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OBJECTIVE To compare spatial pain modulation capabilities between adolescents with and without migraine. BACKGROUND Conditioned pain modulation (CPM) responses at the leg are similar in adolescents with versus without migraine. However, the anatomical region of testing may affect spatial pain modulation capabilities as differences in nociceptive processing between patients with migraine and healthy controls are found in local areas that are near the site of clinical pain but not in nonlocal areas. This study aimed to examine spatial pain modulation capabilities tested by the CPM paradigm using test stimulus applied to a local body area. METHODS Nineteen adolescents with migraine (age 14.9 ± 2.3, mean ± SD; 16 female) and 20 healthy adolescents (age 13.8 ± 2.5, mean ± SD; 16 female) completed this case-control study at Cincinnati Children's Hospital Medical Center. Pressure pain thresholds (PPT) were assessed at the trapezius before and during immersion of the foot in a cold water bath (8°C). RESULTS In the migraine group (146.0 ± 79.1, mean ± SD), compared to healthy controls (248.0 ± 145.5, mean ± SD), significantly lower PPT (kilopascal) values were found (estimate = 124.28, 95% CI: 58.98, 189.59, p

Objective Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting. Methods This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days. Results Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). Conclusion Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.

OBJECTIVES: To characterize the short-term prognosis of a clinical population of pediatric and young adult patients with migraine and explore predictors of clinical worsening while in care. METHODS: This was a retrospective study of all migraine patients seen at the Cincinnati Children’s Hospital Headache Center from 09/01/2006 to 12/31/2017, who had at least one follow-up visit within 1–3 months of the index visit analyzed. Included data were: age, sex, race, primary ICHD diagnosis, chronic migraine, medication overuse, history of status migrainosus, BMI percentile, headache frequency, headache severity, PedMIDAS score, allodynia, preventive treatment type, lifestyle habits, disease duration, depressive and anxiety symptoms. Clinical worsening was defined as an increase of 4 or more headache days per month between the index visit and the follow-up visit. RESULTS: Data for 13,160 visit pairs (index and follow-up), from 5,316 patients were analyzed. Clinical worsening occurred in only 14.5% (1,908/13,160), whereas a reduction in headache frequency was observed in 56.8% of visit intervals (7,475/13,160), with 34.8% of the intervals (4,580/13,160) showing a reduction of 50% or greater. The change in headache frequency was minimal (increase in 0–3 headaches/month) in 28.7% of intervals (3,737/13,160). In the multivariable model, the odds of worsening were significantly higher with increasing age, female sex, chronic migraine, status migrainosus, depressive symptoms, higher PedMIDAS scores, and use of nutraceuticals, whereas the odds of worsening were lower for summer visits, caffeine drinkers, higher headache frequencies and use of pharmaceuticals. CONCLUSIONS: The majority of pediatric patients who receive multimodal interdisciplinary care for migraine improve over time. Our findings highlight a set of clinical features that may help in identifying specific factors that may contribute to an unfavorable short-term prognosis.

Purpose of review To highlight current evidence supporting the prescription of cognitive behavioral therapy (CBT) as part of first-line preventive treatment for children and adolescents with headache and discuss a research strategy aimed at: (1) understanding how and why CBT works, and (2) developing effective and efficient approaches for integrating CBT into headache specialty, neurology, and primary care settings. Recent findings Although preventive medications for pediatric headache and migraine are commonly prescribed, recent meta-analyses and an NIH-funded, multi-center clinical trial suggests that the effect of pill-taking therapies may be mostly due to a placebo effect. These findings have led to greater consideration of prescription of non-pharmacological therapies as first-line interventions (either alone or in combination with pill-based therapy). A literature that extends back to the 1980s and includes recent clinical trials and meta-analyses demonstrates that CBT decreases headache frequency and related disability in youth with headache and migraine and has a favorable benefit to risk profile with almost no negative side effects. Summary CBT has been repeatedly demonstrated as effective in treating pediatric headache and migraine. As such, it should be considered as part of first-line preventive treatment for pediatric headache (either alone or in combination with a pill-based therapy). We need to better understand how this therapy works and what makes it distinct (if anything) from the placebo effect. What we need to achieve is empirical support for efficient access to this evidence-based treatment and clarity on how to match the intensity of non-pharmacological intervention to the needs of our patients at the time they present for care.

