This pilot study is the first RCT to evaluate the feasibility and preliminary efficacy of an individually tailored behavioral treatment for nonadherence in youth with IBD. In general, data from the present study suggest that an individually tailored approach to adherence promotion is a viable treatment option that requires larger-scale investigation. The 100% retention rate of patients indicates this 4-session treatment intervention is a feasible approach for treating nonadherence. Additionally, the intervention was rated favorably in terms of acceptability by both patients and their parents. Several aspects of this treatment may have increased perceptions of acceptability. For example, treatment sessions were scheduled at times that were convenient for families. In addition, compared with group interventions that focus on issues shared by multiple families, this intervention provided more time for individualized problem solving of families’ unique barriers. Some of the common barriers targeted for intervention in the present study included forgetting to take medications, poor planning for taking medication during other activities, parent–child communication skills regarding adherence, and diffused responsibility for adherence between parents and adolescents.
Overall, improvements in adherence were substantially better for mesalamine than for 6-MP/azathioprine, with a medium effect size and 25% improvement in adherence for mesalamine. This discrepant change in adherence across medications may reflect differences in the regimen complexity between these 2 drugs. Although newer mesalamine preparations can be prescribed as once-daily dosing, mesalamine is often prescribed as several pills taken 2 to 4 times daily and 6-MP/azathioprine is usually prescribed as 1 to 2 pills taken 1 to 2 times daily (16
). With a greater number of doses and pills per dose, there is likely an increased variability in adherence and consequently more opportunities to make significant adherence gains. It is also plausible that an individualized treatment protocol allows families to target more complex treatment regimens first because these are more burdensome and difficult to adhere to, resulting in greater improvements over time compared with less-complex treatments. In addition, medication-specific barriers to adherence such as fear of medication adverse effects, which may particularly affect 6-MP/azathioprine, may have resulted in more modest adherence gains compared with mesalamine. Regardless, this finding suggests that an individually tailored, adherence-focused intervention may be particularly useful and beneficial for chronically ill youth following complex medication dosing regimens. Moreover, this finding is especially relevant given that mesalamine is one of the most commonly used maintenance drug therapies to treat pediatric IBD, particularly ulcerative colitis.
There are several noteworthy strengths of the present study. First, the RCT study design provided control over maturation effects at the primary endpoint, thus increasing the likelihood that the observed changes in adherence were the result of the treatment used. The present study also used a validated and objective measure of adherence (ie, pill counts) that is feasible for use in clinical settings (1
). Finally, a multifaceted assessment of treatment feasibility and acceptability, which is uncommon in studies of this nature, was an important component of the present study. Indeed, these data are critical to understanding the clinical utility of this treatment approach and support the rationale for developing and testing a larger RCT of an individually tailored, adherence-focused intervention in pediatric IBD.
These findings also should be interpreted in the context of some limitations that carry important implications for future research. First, this was a pilot study and is consequently limited by the small sample size and lack of long-term follow-up, which precludes broad generalization of the findings. Effect sizes were calculated to estimate the effect of the treatment on medication adherence, but large-scale testing is necessary. Also, it is possible that several months after the intervention, adherence will have returned to baseline for some patients. A larger clinical trial with long-term follow-up will be able to provide data on the types of patients who relapse and optimal timing for follow-up intervention. Second, demographic characteristics of the sample (ie, adolescents, white, married caregivers, high household income), although representative of other published pediatric IBD studies (5
), may not adequately characterize the larger IBD population. Third, multiple measures of adherence were not obtained. Although pill counts are a feasible, reliable, and objective measure of adherence to oral medication (1
), future research should incorporate additional measures of adherence to examine patterns of nonadherence, which also will facilitate individual tailoring of this intervention. Moreover, a multimethod assessment approach to adherence may provide more reliable and informative adherence estimates (18
). Assessment of medications in addition to 6-MP/azathioprine and mesalamine also will provide more comprehensive data regarding adherence difficulties in these patients. Lastly, the scope of the present study precluded an analysis of the differential effect of various intervention components (eg, organization, problem solving, behavior modification) on treatment adherence. Future research that dismantles components of adherence intervention may prove particularly beneficial and may guide subsequent clinical intervention and practice.
The present study provides preliminary evidence for individually tailored treatment of nonadherence to oral medication among chronically ill youth. It is plausible that this type of treatment for nonadherence would be beneficial for other conditions that are treated with oral medications. Because the prevalence of nonadherence among youth with chronic medical conditions is high, it will be important to determine the extent to which individually tailored adherence intervention is useful and effective at improving outcomes. Individually tailored interventions offer important benefits that group-based interventions cannot, including a focus on families’ specific and unique barriers to treatment adherence and the potential for delivery of treatment sessions in conjunction with regular clinic appointments. It is anticipated that further evaluation of this type of intervention in large-scale trials will yield salient findings regarding its efficacy and generalizability and that effectiveness research will demonstrate its clinical utility.