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Nonpharmacological response in hospitalized children with conduct disorder
R P Malone1, J F Luebbert, M A Delaney
1Department of Psychiatry, Medical College of Pennsylvania, Philadelphia, USA.
Insights
Nearly half of hospitalized children with conduct disorder improved with placebo or hospital structure alone. This highlights the need for a placebo baseline period before initiating medication for aggression.
Area of Science:
- Child and Adolescent Psychiatry
- Behavioral Sciences
- Clinical Psychology
Background:
- Limited research exists on the impact of hospitalization and placebo response in pediatric conduct disorder (CD) with severe aggression.
- Children with CD are often immediately prescribed pharmacotherapy upon hospitalization, potentially confounding treatment efficacy assessments.
Purpose of the Study:
- To investigate the effects of hospitalization and placebo administration on aggression in hospitalized children with conduct disorder.
- To examine the response to placebo in pediatric conduct disorder patients before initiating active pharmacotherapy.
Main Methods:
- A 4-week double-blind, placebo-controlled study involving 44 children (ages 9.83-17.14) with conduct disorder and severe aggression.
- A 2-week single-blind placebo lead-in period with 24-hour aggression monitoring using the Overt Aggression Scale.
- Randomization to treatment phase only for subjects meeting specific aggression criteria during the placebo baseline.
Main Results:
- Over half (52.3%) of enrolled subjects met criteria for the treatment period (baseline nonresponders).
- Nearly half (47.7%) did not meet criteria (baseline responders), indicating improvement with inpatient milieu/structure and/or placebo.
- A significant portion of children showed improvement without active medication.
Conclusions:
- Immediate pharmacotherapy initiation upon hospitalization for aggression in conduct disorder may lead to inaccurate attribution of improvement.
- A placebo baseline period is crucial to differentiate treatment effects from milieu effects and avoid unnecessary medication.
- Implementing a placebo phase can reduce the risk of Type II errors in aggression-related pharmacological research.
Objective:
There is a paucity of research regarding the effects of hospitalization and/or the response to placebo in children with conduct disorder who are hospitalized for chronic and severe aggression. However, many children with this problem are hospitalized and immediately begin pharmacotherapy. In this report, the effects of hospitalization and placebo administration were examined.
Method:
Subjects were forty-four children (37 males, 7 females) with conduct disorder, aged 9.83 to 17.14 years, who were hospitalized for chronic and severe aggression. This was a 4-week double-blind and placebo-controlled study with a 2-week single-blind placebo lead-in period. During the 2-week placebo baseline period, aggression was measured on a 24-hour basis, using the Overt Aggression Scale. Only subjects meeting a specific aggression criterion were randomized to the treatment period of the trial.
Results:
Of the 44 subjects enrolled, 23 (52.3%) met the aggression criteria for entering the treatment period (baseline nonresponders), while 21 (47.7%) did not (baseline responders). Thus, almost half of the subjects, while taking no active medication, benefited from the inpatient milieu/structure and/or placebo.
Conclusion:
This finding has important treatment and research implications. Medication to treat aggression should not be initiated immediately upon hospitalization because improvements associated with hospitalization may be attributed inaccurately to pharmacotherapy, resulting in unnecessarily medicating children. A placebo baseline period is essential to decrease the risk of a type II error in pharmacological research concerning aggression.
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