OBJECTIVES To characterize a population of pediatric patients visiting an infusion center for acute migraine and determine predictors of first-line treatment success in this population. BACKGROUND Though migraine is common in the pediatric emergency department and specialized infusion centers, little is known about this patient population and whether or not clinical data can be used to predict treatment response. METHODS This was an observational study involving a retrospective analysis of data from visits to the Cincinnati Children's Hospital infusion center for treatment of an acute migraine. Data were extracted from a database and chart reviews were completed for missing or outlying data. Descriptive statistics were used to outline patient: sex, age, race, primary ICHD-III diagnosis, chronic migraine, medication overuse headache (MOH), headache frequency, month of treatment, headache severity, headache duration, use of acute medication at home in the past 24 hours and treatment received (metoclopramide vs prochlorperazine and dexamethasone vs no dexamethasone). The odds of success of first-line intervention were modeled using simple logistic regression with the above characteristics used as predictors. Predictors with a P value

OBJECTIVE: The goal of this study was to determine which cognitive behavioral therapy (CBT-HA) treatment components pediatric headache patient stakeholders would report to be most helpful and essential to reducing headache frequency and related disability in order to develop a streamlined, less burdensome treatment package that would be more accessible to patients and families. BACKGROUND: Pediatric migraine is a prevalent and disabling condition. CBT-HA has been shown to reduce headache frequency and related disability, but may not be readily available or accepted by many migraine sufferers due to treatment burden entailed. Research is needed to determine systematic ways of reducing barriers to CBT-HA. METHODS: Qualitative interviews were conducted with 10 patients and 9 of their parents who had undergone CBT-HA. Interviews were analyzed using an inductive thematic analysis approach based upon modified grounded theory. Patients were 13 to 17.5 years of age (M = 15.4, SD = 1.63) and had undergone CBT-HA approximately one to two years prior to participating in the study. RESULTS: Overall, patients and their parents reported that CBT-HA was helpful in reducing headache frequency and related disability. Although patients provided mixed reports on the effectiveness of different CBT-HA skills, the majority of patients indicated that the mind and body relaxation skills of CBT-HA (deep breathing, progressive muscle relaxation, and activity pacing in particular) were the most helpful and most frequently used skills. Patients and parents also generally reported that treatment was easy to learn, and noted at least some aspect of treatment was enjoyable. CONCLUSIONS: Results from these qualitative interviews indicate that mind and body CBT-HA relaxation skills emerged as popular and effective based on patient and parent report. Future research examining the effectiveness of streamlined pediatric migraine non-pharmacological interventions should include these patient-preferred skills.

OBJECTIVE To assess the impact of parental migraine on adolescents (aged 13-21 years) living within the parental home from the adolescent's perspective. BACKGROUND Family members are affected by their parent's migraine. We surveyed adolescents on the social, academic, and emotional effects of their parent's migraine. METHODS The Chronic Migraine Epidemiology and Outcomes (CaMEO) study was a longitudinal Web-based study with cross-sectional modules designed to assess migraine symptoms, severity, frequency, and disability; migraine-related consulting practices, healthcare utilization, medication use, comorbid health conditions, and family related burden associated with migraine. The Family Burden Module (adolescent version; FBM-A) from the CaMEO study assessed parents with migraine and adolescent household members (dyads). Adolescents ranged in age from 13-21 years and were living at home with their parent. The initial FBM-A survey included 52 items covering five domains, which was refined and reduced by confirmatory factor analysis to 36 items covering four domains. Depression (9-item Patient Health Questionnaire) and anxiety (7-item Generalized Anxiety Disorder scale) were assessed. Item responses were stratified by parent migraine status (episodic migraine [EM]

