical significance levels for two-tailed testing, although a prerecorded plan to conduct the study called for unilateral testing, Whitehouse said.

The small number of participants also lowers confidence in the results, says Regina Nuzzo, senior statistical communications advisor at the American Statistical Association, who was not involved in the study.

Statistics notwithstanding, the survey presents a “very rare” example of a research team doing everything in their power to assess early intervention in autism with minimal risk of bias, says Kristen Bottema-Beutel, associate professor Education, Curriculum and Society at Boston College. in Massachusetts, which did not participate in the work.

“They ticked all the boxes that researchers never tick,” she says. For example, the team pre-recorded their assumptions and detailed how they randomized the groups.

But the premise of the study – what Bottema-Beutel calls a preventive intervention to prevent people from becoming autistic – raises ethical concerns, she says. “Many autistic traits are just differences, they aren’t necessarily something that will make it harder for you to reach developmental milestones.”

The team is sensitive to this concern, Whitehouse says. “Our goal of supporting parent-child interactions is to support and enrich the social environment around the baby – creating learning opportunities for the baby that are tailored to the child’s unique abilities. “

He and his colleagues plan to continue to follow the children to see if the effects detected in the study persist.

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