Our original hypotheses were that five primary indices regarding academic achievement and neurocognitive functioning would be significantly improved following treatment of participants with the CRP. The results from this Phase 3 clinical trial are equivocal. Participants experienced statistically significant improvement in academic achievement, incorporated more metacognitive strategies, and, on the basis of parental report, manifested improved attention. However, there were no statistically significant differences in neurocognitive functioning, even though trends were supportive of mild gains in neuropsychological development. It is our expectation that the clinical significance of the CRP will improve over time, particularly if caregivers continue to emphasize the skills that were taught. Nevertheless, this matter remains untested and is in need of further evaluation. We are now analyzing moderating and mediating factors regarding participants who benefited from the CRP versus those who did not. These are critical issues that will guide us in our efforts to provide more effective rehabilitative services.
Brain injury rehabilitation is a demanding task for both therapists and patients. The process is particularly complex in children/adolescents, because their brains are undergoing healing and development simultaneously, and the involvement of caregivers is critical. At this time, we report mixed results, with statistical significance in some areas and positive trends. In fact, as presented in , effect sizes (relative to the baseline standard deviation) tend to be within the .1–.5 range. As most of the measures were moderately correlated over time (ρ = approximately 0.5), estimation of the effect size relative to the standard deviation of the change scores resulted in similar estimates. The one exception was academic achievement, which was strongly correlated over time. The effect size estimates for this domain increased from .19 to .53.
An effect size in the range of .5 is within the medium range. Thus, participants who completed our CRP demonstrated improvement in their ability to successfully complete tests of arithmetic- and language-based functions, even though our treatment was not directed toward education. In sum, treatment produced the most prominent impact on measures of generalization. It remains to be seen whether or not these results will be stable and if they will have future ramifications in terms of postsecondary education.
It should be noted that brain injury rehabilitation is commonly characterized by small-to-medium effect sizes (Cicerone, 1999
; Cicerone et al., 2000
) and has typically been reported to result in very limited improvement in cognitive, educational, behavioral, and social domains (Anderson & Catroppa, 2006
). Although we have evidence of generalization of functioning to the academic arena, our findings are consistent with this pattern of limited effect.
Psychological and medical interventions are associated with modest treatment effects (Meyer et al., 2001
). Even with this evidence-based caveat, we are extremely interested in determining the degree to which our intervention will have a positive and lasting effect not only on future school performance but on development and quality of life. Ongoing research will be necessary to document these possibilities, and longitudinal designs will be necessary in this regard. There are clear questions regarding clinical significance. Our study did document improvement in academic functioning. However, these improvements are not clearly associated with neurocognitive functioning, which we considered to be a primary outcome variable of this clinical trial. This fact has caused our team to reevaluate the manner in which, we believe, that change is occurring in children/adolescents with brain injuries. The current study is very robust in terms of sample size and research methodology, but our results are less robust than anticipated. There are positive aspects to this clinical trial, in terms of significant improvement in academic performance and some aspects of attention in children who have suffered deficits following their CNS disease/treatment, but the findings also amplify the fact that much work must be directed toward pediatric brain injury rehabilitation.
Summary measures of neurocognitive functioning did not, for the most part, reveal a statistically significant level of improvement for the CRP participants. Composite measures all had acceptable internal consistency but were lowest on working memory. Working memory is emerging as an important mediator/moderator of intelligence and achievement declines in this population (Beebe et al., 2005
; Palmer et al., 2003
). Additional research is needed for development of an index that is sensitive enough to reliably measure this multidimensional cognitive function. Although CRP-treated participants demonstrated improvements on most neuropsychological measures, many control participants also demonstrated improvements. This result is likely due, in part, to practice effects. Our next generation of clinical trials must address this issue of concern, perhaps through the use of alternate form testing.
In addition, it is critical that researchers introduce strategies to increase compliance and intervention potency. Clearly, there is a need for greater developmental focus within this population, as advocated by Anderson and Catroppa (2006)
, who emphasized a multimodal approach that includes family- and school-based interventions. These have been the guiding theoretical and practical principles of the CRP approach, but greater emphasis is needed if we are to achieve more robust results.
We assessed the effect that treatment would have on self-esteem, as measured by the participant's report of mastery. Although there were no statistically significant differences between pre- and posttreatment scores on the culture-free self-esteem measure for either group, it may be naive for us to expect that these changes would occur so quickly.
Data were analyzed under an “intent-to-treat” model. This approach most accurately reflects real-world expectations, in that not all clinical patients complete a prescribed intervention trial, and it minimizes misinterpretation of data. Thus, the comparisons between study and control participants are not based on the effectiveness of the CRP as prescribed but are influenced by additional factors, such as compliance and dropout. In effect, the true potency of the CRP was not tested in the pure sense. As shown in , only 60% of participants in the CRP arm completed the entire regimen. However, 80% completed at least three quarters of the therapeutic intervention. Nevertheless, compliance is a concern. The CRP is a demanding commitment for families, and we are currently developing treatment revisions to address these issues. These revisions will help caregivers navigate the educational system more effectively, so the CRP can be incorporated into classroom work.
The current findings are, in our opinion, encouraging but also sobering. It is likely unreasonable for us to expect to be able to rehabilitate children/adolescents with a brain injury to a pre-CNS insult level of functioning. We believe, however, that it is incumbent on us to devise strategies that will ensure rehabilitation, compliance, and increased program potency. In addition, more extensive follow-up treatment and the possible benefits of adding booster sessions over time should be investigated.
Within the area of psychotherapy research, a subtractive model is typically encouraged. Once an intervention is proved effective, researchers dismantle their treatment methods to determine the specific causative intervention. In our opinion, this may be an ineffective approach for brain injury rehabilitation. Instead, we propose an additive strategy, given the difficulty in teaching significant others and the individual with neuropsychological impairment how to manage his or her cognitive resources, particularly when the individual is a child or adolescent.
We are instituting treatments to increase the impact of the CRP that are based on proven caregiver interventions (Sahler et al., 2005
). The use of these innovative methods represents a potential advance for pediatric cancer survivors and, we hope, all populations with pediatric brain injury.
Childhood brain injuries can have a devastating effect both on the ability of the individual to benefit from schooling and develop his or her foundation for a productive adult life and on family and social relationships over the course of the individual's life. The entire rehabilitation process suffers from poor funding and from treatments administered by individuals without formal training in brain injury rehabilitation. Continued research should be directed toward the administration of effective rehabilitation techniques. We believe that our data support this directive. The development of a comprehensive and collaborative team that includes the patient, therapist, caregivers, educational professionals, and other involved individuals who will marshal the necessary resources to promote commitment, involvement, and the lifetime use of skills taught during rehabilitation is essential. A new standard of care in pediatric outpatient brain injury rehabilitation must be advanced. The educational system is underfunded, and there are few adequately trained faculty and staff. Medical caregivers in the area of clinical neuropsychology, psychiatry, and pediatric neurology need to become more involved and should be appropriately funded.