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Controlled Clinical Trial Results

April 1, 2007

The gap between results from controlled trials and results in the real world, from the Harvard Mental Health Letter

BOSTON — Will the treatment work in the real world? That’s the issue often raised by the favorable outcome of a formal clinical trial, reports the April 2007 issue of the Harvard Mental Health Letter. It’s so important that special terminology has been developed for it: “the gap between efficacy and effectiveness”—efficacy meaning proof in a carefully controlled trial, and effectiveness meaning success in the circumstances of everyday life.

A new study of a program for delinquent youth shows how great the gap is. When the program was conducted in an ordinary school environment, without close monitoring and specially trained professionals, it not only failed to replicate earlier successes but even made things worse in some ways.

Reconnecting Youth is a program for potential dropouts and other troubled high schoolers aimed at improving school attendance, performance, self-esteem, and drug avoidance. In controlled trials, the program reduced truancy and drug abuse, raised grades, and enhanced self-esteem. However, a new study of youths who were assigned to Reconnecting Youth classes conducted by regular teachers showed no effect on drug use, delinquency, or self-control. Furthermore, six months later, program participants were making worse choices about companions and weekend activities.

One conclusion is that bringing delinquent youths together in groups often makes their behavior worse. “The main lesson, though,” says Dr. Michael Miller, editor in chief of the Harvard Mental Health Letter, “is that positive results in a study conducted by a program’s developers are not sufficient evidence to make a program into a model that can be routinely applied by others in different circumstances.”

Also in this issue:

  • Dependent personality disorder
  • Violence among children
  • Depression at menopause
  • Verbal abuse and children
  • Schizophrenia and physical illness
  • A doctor discusses: Treatment for hair pulling
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The Harvard Mental Health Letter is a unique resource that covers a wide range of mental health issues and concerns. It presents the latest thinking, treatment options, therapies and debate of interest to both mental health care professionals and the concerned public. Read more

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Harvard Health Publications publishes five monthly newsletters—Harvard Health Letter, Harvard Women's Health Watch, Harvard Men's Health Watch, Harvard Mental Health Letter, and Harvard Heart Letter—as well as more than 50 special health reports and books drawing on the expertise of the 8,000 faculty physicians at Harvard Medical School and its world-famous affiliated hospitals. For more information about Harvard Medical School publications, please visit our Web site, www.health.harvard.edu.

Source: Harvard Health Publications
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