UNC autism study seeking participants
Parents of children with autism are being sought to participate in a research study being conducted by the University of North Carolina School of Medicine.
The study, part of a global research program, will evaluate the effects of a new drug on social interaction and communication of children ages 6 to 12 years who are affected by autism, Asperger’s or pervasive developmental disorders not otherwise specified.
Dr. Linmarie Sikich, who heads the UNC research team, said, “At present there are no medicine treatments that help autism spectrum disorders.”
The research, which is being conducted at 180 study centers around the world, will investigate the effectiveness of memantine on behaviors associated with the disorders.
“Autistic children often have unusual characteristics related to language, trouble starting conversations, trouble with the back-and-forth of conversation,” Sikich said.
Other characteristics are shifting attention, repetitive behavior and intense interests.
The research team is enrolling children to participate in the study.
Sikich said, “They have a chance to try a medicine we have reason to believe from earlier research will help them.”
She said a parent can enroll a child or obtain more information by calling (800) 708-0048 or by email at firstname.lastname@example.org. An overview of the program is available online at connectmetrial.com.
“The first part is a careful diagnostic examination to be sure it’s autism and not something else,” Sikich said.
Children whose behavior stems from something other than autism will not be accepted for the study, but the team can point the parent toward appropriate resources.
The study is divided into three phases.
“The first phase lasts three to 12 months and involves seven to 10 visits,” Sikich said. “Everybody gets the medicine in this phase. If a child doesn’t change for the better, their participation will end. The drug isn’t benefiting them.”
The second phase, which lasts 12 weeks and involves six visits, is the experimental phase. Some children will continue to take the medicine and some will get a sugar pill.
“This allows us to see if somebody gets better, do they still need the medicine,” Sikich said.
In the third phase, which includes 10 visits over a period of 12 months, all the children will again receive the medicine.
The researchers hope to answer questions such as:
• Does the medicine help?
• Do the benefits continue after the child is no longer taking it?
In addition to the hoped-for improvements in their child’s behavior, parents can benefit from participating in the study.
“They’ll be able to talk with somebody who knows about autism,” Sikich said.
The staff can answer questions related to talking with school administrators and how to talk with officials at the child’s school.
“We provide a lot of information about autism,” Sikich said. “We have a lending library with brochures and other printed material. We can link them up with resources in the community.”
Each child’s health will be carefully monitored by experienced physicians throughout the study.
There is no cost to the participating families for any of the services or information.
To help with travel expenses, the team will pay participants $50 for each visit.
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