Objective The purpose of this investigation was to examine treatment adherence to medication and lifestyle recommendations among pediatric migraine patients using electronic monitoring systems. Background Nonadherence to medical treatment is a significant public health concern, and can result in poorer treatment outcomes, decreased cost-effectiveness of medical care, and increased morbidity. No studies have systematically examined adherence to medication and lifestyle recommendations in adolescents with migraine outside of a clinical trial. Methods Participants included 56 adolescents ages 11-17 who were presenting for clinical care. All were diagnosed with migraine with or without aura or chronic migraine and had at least 4 headache days per month. Medication adherence was objectively measured using electronic monitoring systems (Medication Event Monitoring Systems technology) and daily, prospective self-report via personal electronic devices. Adherence to lifestyle recommendations of regular exercise, eating, and fluid intake were also assessed using daily self-report on personal electronic devices. Results Electronic monitoring indicates that adolescents adhere to their medication 75% of the time, which was significantly higher than self-reported rates of medication adherence (64%). Use of electronic monitoring of medication detected rates of adherence that were significantly higher for participants taking once daily medication (85%) versus participants taking twice daily medication (59%). Average reported adherence to lifestyle recommendations of consistent noncaffeinated fluid intake (M = 5 cups per day) was below recommended levels of a minimum of 8 cups per day. Participants on average also reported skipping 1 meal per week despite recommendations of consistently eating three meals per day. Conclusions Results suggest that intervention focused on adherence to preventive treatments (such as medication) and lifestyle recommendations may provide more optimal outcomes for children and adolescents with migraine and their families. Once daily dosing of medication may be preferred to twice daily medication for increased medication adherence among children and adolescents.

Summary Background The purpose of this study was to evaluate the utility of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) with toddlers and preschool-aged children. Clinically relevant relations between health-related quality of life (HRQOL), stress, and mealtime behaviors have not been examined. It was hypothesized that problematic mealtime behaviors and increased stress would be negatively associated with HRQOL. Methods Parents of 73 children (2–6 years) with CF completed questionnaires assessing their children's generic (PedsQL) and CF-specific HRQOL, parenting and CF-specific stress, and mealtime behaviors. Results CFQ-R Physical, Eating, and Respiratory HRQOL subscales had acceptable to strong reliability (alphas = 0.73–0.86); other scales approached acceptable reliability. Lower CF-specific stress was associated with higher CFQ-R Eating HRQOL (B = −0.84; P

Objective The PedsQL rheumatology module is currently the only available measure of disease-specific quality of life for children and adolescents with juvenile fibromyalgia (FM), but limited information has been published about the psychometric properties of the instrument, specifically in juvenile FM. The objective of this study was to assess the reliability, validity, and sensitivity to change of the 5 scales (pain and hurt, daily activities, treatment, worry, and communication) of the patient and parent proxy versions of the PedsQL rheumatology module in the context of a randomized controlled trial in juvenile FM. Methods The entire PedsQL rheumatology module was administered as a supplementary outcome measure at baseline, posttreatment, and 6-month followup assessments of 114 children and adolescents with juvenile FM enrolled in a trial testing the efficacy of cognitive–behavioral therapy. Results Internal consistency reliabilities for the scales were adequate to strong (Cronbach's α = 0.68–0.86). Parent proxy and child reports on most scales (except for daily activities and communication) showed moderate correlations (Spearman's r = 0.33–0.45). Support for construct validity was found by comparing child and parent reports with other related measures of pain and functioning (visual analog scale pain ratings and the Functional Disability Inventory). Finally, sensitivity to change was demonstrated by significant changes in 4 of the 5 scales (excluding the daily activities scale) after treatment. Conclusion The PedsQL rheumatology module generally appears to have good utility for use in juvenile FM patients, but there are some caveats to the interpretation of specific scales in this population.

Background Migraine is one of the most common health problems for children and adolescents. If not successfully treated, it can impact patients and families with significant disability due to loss of school, work, and social function. When headaches become frequent, it is essential to try to prevent the headaches. For children and adolescents, this is guided by extrapolation from adult studies, a limited number of small studies in children and adolescents and practitioner preference. The aim of the Childhood and Adolescent Migraine Prevention (CHAMP) study is to determine the most effective preventive agent to use in children and adolescents. Methods CHAMP is a double-blinded, placebo-controlled, multicenter, comparative effectiveness study of amitriptyline and topiramate for the prevention of episodic and chronic migraine, designed to mirror real-world practice, sponsored by the US National Institute of Neurological Disorders and Stroke/National Institutes of Health (U01NS076788). The study will recruit 675 subjects between the ages of 8 and 17 years old, inclusive, who have migraine with or without aura or chronic migraine as defined by the International Classification of Headache Disorders, 2nd Edition, with at least 4 headaches in the 28 days prior to randomization. The subjects will be randomized in a 2:2:1 (amitriptyline: topiramate: placebo) ratio. Doses are weight based and will be slowly titrated over an 8-week period to a target dose of 1 mg/kg of amitriptyline and 2 mg/kg of topiramate. The primary outcome will be a 50% reduction in headache frequency between the 28-day baseline and the final 28 days of treatment (weeks 20-24). Conclusions The goal of the CHAMP study is to obtain level 1 evidence for the effectiveness of amitriptyline and topiramate in the prevention of migraine in children and adolescents. If this study proves to be positive, it will provide information to the practicing physician as how to best prevent migraine in children and adolescents and subsequently improve the disability and outcomes.

