Clinical Trials Aim to Determine Best ADHD Treatments

Dr. Mark Stein is leading several ongoing research studies to improve ADHD treatments.
Dr. Mark Stein is leading several ongoing research studies to improve ADHD treatments.

Seattle Children’s Program to Evaluate and Enhance Attention, Regulation and Learning (PEARL) clinic aims to treat children with attention deficit hyperactivity disorder (ADHD) and associated problems using the newest and most effective treatments available. To determine which of those treatments is most appropriate for each patient, Dr. Mark Stein, director of the PEARL Clinic and investigator in Seattle Children’s Research Institute’s Center for Child Health, Behavior and Development, is leading several ongoing research studies that are currently enrolling patients.

Treating mothers first

Stein estimates about 20% of children with ADHD have a parent with the same disorder. Unfortunately, adults with ADHD can be more difficult than children to diagnose because their symptoms are less obvious and ADHD is viewed primarily as a childhood disorder. Parents with ADHD may display excessive forgetfulness and difficulty with time management, organization, and stress intolerance, all of which can impact parenting.

“One of the most common reasons children don’t respond to ADHD treatment is because the parents have ADHD themselves,” Stein said. “If a parent goes untreated, they are more likely to forget their child’s medications, miss appointments, lose behavioral charts or not notice positive behaviors when they occur.”

Stein is leading a research study called “Mother’s First” in collaboration with Andrea Chronis-Tuscano, Ph.D. from University of Maryland, to see if treating mothers with ADHD might delay the onset of ADHD in kids. The study provides a diagnostic evaluation for ADHD and 16 weeks of treatment to mothers using medications and/or parent training sessions. Both mothers and children are assessed throughout the study. Participants include mothers and children who have not yet taken any medications for ADHD.

The role of genetics in medication response

Stein is collaborating with child and adolescent psychiatrist Dr. Carol Rockhill, a clinical psychiatrist and investigator in Seattle Children Research Institute’s Center for Clinical and Translational Research, to conduct a second study which will monitor side effects of ADHD medications and determine if a child’s genetics or other factors might affect their reaction to ADHD medications. In this study, called the Response Impressions and Side Effects Scale (RISK) study, parents report medication side effects, such as sleep problems or poor appetite, and DNA is collected from saliva samples in trial participants.

Study results could be used by clinicians to more safely monitor ADHD medications and better predict adverse affects of medications in children with ADHD.

“It can be very challenging to determine which treatment will work best for a child with ADHD,” Stein said. “This research may provide us with biological indicators so we can prescribe the most effective medications to children earlier.”

Participants will be children between the ages of 4 and 12 years old who have recently begun treatment for ADHD symptoms in outpatient psychiatry or primary care clinics. Patients will be assessed and asked to answer questionnaires about changes in their child’s symptoms during ADHD treatment.

A second clinical trial evaluating medication responses in children with ADHD is The Effects of ADHD Medication (TEAM) Study. For this research, clinicians provide an ADHD evaluation to participants that includes a medical history, physical and school observations. For eligible participants, clinicians determine the optimal medication dose and evaluate the impact of the treatment on each child by observing participants in the classroom, as well as using other measures.

When a child has autism and ADHD

For children with both autism and attention difficulties, Stein is collaborating with Dr. Soo-Jeong Kim, a child psychiatrist and investigator in Seattle Children Research Institute’s Center for Integrative Brain Research, on a study to determine if the FDA approved ADHD medication Quillivant XR could be used to effectively treat children with both conditions.

“Quillivant XR is a commonly prescribed ADHD medication that has been used off-label to treat autism as well,” Stein said. “Still, few studies have tried to treat the symptoms of both ADHD and autism, who may be more sensitive to high stimulant doses or unable to swallow pills. This study will help us determine if this is an effective treatment for the many children who have both conditions.”

Children, ages 5 to 16, will be screened at Seattle Children’s and, if eligible, will receive the medicine Quillivant XR for 6 weeks. The investigators will also collect saliva DNA samples from patients to search for any biomarkers that might indicate specific responses to this treatment.

In you’re interested in learning more or participating ADHD studies, contact Libby Bliss at (206) 884-1488 or [email protected].

Parents of children with ADHD, ages 6 to 11, can also enroll their child in Camp Seastar, a summer treatment program Stein created for children with ADHD. The goal of the treatment program is to promote socialization and self esteem with parent training and sports instruction. For more information contact Libby Bliss at the phone number or email above.