Autism study conducted entirely online

This article discusses a clinical trial for autism that was done completely online.

UC San Francisco researchers have completed the first Internet-based clinical trial for children with autism, establishing it as a viable and cost effective method of conducting high-quality and rapid clinical trials in this population.

In their study, published in the June 2014 issue of the Journal of the American Academy of Child and Adolescent Psychiatry, the researchers looked at whether an Internet-based trial was a feasible way to evaluate whether omega-3 fatty acids helped reduce hyperactivity in children with autism. The authors found that not only was it a valuable platform for conducting the randomized clinical trial, but that it was both cost and time effective, as well.

"Recruitment for clinical trials in children with autism is one of the biggest challenges we face in studying potential treatments, and we found that process to be accelerated and streamlined by using existing online communities for enrollment," said lead author Stephen Bent, associate professor of medicine at UCSF. "This trial can serve as a model for how to efficiently test potential treatments through the growing power of online communities."

Using the Interactive Autism Network's (IAN) robust online community of parents, the researchers enrolled 57 children from 28 states into the randomized trial.

The enrolled children were randomly assigned to either receive 1.3 grams of omega-3 fatty acids or an identical placebo daily for six weeks. Once a week the participants' parents received an email asking them to complete outcome measures on how their child was doing and report on the child's level of hyperactivity. The children's teachers reported on changes in hyperactivity as well. The parent and teacher responses were submitted to a database, allowing the researchers to access the data immediately.

Because the IAN requires that parents complete a short questionnaire and verify that their child has been professionally diagnosed in order to participate in the online network, the researchers were able to confirm the participants met the diagnostic criteria for autism without a clinic visit.

While the researchers found that the omega-3 fatty acids did not lead to a statistically significant reduction in hyperactivity, they concluded the online trial was a promising technique for evaluating treatments for autism.

"The entire study was completed in slightly more than three months from the start of enrollment, and demonstrates there are many advantages including low cost, rapid enrollment, high completion rate, convenience for participating families, and the ability to participate from virtually any location," said Bent. "We had 100 percent completion of all outcome measures from parents and teachers, indicating that there is an ease to this method of testing that engages parents at a higher rate than traditional trials."

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Study finds treatment very effective for children with high functioning autism

A clinical trial found that children with high-functioning autism can have the symptoms effectively alleviated by intensive treatment.

In a second randomized clinical trial, researchers at the Institute for Autism Research at Canisius College have found a comprehensive summer treatment (summer Max) to be highly effective for children with high-functioning autism spectrum disorders (HFASDs). Children with the disorders endure lifelong impairments involving social and social-communicative functioning and restricted and repetitive interests and behaviors. Despite their significant needs, few comprehensive programs have been developed and validated for children with HFASDs.

Results of this randomized clinical trial found the comprehensive summer treatment to be effective in improving the social performance and clinical symptoms of children with HFASDs. According to Marcus L. Thomeer, PhD and Christopher Lopata, PsyD, the study's lead authors, the findings, which appeared in the journal, Psychology in the Schools (December 2012), supports and extends the findings of a previous randomized trial that initially demonstrated the efficacy of the manualized treatment.

Following the 5-week program, children in the treatment group demonstrated significantly higher scores on child measures of non-literal language skills and knowledge of appropriate social behaviors, as well as significantly higher parent-ratings for targeted and broader social skills and significantly lower ratings of autism symptoms compared to children in the control group. Secondary staff ratings corroborated the significant gains reported by parents. A follow-up assessment 2-3 months post-treatment for the treatment group indicated that the significant gains in social functioning were maintained, and a positive trend suggested that the reduction in autism symptoms continued.

According to Thomeer, "the increase in child understanding along with the increase in parent ratings of social and social-communication skills suggests that the children in treatment acquired new skills and social-cognitive understanding and translated those into effective social performance outside the treatment setting. This is an important finding as generalization of skills and behaviors beyond the treatment setting are a major obstacle for children with HFASDs." The significant decrease in autism symptoms following treatment is also noteworthy as few treatments have been able to reduce these long-term impediments to daily functioning.

One improvement over the previous trial was the addition of follow-up measures in the current study. "The follow-up measures allowed us to determine that the positive treatment effects on social performance continued to be present 2-3 months after the treatment ended," said Lopata. "Although not as robust as the social gains, the children in the treatment group also continued to show reduced autism symptoms." Results of these two randomized clinical trials provide strong evidence of the effectiveness of this unique comprehensive summer treatment for children with HFASDs. Thomeer noted that "this is the first comprehensive treatment specifically for children with HFASDs to be found effective in two randomized trials."

A total of 35 children, ages 7-12 years participated, with 17 randomly assigned to receive the treatment and 18 to a wait-list control condition. Children in the treatment were in groups of six children and three clinical staff. The treatment was conducted five days per week over five weeks and targeted clinical and associated features of autism spectrum disorders including social skills, non-literal language skills, emotion recognition skills, and interest expansion.

Treatment was provided during five, 70-minute treatment cycles each day using direct instruction, modeling, role-playing, and performance feedback. Each treatment cycle consisted of 20-minutes of skills instruction followed by a 50-minute therapeutic activity designed to practice and reinforce target skills. A point system was used to reinforce positive social behaviors and reduce autism symptoms and negative behaviors across the treatment day. Weekly parent education was also provided.

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