Juvenile fibromyalgia syndrome (FMS) is a chronic pain condition that is estimated to affect 2–7% of school-age children (1–3), primarily adolescent girls. As in adult fibromyalgia (FM), juvenile FMS is characterized by persistent and widespread musculoskeletal pain, sleep difficulty, fatigue, and mood disturbances (3). Patients with juvenile FMS experience substantial impairment in physical, school, social, and emotional functioning (4–6), and the majority of them continue to have ongoing symptoms and functional disability into late adolescence and early adulthood (7). Although progress has been made in the understanding and treatment of adult FM (8), there are few studies of juvenile FMS. Two recent meta-analytic reviews of cognitive–behavioral therapy (CBT) clinical trials for FM arrived at slightly different conclusions, with one supporting the effectiveness of CBT (9) and the other reporting no significant effect on pain and function (10). However, both reviews indicated significant improvement in coping and emphasized the need for higher quality trials of CBT. It is unclear whether findings from the 2 meta-analytic reviews, based mainly on adult FM patients, are applicable to pediatric patients. In a recent meta-analysis of psychological therapies for pediatric chronic pain (mostly headache and abdominal pain), Palermo et al (11) reported a large positive effect for pain reduction. It is possible that behavioral interventions found to be promising for adults with FM can be even more effective in juvenile FMS because they are implemented at an early age when pain coping and lifestyle factors are more malleable. There are no rigorously controlled studies of CBT for juvenile FMS at present. Early evidence for possible efficacy of CBT for improving function and decreasing pain and symptoms of depression in children and adolescents with juvenile FMS was shown in 2 small-scale studies (12,13). Unfortunately, neither study controlled for the nonspecific therapeutic effects of attention and support from health professionals, which by themselves could have resulted in improved outcomes. Therefore, the specific effects of CBT that go beyond providing emotional support and include intensive training in behavioral pain coping skills targeted at improving functioning by increasing patients' psychological coping and confidence in pain self-management skills have not yet been tested in a controlled study. We performed a multisite, randomized controlled trial in a sample of children and adolescents with juvenile FMS to rigorously assess the safety and efficacy of an 8-session, individually delivered CBT intervention compared to an 8-session supportive FM education program in reducing functional disability, pain severity, and depressive symptoms. The CBT treatment protocol was developmentally tailored for older school-age children and adolescents and included parental instruction to ensure family support for the behavioral interventions. We hypothesized that 1) CBT would be significantly more effective than FM education in reducing functional disability (primary outcome) in youth with juvenile FMS and 2) CBT would be significantly more effective than FM education in reducing pain severity and symptoms of depression (secondary outcomes). Unlike a “no-treatment” placebo control, the FM education condition was designed to be an “attention control” condition in which the nonspecific psychological benefits of the therapeutic relationship and educational information provided were expected to lead to some improvement in the short term (posttreatment assessment). However, we hypothesized that CBT would lead to sustained benefit and be demonstrably superior to FM education in reducing disability, pain, and symptoms of depression 6 months after the end of active treatment (end-of-study assessment). Selection of the outcome domains of function, pain severity, and symptoms of depression was consistent with the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT) guidelines for measurement of outcomes in clinical trials of pediatric chronic pain (14). Functional disability was selected as the primary outcome because the goal of CBT is to reduce pain-related disability by teaching patients both coping and self-management behaviors (and providing parental guidance in behavior management) to improve function, while secondarily reducing pain severity and symptoms of depression. Other outcomes of interest such as tender point sensitivity, health-related quality of life (HRQOL), sleep quality, and physician's global assessment were also measured at each assessment.

