Developing an Effective Treatment Protocol

Anxiety disorders are the most prevalent disorders among children and adolescents in both community and clinical settings. The high prevalence of anxiety disorders in children and adolescents leads to increased interest in the development and implementation of effective treatments. Anxiety disorders in children and adolescents are often associated with significant psychosocial impairments (eg, poor social relationships, decrease in academic performance, low self-esteem), and untreated anxiety tends to persist through adulthood.^1,2

An effective treatment for anxiety disorders in children is cognitive-behavioral therapy (CBT).³ However, some children with anxiety disorders demonstrate minimal response to CBT alone. When children and adolescents show minimal response to a trial of CBT, psychotropic medications are often added for a multi- modal treatment approach.⁴ SSRIs are documented to be effective in the treatment of anxiety disorders in children.⁵ Most studies reviewed in this article include participants in whom generalized anxiety disorder, social phobia, or separation anxiety disorder was diagnosed.

Cognitive-behavioral therapy

CBT has been shown to be effective in the treatment of childhood anxiety disorders when used in individual, group, family, and school-based settings. Six essential components of CBT have been identified for the treatment of anxiety disorders in children: psychoeducation, somatic management, cognitive restructuring, problem solving, exposure, and relapse prevention.⁶

• Psychoeducation provides families and children with information on anxiety disorders.
• Somatic management techniques (eg, diaphragmatic breathing, progressive muscle relaxation) increase awareness and management of autonomic and physiological symptoms related to anxiety.
• Cognitive restructuring strategies require that the child monitor his or her thought processes to recognize maladaptive, irrational thoughts and that these thoughts be replaced with more adaptive, rational thoughts.
• Problem-solving methods are taught to the child so that he can identify coping strategies to manage anxiety-provoking situations.
• Exposure exercises include hierarchical and systematic exposures to feared stimuli, which provide the child with practice in managing associated anxiety symptoms.
• Relapse prevention (eg, decreasing session frequency while scheduling follow-up or booster sessions) is an important component of CBT because it encourages the child to take more control over his anxiety and to rely less on the therapist.

Individual and group CBT were shown to be consistently superior to a wait-list control condition (ie, no treatment) in children with anxiety disorders.^7-9 Longitudinal research studies have shown that treatment gains with individual CBT were maintained and enhanced at 3- and 7.5-year follow-up.^10,11 Flannery-Schroeder and Kendall⁹ compared individual CBT with group CBT and found that the interventions were equally effective and treatment gains were maintained after a 1-year period in children with anxiety.¹²

Furthermore, group CBT has been successfully used in school-based settings as a preventive and early intervention effort to target children with anxiety symptoms.^8,13 Outcomes from these studies showed a decrease in anxiety symptoms or remission of anxiety in children who received school-based group CBT intervention compared with children who did not.

Studies have shown mixed results when a parent-training component is added to CBT. Some studies have shown no added benefits when parents were involved in their children's anxiety treatment^14,15; however, other studies found some favorable outcomes when a parent component was added to the traditional child CBT model.¹³

In one study, children who participated in school-based group CBT or school-based group CBT with parent training were rated as having significantly less anxiety at posttreatment compared with children in the no-treatment control group.¹³ The parent component of the intervention included information on the following topics: the 6 components of CBT⁶ (described earlier), parental anxiety and stress management, the impact the child's anxiety had on family relationships, and implementation of behavioral contracting.

Further benefits were found in children whose parents participated in a parent-training component. On 2 outcome measures, the Clinical Global Impression (CGI)-Improvement Scale and the parent version of the Multidimensional Anxiety Scale for Children, significant benefits were found for children in the CBT with parent-training group compared with no-treatment controls but not for children in CBT alone compared with no-treatment controls. These results suggest that the inclusion of a parent-training component may provide added benefits to children with anxiety who receive group CBT.

Wood and colleagues¹⁶ developed a family component that specifically targets parental intrusiveness and lack of child autonomy, since these factors are shown to play a central role in the maintenance of childhood anxiety disorders.^17,18 The parent-training sessions encouraged parents to provide choices for their anxious child when he is indecisive, allow their child to learn through mistakes rather than taking over to protect him, validate their child's emotional responses, and support their child's development of self-help skills.¹⁶

A family CBT program was compared with a child CBT program with limited parental involvement. The child CBT program was composed of individual sessions with the child, and the family CBT program was composed of sessions that consisted of time with the child alone, parents alone, and parents and child together. Children in the family CBT group demonstrated a greater decrease in anxiety severity at a faster rate compared with children in the child CBT group.¹⁶ Previous parent programs strove to train parents to support CBT skills at home and manage parental anxiety¹³; however, it may be important for parents to learn specific parenting strategies to aid in the reduction of the child's anxiety (eg, decrease parental intrusiveness, increase child autonomy seeking).

A recent study by Victor and colleagues¹⁹ examined the relationships among family functioning, parenting stress, parental psychopathology, and treatment outcome in anxious children. Results showed that a higher level of family cohesion before participating in group CBT was associated with a significantly greater decrease in child anxiety posttreatment. Parenting stress and parental psychopathology were not directly related to treatment outcome; however, parents from families with low cohesion endorsed significantly greater levels of parenting stress and parental psychopathology (ie, depression, anxiety, global severity) when compared with families high in cohesion. Thus, family cohesion may function as a mediator when there are high levels of parenting stress and parental psychopathology. Furthermore, these findings provide additional support for including a parent or family component in the treatment of children with anxiety.

