Tailor ADHD treatment to patient, family needs

September 2005

A wide variety of highly effective attention-deficit/hyperactivity disorder (ADHD) medications are currently available, but when selecting treatment for a child with ADHD, physicians should individualize their approach, carefully considering each patient’s history and tailoring the treatment needs to that of the patient and the family, according to David G. Fassler, MD, clinical professor of psychiatry at the University of Vermont in Burlington.

“We now know that as many as half of all children with ADHD continue to have symptoms into adulthood,” he said. “The real advances in ADHD have to do with increased recognition and awareness. As a result, more children, adolescents and adults are getting treatment.”

ADHD affects approximately 3% to 7% of all school-age children nationwide, or approximately two million children, and it is the most commonly diagnosed psychiatric disorder among school-age children. Sixty percent of children with the disorder carry their symptoms into adulthood, according to a release.

Through proper medication and early identification, children living with this neurobiologic disorder can receive proper treatment before secondary problems develop that could last well into adulthood.

Stephen P. Hinshaw, PhD, professor and chair of the department of psychology at the University of California, Berkeley, agreed with Fassler, stating that all treatments need to be individualized and the best chance to improve patient functioning occurs when physicians use multimodal treatment (medication plus behavioral interventions) and the family reduces their negative and/or ineffective discipline style as they receive treatments.

“The only two empirically supported treatments for ADHD are medications and behavior modification treatments,” said Hinshaw, an ADHD researcher. “When you combine these, you have the best chance of getting behavior not just improved but normalized.

“On average, combining treatments yields a greater chance of attaining normal ranges of behavioral and academic functioning and may allow a somewhat lower dosage of medication than if medication is used as the sole treatment,” he told Infectious Diseases in Children.

Identifying ADHD

Diagnosis occurs when a child demonstrates six or more of nine specific symptoms of inattention and impulsivity/hyperactivity on a continuing basis for more than six months in more than two settings. ADHD symptoms among children can include trouble paying attention, listening, following instructions and finishing work. Fassler also highlighted other signs, such as being easily distracted, frequent loss of items, careless mistakes, fidgeting or constant squirming and forgetting to do simple things like turning in homework.

However, it is important to keep in mind that some of these behavioral symptoms may occur in children without ADHD and may not be an absolute indicator of ADHD; therefore, diagnosis should only be done after a thorough evaluation. To distinguish normal child-like behaviors from ADHD symptoms, realize that ADHD symptoms must occur frequently, at home and at school, and interfere with the child’s ability to function normally.

“What we’re looking for is a cluster of symptoms that lastingly persists and interferes with the child’s ability to function, either at home, in school or with their friends,” he said.

The process of diagnosing ADHD requires several steps and involves gathering information from multiple sources about the child’s behaviors.

There are three main types of ADHD in children.

The first, and most common form of ADHD, is the combined type. Children with this type of ADHD show all three symptoms of inattentivity, hyperactivity and impulsiveness. The second type of ADHD is the hyperactive/impulsive type, in which children demonstrate these two behaviors, but are still able to pay attention. The last type of ADHD is the inattentive type, formerly known as attention-deficit disorder without hyperactivity(ADD). Children with this type of ADHD often go unrecognized as having ADHD because they are not overly active and their symptoms are more subdued.

Stimulant medications

Psychostimulants are a highly effective treatment for childhood ADHD. These medicines help children to focus their thoughts and ignore distractions. Stimulant medications are effective in 70% to 80% of patients, even more if a systematic trial of a second stimulant is done after a first one does not seem to work well.

Stimulants work with the frontal cortex of the brain to block the re-uptake of two neurotransmitters: the dopamine and norepinephrine systems. There is a relative balance of these two, and in children with ADHD, the balance is somehow altered, explained Melvin D. Oatis, MD, assistant professor of clinical psychiatry at the New York University Child Study Center.

Physicians use stimulants to treat both moderate and severe ADHD, and the FDA approved them for use in adolescents and children older than age 6 who are having difficulty with ADHD symptoms.

Stimulants are the real mainstay of ADHD treatment; they have been used for a long time and have a reputation of being safe and effective, according to Oatis.

“But sometimes some children have comorbidities with depression, anxiety and combined medication and behavior interventions helps as well as paying close attention to the patients,” he advised.

The two main classes of leading stimulant medications include methylphenidate and amphetamine compounds. Potential adverse events can include headaches, decreased appetite, sleep disturbances, potential height effect, stomachaches, moodiness and an association with tics.

Nonstimulant medications

Other ADHD treatments comprise non-stimulant medications. Stimulant medications work rather quickly, whereas nonstimulants take more time to be effective.

In 2003, the FDA approved the first nonstimulant medication, atomoxetine (Strattera, Eli Lily). Atomoxetine is a long-acting ADHD medication for use in children and adults. It is administered once a day and blocks the transporter of norepinephrine more selectively.

