Mary Margaret Gleason, MD

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.

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.

 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.

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.

 Child-parent psychotherapy-an attachment-based intervention-is effective in decreasing child and parent trauma-related symptoms following partner violence.

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.

 Zito and colleagues reported a 3-fold increase in prescriptions for 2- to 4-year-old Medicaid-enrolled children between 1991 and 1995,

 By 2001, 2.3% of Medicaid-enrolled preschoolers received a prescription for a psychopharmacological agent.

 A more recent study demonstrated another doubling in rates of prescriptions for atypical antipsychotic agents for privately insured preschoolers from 2000 to 2007.

 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.

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.

 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.

Political environment and current FDA approvals

In 2002, Congress passed the Best Pharmaceuticals for Children Act, which provides extended patent exclusivity for medications tested for pediatric indications.

 Despite this incentive, there have been only 2 randomized controlled studies that have focused primarily on the preschool age–group, both of which examined treatment of ADHD (methylphenidate and atomoxetine). The literature suggests that psychopharmacological agents are less effective and are associated with higher rates of adverse effects in young children than in older children.

lists the current FDA-approved indications and age ranges for stimulants and antipsychotics in children. Notably, 2 of the medications approved for preschoolers are typical antipsychotic agents. Methylphenidate, which has the most empirical support for safety and efficacy in the preschool age–group, has a specific warning against use in preschoolers.

The rapid advancement of neuroscience and the increasing interaction with psychiatry have raised new considerations about the use of atypical antipsychotics and stimulant medications in young children. The developing brain is exquisitely sensitive to neurotransmitter levels, and their expression gradients are critically important for normal development and plasticity of the CNS. Alterations in the levels of monoamines and other neurotransmitters, as a result of environmental exposures or medications, are expected to influence the development and maturation of the underlying neural circuits, particularly during periods of rapid neurodevelopment, such as the first years of life.

There is a paucity of research on the long-term consequences on brain development and function following exposure to atypical antipsychotics and stimulant medications. The information to date has been extrapolated from preclinical animal research and from studies of children exposed prenatally to psychopharmacological agents. Animal studies have examined the cognitive impact of early exposure to both atypical antipsychotics and SSRIs and have shown associations between early exposure to these medications and deficits in cognitive function, spatial memory, and alterations in neuro­transmitter receptor distribution.

Administration of methylphenidate to young rodents resulted in alterations in neurotransmitter receptor densities, particularly dopamine.

 Behavioral studies have demonstrated alterations in motivation, reward pathways, and spatial memory in juvenile normal rodents following early exposure.

 However, caution is warranted when extrapolating these data to children with psychiatric diagnoses such as ADHD. In these children, there is increasing evidence of neurodevelopmental differences independently associated with psychiatric diagnoses. When 2 medications are combined, the risks to the developing brain likely increase exponentially, with unknown impacts on neurodevelopment. Thus, extreme caution is warranted with the use of multiple psychotropic medications because of the limited evidence base for efficacy of single medications in young children and the complete lack of efficacy for multiple medications in young children.

The ethical implications of the current state of use of psychotropic medications in young children are many and represent a call to arms. The key ethical principles of non­maleficence, justice, and beneficence are all relevant to this discussion.

 As physicians, we began our service to patients with the Hippocratic Oath 

 (at first do no harm). Given the lack of efficacy data for the use of psychotropic medications in children and the significant known adverse effects, the principle of nonmaleficence is applicable.

However, the disconnect between the implementation of evidence-based interventions and the elevated use of psychotropic agents high-lights the principles of beneficence and justice. Justice requires that all young children be able to access effective and appropriate clinical care. Currently, inadequate insurance reimbursement for developmentally appropriate assessment of and psychotherapy for young children,

 the critical shortage of mental health providers trained in the care of young children, the absence of federal support for the needed intervention research, and the lack of funding to implement the existing evidence-based treatments all conspire against justice in the mental health treatment of very young children. Specifically, clinicians who serve young children do so with substantially less information, fewer proven treatment options, and more limited access to psychotherapeutic first-line treatments than those who serve older children and adults. The increasing evidence that the use of atypical antipsychotics and other psychotropic medications is occurring at higher rates in certain ethnic populations and in children in the child welfare system highlights a failure to apply the principle of justice that demands that all groups be equally treated.