Psychotropic medications

Psychopharmacological treatment is often considered for the treatment of anxiety disorders in children when symptoms are severe and significantly interfere with daily functioning (eg, school refusal, difficulty with participating in social activities) and children are exhibiting a minimal response to CBT. SSRIs are the first-choice medications for treating anxiety disorders in children and adolescents.⁴ Several randomized clinical trials (RCTs) support the efficacy of SSRIs in decreasing anxiety symptoms and in the short-term safety of SSRIs in youths.^5,20-22

When examining pharmacological treatment effects in children who are anxious, RCTs often include children with generalized anxiety disorder, separation anxiety disorder, or social phobia. A multicenter study examined outcome following 8 weeks of treatment with fluvoxamine versus placebo and found that fluvoxamine had a significantly greater impact on reducing anxiety symptoms.⁵ Birmaher and colleagues²⁰ completed a 12-week RCT comparing the effects of fluoxetine and placebo on children with anxiety. Results showed that children who received fluoxetine were more likely to be rated as much or very much improved on the CGI compared with children who received placebo. These studies provide support for the efficacy of SSRIs as treatment for anxiety disorders in children.

A literature review by Safer²³ examined the efficacy of SSRIs in children and adolescents with depression or anxiety disorders using published RCT data. The review demonstrated that SSRIs when compared with placebo do not significantly reduce depressive symptoms in children; however, a modest degree of efficacy was found when using SSRIs with depressed adolescents.

In contrast, published data (such as presented earlier) provide evidence that children and adolescents with anxiety disorders demonstrate significant improvements when treated with SSRIs. The review by Safer²³ indicated that SSRIs are probably more effective when treating children and adolescents with anxiety disorders rather than with depression.

Black box warning considerations

Although children and adolescents who participated in RCTs reported minimal adverse effects with medication, there continues to be concern regarding the use of medication to treat childhood anxiety and depressive disorders. The FDA now requires a black box warning on SSRI medications that states "antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders."²⁴

In a meta-analysis of 24 controlled clinical trials of antidepressants with youths, Hammad²⁵ demonstrated that the risk of adverse suicidal events was approximately 4% for youths receiving antidepressants versus approximately 2% for those receiving placebo.

Another meta-analysis of 21 studies of antidepressants in youths, including 14 treatment trials for major depression and 7for anxiety disorders, looked at the safety of SSRIs in children and adolescents.²⁶ These studies included the original data provided by the drug manufacturers to the FDA in 2003.

The overall findings from this meta-analysis showed that the incidence ratio for serious suicidal events (eg, suicide attempt or suicidal ideation necessitating hospitalization) was 1.89, which represents a significant difference between drug and placebo for risk of suicidal events. Results were similar when the meta-analysis was repeated using only the 14 trials of youths with major depression. The incidence ratio was 1.95, which also showed a significant difference between drug and placebo on risk of suicidality. However, when only the 7 studies of youths with anxiety disorders were included, there was no significant difference between antidepressants and placebo with regard to suicidal events (incidence ratio = 1.31).²⁶ Since fewer studies were included in the examination of the effects of antidepressants for treating anxiety, the latter result should be viewed as preliminary.

The black box warning on increased suicidality in children and adolescents who are being treated with SSRIs has led to substantial concern from parents and health care professionals. The use of antidepressant medications in persons aged 18 years or younger declined approximately 20% after the FDA released the first public health advisory warning in March 2004 about the increased risk of suicidality associated with antidepressants in children and adolescents.²⁷ This suggests that parents may be less likely to seek antidepressant medication treatment in a clinical setting and some physicians may be overly cautious about prescribing this type of medication for children and adolescents, which results in some children not getting needed treatment.

Another concern is that the black box warning may impact parents' willingness to allow their children with anxiety to participate in research studies that include an SSRI component. Pretreatment attrition caused by medication concerns has been a substantial problem in previous studies and limits external validity of the research results. Young and colleagues²⁸ reported a 67% pretreatment attrition rate in their study of social phobia in children and adolescents that included behavioral therapy, fluoxetine, and placebo. The most common reason given by parents who refused to allow their children to participate was fear of possible randomization to the medication group, which accounted for 45% of refusals.

In another study, parents answered a questionnaire about whether they would allow their children to participate in a hypothetical study that included an active medication group.²⁸ A majority (64%) said they would not allow their children to participate, with the most common reasons being potential adverse effects and dependence on the medications. These data were collected between May 2001 and September 2004; therefore, resistance to medications was present before the black box warning. It is suspected that parental concern regarding antidepressants has increased since the inclusion of the black box warning.

Conclusion

Current research on the treatment of anxiety disorders in children is important for treatment in clinical settings. It is imperative that clinicians use data to develop and implement effective treatment protocols for children and adolescents with anxiety disorders.

When clinicians are developing a treatment protocol, it is vital that they assess the severity of anxiety, degree of interference, and the level of family functioning. The most effective treatment strategy will likely include a multimodal approach that comprises both psychosocial and psychopharmacological interventions.

Although knowledge about the treatment of childhood anxiety disorders has significantly progressed during the past 10 years, there are areas that need further exploration. It is crucial that future studies attempt to delineate specific treatment mechanisms of CBT and identify specific predictors of positive treatment outcome in childhood anxiety. In addition, research that examines the combined efficacy of CBT and medication versus CBT or medication alone in the treatment of anxiety disorders in children is needed to develop guidelines for combining and sequencing these effective treatments.

Currently, the Child and Adolescent Anxiety Multimodal Treatment Study is being conducted to compare several treatment modalities²⁹: medication, CBT, medication and CBT, and pill placebo. The results from this study will provide important information regarding treatment of childhood anxiety disorders.

References:

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