Other nonstimulants, generally used less often than the other agents, according to Oatis, include bupropion, venlafaxine (Effexor, Wyeth), clonidine (Catapres, Boehringer Ingelheim) and guanfacine (Tenex, ESP Pharma).

Potential adverse events can include decreased appetite, stomachaches, mood swings, tiredness, dizziness, nausea and vomiting.

ADHD medications are either long- or short-acting compounds and differ in their mechanism of release and length of time they remain in the bloodstream.

The short-acting formulation stimulants are generally effective for three to four hours, with individual variability, and require multiple dosing through the day. Long-acting formulations differ in how they are delivered, the time they remain in the bloodstream and can last anywhere from 8 to 12 hours.

Treatment approaches

Because ADHD medicines are available in short-acting, intermediate-acting and long-acting forms. It may take some time to find the best medication, dosage and schedule for the ADHD patient.

Studies show that long-term treatment with a combination of medications and behavioral therapy is superior to just medication treatment, or no specific treatments in managing hyperactivity, impulsivity, inattention and symptoms of anxiety and depression.

An authoritative review by William E. Pelham Jr. supports Hinshaw’s notion that the only two empirically supportive treatments for ADHD are medications and behavioral modifications. Unfortunately, Hinshaw said, despite familial appeal, biofeedback treatments have not been submitted to rigorous enough clinical trials, dietary interventions have small effects, one-on-one therapy is not effective for ADHD and other nontraditional interventions are speculative at best.

The two most common adverse events of ADHD medications, which are generally mild, short-lived and occur early in treatment, are appetite suppression and sleep problems, according to Hinshaw. Others range from weight loss to headaches, the jitters, social withdrawal and stomachaches.

Behavioral intervention

Behavioral treatment serves as a viable alternative for those parents who do not want their child on particular medications or for those patients who cannot tolerate a particular treatment. Therefore, an alternative treatment is needed.

While there are a lot of other nonmedication alternatives that research has evaluated, such as dietary treatment, chiropractic treatment, play therapy and relaxation treatments, none of them have been shown to be effective in rigorous empirical tests, Hinshaw said.

However, behavioral interventions are known to work. These interventions involve adjusting the environment to promote more successful social interactions. Such adjustments include creating more structure, encouraging routines and clearly stating expectations of the child with ADHD.

The most common behavioral procedure available is the clinical behavior therapy, in which a therapist works as a consultant to the parents and teachers to assist in educating them on how to change their environment to improve behavior and enhance learning in the child.

“We work with the parents to teach them how to use rewards and punishment contingencies consistently and effectively to change the learning environment at home and at school,” Hinshaw said. “We help the parent find rewards that will motivate their child to work and help them create a more regular, consistent environment.”

It is important to let patients choose their own reward system and change the rewards often, so they do not lose attention span and bore easily.

Clinical behavior therapy incorporates ADHD education, advises external structuring, devises a daily report card system, provides therapy and counseling and improves organizations skills between the home life and school atmosphere.

Research has shown that “if you implement these programs you can reduce the symptoms of ADHD and enhance the academic performance of the child,” Hinshaw said.

Cognitive behavioral therapy is another behavioral intervention that consists of self-control through self-instruction, problem solving and self-monitoring, evaluation and reinforcement. For this intervention, the therapist works directly with the child to try to help him self-manage his behavior. It is not as effective as behavioral therapy, but it could help to extend the benefits of reward programs over time.

Preliminary findings, presented at the American Occupational Therapy Association’s 85th Annual Conference and Expo, from an ongoing study of ADHD children show that occupational therapy using sensory intervention can significantly improve problem behaviors, such as restlessness, impulsivity and hyperactivity.

All of the study participants, from the OT4Kids occupational therapy center in Crystal River, Fla., were taking medication for ADHD. Of the 88, 63 children underwent 40 one-hour sensory intervention therapy sessions, while 25 did not.

Of the 63 study participants receiving occupational therapy, 95% improved. This is the first study of this size to evaluate sensory intervention for ADHD.

Temple University researchers, Kristie Koenig, PhD, and Moya Kinnealey, PhD, wanted to determine whether ADHD problem behaviors would decrease if underlying sensory and neurological issues were addressed with occupational therapy.

Sensory intervention

“Many children with ADHD also suffer from sensory processing disorder, a neurological underpinning that contributes to their ability to pay attention or focus,” explained Koenig. “They either withdraw from or seek out sensory stimulation like movement, sound, light and touch. This translates into troublesome behaviors at school and home.”

Therapy techniques appeal to the three basic sensory systems: The tactile system controls the sense of touch, the vestibular system controls sensations of gravity and movement and the proprioceptive system regulates the awareness of the body in space. Therapy is tailored to each child’s needs.

“We found significant improvement in sensory avoiding behaviors, tactile sensitivity and visual auditory sensitivity in the group that received treatment,” said Koenig. The researchers found that within six months patients who participated in occupational therapy using sensory-based interventions had significant reductions in changes of ADHD behaviors.