Consideration of beneficence in mental health treatment of young children is critical. Families that have children with significant mental health issues are in crisis. Often they have struggled for years before seeking assistance. Withholding all medications in young children is in direct opposition to the principle of beneficence. Beneficence requires that clinicians use their best clinical judgment, incorporating parents’ goals and values and the current evidence, to alleviate suffering, enhance safety, and balance the potential benefits with the risks of untreated or undertreated psychopathology. Until we have sufficient evidence, these decisions will continue to be fraught with uncertainty. The issue is controversial: some suggest that psychopharmacological agents may be neuroprotective in children with mental illness, while others view the use of medications in preschoolers as universally unacceptable. To date, we do not have the data to resolve this controversy.

To move forward will require a concerted effort across multiple systems. We must address the critical shortage of child mental health providers at all levels. Federal efforts to address this shortage, such as the currently approved but as yet unfunded Child Health Care Crisis Relief Act (H.R. 1932/S. 999), would provide student loan repayment for child health care providers and training stipends directly to institutions to support the training of child psychiatrists, psychologists, and social workers. Efforts to get this program funded are needed. Mental health care policies must be reformed to provide adequate reimbursement for the comprehensive assessments recommended by clinical guidelines as well as to provide for the implementation of psychotherapeutic evidence-based modalities in young children.

Treatment of parental mental health problems, a well-established approach to reducing child mental health symptoms, is promised through the Affordable Health Care Act and must be linked to child mental health care services. Existing guidelines for the use of psychotropic medications in young children should be implemented. The Best Pharmaceuticals for Children Act has called for more research on both the developmental neurobiological impact of stimulants and antipsychotics and the long-term efficacy and safety of these medications. Implementation of these recommendations would make substantial progress toward ending both the historically disproportionate lack of information on treating young children with these medications and the inadequate approach toward young children’s psychopathology. Effective, early intervention and appropriate support for and treatment of the caregivers of these vulnerable children will improve short-term outcomes and also may provide positive lifelong benefits.

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Articles

 Effective, early intervention and appropriate support for and treatment of the caregivers of these vulnerable children will improve short-term outcomes and also may provide positive lifelong benefits.

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

Infant, or developmental, psychiatry is a subspecialty of child and adolescent psychiatry that focuses on the promotion of mental health in infants, toddlers, preschoolers, and their families through the consultation, assessment, and treatment of clinical problems.1 This specialty is a strength-based, prevention-focused discipline founded on the belief that early intervention for children in high-risk settings or with clinical problems can positively impact emotional and behavioral development.

While, as a society, we prefer to view early childhood as a carefree period, young children can still experience significant mental health problems.

 Early identification of these problems provides the opportunity to improve developmental outcomes by changing a child's developmental trajectory. Infant psychiatrists apply psychiatric diagnostics and treatment principles as they collaborate on multidisciplinary teams to support the child's mental health. The following case study we present of Karen's family situation is not uncommon in infant psychiatry.

Karen is a 34-month-old girl referred for infant mental health assessment by a physician who was treating her with a neuroleptic drug for aggression. Karen presented with anxiety symptoms and "bad" behaviors including being aggressive, irritable, and oppositional in the context of an escalation of family violence. An interview with her mother revealed a fear of Karen as a powerful aggressor: "She is mean, just like her father." In observations, Karen provided cues that were confusing to her mother, such as approaching her for comfort but then hitting her. A multidisciplinary team developed a plan that included safe housing, discontinuation of the neuroleptic drug, dyadic treatment using principles of child-parent psychotherapy to promote development through dyadic play, reflective guidance, and interpretations linking history to in-session experiences. In addition, Karen's mother was treated psychopharmacologically for posttraumatic stress disorder and Karen was referred for a speech and language assessment. Over the course of the next few months, Karen's aggression decreased, her sleep improved, and mother and daughter began to show true enjoyment during their interactions.

