A Delicate Brain: Ethical and Practical Considerations for the Use of Medications in Very Young Children

The debate is growing. Amidst federal inquiries into financial ties to pharmaceutical companies by researchers, decreasing interface between academic institutions and pharmaceutical companies, and decreasing research funding available from the NIH, the use of psychotropic medications-particularly atypical antipsychotics and stimulants-remains mired in controversy.¹

Absent significant changes to the current system of care and political climate and more research into the efficacy and long-term safety of psychotropic medications in children, this controversy will continue to grow.

Our youngest and most vulnerable children-those with significant mental health concerns for whom psychotropic medications are prescribed-are most affected by this controversy. The historical context for this controversy, the ethical implications of the current state of care for young children in the mental health care system, and the limited knowledge of the developmental neurobiological impact of these medications provide the background for a much-needed critical discussion.

Current prescribing practices compared with evidence-based treatments

Empirical research has shown that preschoolers can and do experience debilitating mental health problems that interfere with normal development and cause significant suffering for them and their families.² The concurrent and predictive validity of ADHD, major depressive disorder, PTSD, and disruptive behavior disorders are well established in preschool children. Early childhood mental health problems stabilize over time; however, they are associated with substantial impairment in multiple developmental domains.

There is evidence that early psychological disorders increase the risk of mental health problems across the person’s life span. Although awareness of early childhood mental health problems has increased, this awareness has not translated into substantial empirical support for psychopharmacological interventions in this age-group or into increased access to nondrug interventions.

A substantial body of literature supports the efficacy of nonpharmacological treatments for young children. For example, there are more than 100 randomized controlled trials of parent-child interaction ther­apy-a training program that assists parents of children with disruptive behaviors. Parents are taught effective child management skills to improve both disruptive behaviors in their children and their relationship with their children. These trials show that effects are maintained up to 6 years after treatment has ended.³

Cognitive-behavioral therapy, with developmental modifications, has been found to be effective in decreasing anxiety symptoms in trauma-exposed preschoolers, with sustained results at 12-month follow-up.⁴ Child-parent psychotherapy-an attachment-based intervention-is effective in decreasing child and parent trauma-related symptoms following partner violence.⁵

Despite this significant evidence base for the effectiveness of psychotherapeutic interventions since the 1990s, studies have documented increasing rates of psychopharmacological prescriptions for children younger than 6 years, which has stirred impassioned responses in the lay press.^6-8 Zito and colleagues reported a 3-fold increase in prescriptions for 2- to 4-year-old Medicaid-enrolled children between 1991 and 1995,⁶ followed by another doubling by 2001.^9-12 By 2001, 2.3% of Medicaid-enrolled preschoolers received a prescription for a psychopharmacological agent.¹² A more recent study demonstrated another doubling in rates of prescriptions for atypical antipsychotic agents for privately insured preschoolers from 2000 to 2007.^13,14 Psychopharmacological agents are most commonly prescribed for children with ADHD and disruptive behavior disorders. In addition, however, medications, particularly antipsychotics, are often prescribed for children in this age range who have been given a diagnosis of bipolar disorder-a disorder whose validity in the preschool population has not been established.¹⁵

Importantly, factors beyond clinical symptoms appear to play a role in these prescriptions. Across studies, insurance status (public more than private insurance), sex (boys more than girls), race (whites more than blacks), and population concentration (rural more than urban areas) are related to children receiving prescriptions for psychopharmacolog­ical agents.^12,13,16 Studies also highlight a relative lack of use of psy-chotherapeutic interventions, the first-line treatments for most mental health problems in preschoolers. Fewer than 40% of children who were given antipsychotic agents received psychotherapy either concurrently with or before initiation of drug therapy.^14,17

Political environment and current FDA approvals

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