However, Fassler noted caveats with this study. He said the sample size was small and it was not a double-blinded study, which makes it difficult to draw conclusion when there are more rigorous studies that examine the same topic.

Advances in ADHD

This past May, the FDA approved dexmethylphenidate HCl (Focalin XR, Celgene Corp. and Novartis Pharma) extended-release capsules for the treatment of ADHD in adults, adolescents and children. FDA officials approved the drug based on efficacy and safety data from clinical trials, which involved approximately 320 adults, adolescents and children diagnosed with ADHD.

“Focalin XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose that lasts throughout the entire school or work day,” said Thomas Spencer, MD, associate professor of psychiatry, Harvard Medical School, and assistant director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital.

A pivotal clinical trial of 6- to 17-year-old children and adolescents demonstrated the efficacy and tolerability of dexmethylphenidate HCl for the treatment of ADHD in this age group. In this trial, 103 ADHD patients received a flexible dose of dexmethylphenidate HCl or placebo once daily for seven weeks.

Results indicated that dexmethylphenidate HCl was statistically superior to placebo, based on the Conners’ ADHD/DSM-IV Scales for Teachers – a tool used in clinical trials to assess attention and behavior. Dexmethylphenidate HCl was generally well tolerated and the most frequently reported adverse events included decreased appetite, headache, dyspepsia, upset stomach, abdominal pain and anxiety.

In June, the FDA expanded the indications for once-daily treatment of Adderall XR (Shire Pharma), confirming its safety and efficacy in adolescents. The FDA expanded the drug’s indications to include 13- to 17-year-old teenagers diagnosed with ADHD.

Since October 2001, Adderall XR has been approved for treatment in children 6 to 12 years old and since August 2004 in adults 18 and older.

“There has long been an unmet need for ADHD research and treatment among the adolescent population despite an increasing awareness of ADHD’s potential impact on quality of life. Therefore, approval of an ADHD treatment for this under identified age group is an important milestone,” explained Timothy E. Wilens, MD, of Massachusetts General Hospital.

The FDA based its approval on data supplemental to the drug’s New Drug Application. These data included the results of a pharmacokinetic study and a placebo-controlled, fixed-dose clinical trial of a range of doses of once-daily Adderall XR in adolescents with ADHD.

The study showed Adderall XR at doses between 10 mg and 40 mg daily were statistically and significantly superior to placebo. Study results indicated that 63% of investigators considered participants’ symptoms to be improved or very much improved compared with 27% of investigators whose patients received placebo.

Communication is key

It is important physicians and pediatricians communicate with the family when treating ADHD pediatric patients, Hinshaw advised.

“Realize that ADHD can exist comorbidly with other disorders that require additional treatments,” he said.

The more frequent the check-ups are, the more they appear to help, according to Hinshaw, especially during the early phases of treatment. Monitor the patient’s progress through a collection of parent and teacher rating scales and evaluate the patient and the family’s motivation for treatment.

Helping to improve parents’ organization skills, time management skills and anger control is important as well, he advised, because many times parents of children with ADHD may have similar symptoms themselves. Physicians should be aware of parent training, school consultation, social skills work and other psychosocial interventions. Hinshaw recommends knowing a psychologist in the area to whom you can refer families.

Hinshaw recommends physicians review ADHD treatment guidelines published by both the American Academy of Child and Adolescent Psychiatry and the AAP to determine the best treatment approach for each patient.

“Both guidelines are extensive, focusing on a multimodal treatment approach that includes judicious trials of medication, supplemented by behavioral treatment, parent education, school accommodations, etc,” he said.

For more information:

• Presented at the American Medical Association media briefing. Sept. 9, 2004. New York.
• Visit www.fda.gov.
• Koenig K, Kinnealey M. Comparative outcomes of children with ADHD: treatment versus delayed treatment control condition. Presented at the American Occupational Therapy Association’s 85th Annual Conference and Expo. May 12-15, 2005. Long Beach, Calif.
• McGough JJ, Biederman J, Wigal SB, et al. Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2005;44(6):530-538.
• New Drug Application - N021802. Focalin XR Dexmethylphenidate Hydrochloride. May 26, 2005.
• Pelham WE Jr, Wheeler T, Chronis A. Empirically supported psychosocial treatments for attention deficit hyperactivity disorder. J Clin Child Psychol. 2005;27(2):190-205.
• Weisler, RH. Safety, efficacy and extended duration of action of mixed amphetamine salts extended-release capsules for the treatment of ADHD. Expert Opin Pharmacother. 2005;6(6):1003-1018.
• Grcevich, S. Safety and efficacy of MAS XR in adolescents with ADHD. Poster 314a/b. Presented at the annual meeting of the American Academy of Child and Adolescent Psychiatry. October 19-24, 2004. Washington. To be published in October’s issue of Clin Ther.