Infant mental health (IMH) refers to the emotional well-being of children in the first few years of life, with attention to 2 central contexts: early developmental processes and the parent-child relationship. In this period, development unfolds at an unprecedented rate and clinical intervention must take into account the rapid processes of development as well as the child's developmental trajectory. In infancy, external contextual factors--including family stressors--are experienced through the buffer or filter of the parent-child relationship. Family, community, school, and cultural contexts also become increasingly prominent in the child's experience of the world and must be considered as part of IMH practice.

The treatment of infants requires skills specific to the population. Most senior specialists in this area have developed expertise through experience, mentoring relationships, and peer support. Increasingly, formal programs are available for subspecialty training. The American Academy of Child and Adolescent Psychiatry (AACAP) Web site lists 21 programs that provide infant psychiatry training.

 This specialty training typically includes a focus on social-emotional development, theory and skills related to parent-child relationship assessment and interventions, application of diagnostic nosologies to young children, and the unique issues of psychopharmacology within this age group.

Many infant psychiatrists participate in academic medicine, building an evidence base for this growing field. Some recent advances in infant psychiatry in collaboration with other disciplines include:

Developmentally appropriate diagnostic tools and nosologies for the preschool age group.

Validation of specific psychiatric disorders in young children.

Randomized controlled studies documenting the effects of quality foster care on children raised in institutions.

 A preliminary understanding of the neurobiologic effects of trauma on young children, their parents, and the parent-child relationship.

Most infant psychiatrists work on IMH teams in academic medical settings, mental health agencies, or specialty settings, including child protection agencies. The teams can include a psychiatrist, a psychologist, masters-level clinicians, and case managers. Physicians can have a range of roles on the team--depending on individual exper-tise--and they always bring a biologic perspective by identifying prenatal and perinatal events, dysmorphology, and medical illnesses or medications that may contribute to the presenting problem. IMH teams typically collaborate with other providers, including early intervention teams, speech therapists, and pediatricians. Successful teams also develop close ties with community resources to assist families in meeting their basic needs.

Referrals for IMH assessments come from a range of sources, including caregivers, pediatricians, child care providers, and child protective services. Common referral concerns include sleeping or feeding difficulties, problems regulating affect or attention, relationship problems, and aggressive behaviors.

The assessment process has multiple purposes. The primary goal is to collaborate with caregivers to develop a shared understanding of the child within a developmental and relational context. To this end, it is critical to build a positive working alliance with caregivers and provide information and feedback about normative and atypical development.

 Assessments should take place over multiple sessions in multiple settings and include all possible caregivers.

Caregivers sometimes come to the assessment process feeling anxious, helpless, or blamed. Addressing caregiver distress about the process is critical to building an alliance and combating misconceptions. An equally important process is vigilant monitoring of a clinician's response to the wide range of parenting behaviors and family practices.

One of the challenges of IMH assessment is that infants cannot communicate verbally about their internal states. Thus, observations and indirect assessments are necessary components of the evaluation. Although a child's behavior typically precipitates the referral, the infant-caregiver relationship is a transactional process. Infants influence caregivers, and caregivers influence infants.

 In this interactive, dynamic relational system, children's presenting problems invariably impact, and are impacted by, the caregiving relationship.

Typical assessment includes a developmental assessment, a clinical interview, structured and unstructured behavior observations, and a caregiver report on norm-referenced measures--all of which provide data that are integrated into a formulation of the child's competencies and deficits in the context of his or her primary relationships. All assessments should include attention to motor, cognitive, neurobiologic, speech and language, and social-emotional development. Because infant development is inextricably embedded in family and community contexts, socio-economic factors, parent depression, parent substance abuse, parent-partner violence, and trauma history should be assessed.

As in all psychiatric assessments, a complete history of the child and his family is a necessary component of assessing IMH. The child's history begins before conception and continues through the history of the presenting problem, with attention to major life stressors, medical problems, and developmental milestones. The family's history provides valuable information about biologic loading as well as the caregiving context. Social history, with attention to social support networks and stressors, is critical to developing a complete formulation.

Assessment in IMH must be relationship-based. A parent's behaviors and his or her perception of the child, as well as the child's behaviors within the relationship, can be elicited during the assessment. The psychiatrist must infer the infant's perception of the parent. Observations of infant-caregiver interactions provide information about the child's development, caregiver functioning, and the infant-caregiver relationship.

In a clinical assessment, it is useful to observe the dyad interacting in unstructured ways, such as during history taking, and in more formal activities, including free play, clean up, opportunities for joint attention, and teaching tasks.

 A brief separation and reunion is often employed during assessments to activate the young child's "attachment system," which provides information about how the child uses a caregiver for comfort when distressed. In addition, a clinician can observe a caregiver's warmth, sensitivity, affective involvement, approach to noncompliance, developmental expectations, and limit setting. During the structured and unstructured observations, the clinician can examine a child's development level, use of caregiver for social referencing, and regulatory capacities.

Parent perceptions of the child, which are associated with attachment security, can also be explored through the content and quality of the parent's descriptions of the child during the clinical interview. The Working Model of the Child Interview

 is a formal interview intended to assess the nature of the parent's perception of the child. By evaluating the manner in which the parent talks about the child; coherence of the narrative; flexibility of the working model; sensitivity; intensity of affective involvement; and acceptance of the child, the parent perception can be categorized as balanced, disengaged, or distorted and can be used in both clinical and research settings.

While some families referred for an IMH assessment merely require reassurance, many of the children referred have a clinically significant psychiatric disorder. For these families, the application of a widely accepted nosology by clinicians facilitates communication across providers, tracking of the developmental course of the disorder across age ranges, and use of diagnosis-specific interventions, as well as access to third-party payer systems.

is important because of its utility within the broader health care system, but it is limited by its lack of a developmental approach. Using research and expert consensus, the AACAP developed Research Diagnostic Criteria-Preschool Age (RDC-PA), a modification of 

, to allow the consistent application of developmentally sensitive nosology in research.

 Another resource, developed by the Zero to Three Diagnostic Classification Task Force, is the 

Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood, Revised (DC:0-3R),

 which incorporates classifications from the RDC-PA into a revision of the evidence-based alternative nosology and includes an axis to specifically designate relationship problems.

In infant psychiatry, intervention approaches range from universal prevention models to targeted treatment for established psychopathology. Preventive approaches include legislative advocacy for high-quality child care, family health and mental health coverage, and reduction of poverty.

A common theme, regardless of specific prevention models, is strengthening the parent-child relationship, which is accessed through the parent's internal working model of the child, dyadic interactions, and parent or older child behaviors. The growing literature describes evidence-supported practices for intervention in children who are in extremely high-risk settings or who demonstrate psychopathology. These interventions are derived from a range of theoretic perspectives--including attachment, object relations, and social learning theories--as well as behavioral approaches. One well-known model of secondary prevention is the Nurse-Family Partnership that was developed for economically disadvantaged first-time mothers. The intervention, which involves home visits by a nurse during pregnancy and through the second year of life, is associated with marked reductions in reported cases of child abuse, accidental injuries, the number of subsequent pregnancies, and adolescent incarcerations compared with a randomized control group.

An example of attachment-based psychotherapy is infant-parent psychotherapy (IPP) and its companion, child-parent psychotherapy (CPP). In IPP and CPP, the parent and child are present during sessions in which healthy development is promoted through dyadic play, reflective guidance, and interpretations linking a parent's early caregiving relationship experiences to the parent-child interactions in the room.

 A number of studies have documented an association between these treatments and positive changes in parent perception of child, child self-perception, and child symptomatology.

 Other attachment-based therapies with foster parents and foster children demonstrated normalization of baseline cortisol levels compared with levels in children receiving intervention as usual, as well as improved quality of parent-child interactions.

Cognitive-behavior therapy has also been shown to be effective in young children. Specifically, trauma-focused cognitive-behavior therapy with parent involvement reduces symptoms in sexually abused preschoolers on the Child Behavior Checklist compared with a supportive intervention, with persistent improvements 1 year after treatment.

In older preschoolers, a number of well-researched parent-training programs based on social learning principles are effective for disruptive behavior disorders.

 The Incredible Years Series (IYS) is a cognitive-behavior program developed to prevent and treat conduct problems in early childhood.

 The IYS parenting program uses an active collaborative approach to teach skills within a group context, including use of videotaped vignettes, role-playing, written materials, and home practicing. The BASIC Parent Program focuses on developing skills in play and reinforcement, effective limit setting, and discipline techniques; the ADVANCE Parent Program for high-risk parents provides additional training in self-control, communication, and problem solving.

In randomized controlled trials, the BASIC program has demonstrated clinically significant improvements in parenting practices and child conduct problems, including remission from oppositional defiant disorder.

 Similarly, the ADVANCE program is associated with notable improvements in parent-child interaction, communication, problem solving, and child adjustment.

Parent-child interaction therapy (PCIT) is an individualized, relationship-focused intervention based on behavior theory for children aged 2 to 6 years who are referred for disruptive behavior disorders.

 PCIT has been effectively adapted for use in high-risk populations, including children with physically abusive parents.

 In PCIT dyadic sessions, parents receive live coaching from the therapist behind a one-way mirror using a "bug-in-the-ear" microphone. Parent collaborative teaching sessions are followed by in-session and at-home practice. PCIT uses a 2-stage model to target parent behaviors: (1) child-directed behavior play therapy skills (ie, praise, reflection, imitation, description) and effective reinforcement, and (2) parent-directed interaction techniques, including effective commands, consistent limit setting, ignoring, and time-out. Growing research evidence supports the efficacy of PCIT in improving parenting skills and providing clinically significant reductions in oppositional and aggressive behavior.

Efficacy and safety data regarding the use of psychopharmacologic treatment in children under 5 years are lacking.

 These agents are used with caution in this age group and should be considered only after a trial of appropriate psychotherapy is unsuccessful. On the other hand, parental psychopharmacologic treatment when indicated can be very useful in combination with dyadic interventions.

Infant psychiatry offers exciting opportunities in clinical and research settings. The specialty requires true integration of biologic, psychological, and social intervention strategies--with collaboration across disciplines. Infant psychiatrists can intervene early to promote current and future healthy development and relationships and treat a wide range of psychopathology in infants. The growth and development of this specialty, like early childhood development itself, is rapid and holds extraordinary potential to promote family mental health and treat psychopathology.

Dr Gleason is a clinical assistant professor in the department of psychiatry and human behavior at Brown Medical School in Providence, RI, and at the Institute of Infant and Early Childhood Mental Health at Tulane University Health Science Center in New Orleans as well as a research fellow in child psychiatry at Rhode Island Hospital in Providence.

Dr Doctoroff is a clinical psychology research fellow in the department of psychiatry and human behavior at the Brown Medical School and at the Bradley Early Childhood Clinical Research Center at Rhode Island Hospital.

Both authors report that they have no conflicts of interest regarding this article.

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Infant, or developmental, psychiatry is a subspecialty of child and adolescent psychiatry that focuses on the promotion of mental health in infants, toddlers, preschoolers, and their families through the consultation, assessment, and treatment of clinical problems.