Aims: This study examined associations between mealtime family functioning, dietary adherence and glycaemic control in young children with type 1 diabetes mellitus (T1DM). We hypothesised that poorer family functioning would correlate with poorer dietary adherence and glycaemic control. Methods: Thirty-five families of children (M = 5.6 1.5 years) with T1DM had meals videotaped in their home, which were coded for family functioning according to the McMaster Interaction Coding System. Children’s dietary adherence was assessed according to deviations from the prescribed number of carbohydrate units per meal and recommended carbohydrate intake levels per day. Glycaemic control was measured via 14 days of self-monitoring of blood glucose levels. Results: Findings demonstrated significant negative associations between children’s dietary adherence and two dimensions of family functioning: Task Accomplishment (r =- 0.43, P = 0.03) and Behavioral Control (r =- 0.54, P = 0.00). Affect Management correlated negatively with the percent of blood glucose levels below the normal range (r =- 0.33, P = 0.05). Eleven families (31%) of young children with type 1 diabetes demonstrated mealtime family functioning in the unhealthy range. Conclusions: This was the first study to examine the relationship between mealtime family functioning and children’s dietary adherence and glycaemic control in families of young children with T1DM. Previous research has found mealtime family functioning to be impaired in families of young children with T1DM when compared with families of children without diabetes. Research is needed to determine if family functioning and dietary adherence can be improved via specific family-based behavioural training around mealtimes.

Objective.— To characterize menstrually associated headaches and migraine in adolescent girls and identify any developmental and pubertal changes. Background.— Headache and migraine is a common problem in adolescents with a transition to adult patterns. One pattern of adult migraine is the menstrual association in a significant number of women. Methods.— A retrospective analysis was performed of characteristics of adolescent's headaches including association with menstrual pattern. A detailed analysis of the patient- and parent-reported headache characteristics and patterns of longitudinal change with development and puberty was reviewed, including timing of headache with age and menstrual period and progression of these events over the adolescence. Results.— Of the 896 girls between 9 and 18 years old reviewed at initial evaluation, 331 (50.3% of menarchal girls and 36.9% of all girls) report experiencing headaches with their menstrual period. Of those reporting a menstrual pattern, 63.6% reported migraines starting between day −2 and +3 of their menstrual period start. Girls with menstrual migraine reported increased associated symptoms compared with girls without menstrual migraine. There was no difference in disability between girls with a menstrual pattern and those without a menstrual pattern (t = 1.64; P = .10). Additionally, 160 girls reported a monthly pattern to their headaches prior to beginning menstruation, suggestive of a menstrually related migraine pattern prior to menstruation. Conclusions.— The pattern of menstrual association begins to become apparent during adolescence. Once the menstrual pattern has developed, this association is stable. Early identification of this pattern has potential long-term benefit for improved lifelong outcome.

Objective.— To examine the prevalence of obesity, the relationship between weight compared with headache frequency and disability, and effect of weight change on headache outcomes within a pediatric headache population. Background.— Headache and obesity are both common conditions in children and adults. Research in adults has suggested a relationship between the 2 conditions. This relationship has not yet been explored within a pediatric population. The effect of obesity and weight change on headache outcomes may have important implications for clinical care. Method.— Data on height, weight, age, and gender, as well as headache frequency and disability, were collected on 913 consecutive patients at 7 pediatric headache centers, the body mass index (BMI) calculated and the BMI percentile determined. The same data were collected on patients seen at 3- (n = 213) and 6-month (n = 174) follow-up for comparative analysis. Results.— The prevalence of overweight patients at initial visit did not significantly differ from the general pediatric population. BMI percentile was significantly correlated with headache frequency and disability at initial visit, although the correlations were relatively small. For children who were obese or at risk for overweight as initial visit, change in BMI was significantly positively correlated with change in headache frequency at 3- and 6-month follow-up. Conclusions.— Obesity is associated with headache frequency and disability in the pediatric headache population. For children who are overweight, weight loss can contribute to a reduction in headaches over time. Clinicians should consider child weight status in providing care for pediatric headache.

Objective: To test the hypothesis that low-income African-American preschool children would have a higher BMI if their mothers reported greater “restriction” and “control” in feeding and if mothers reported that children showed greater “food responsiveness” and “desire to drink.” In addition, to test whether higher maternal “pressure to eat” would be associated with lower child BMI. Research Methods and Procedures: A questionnaire was completed by 296 low-income African-American mothers of preschool children. It assessed three constructs on maternal feeding strategies (“restriction,” “pressure to eat,” and “control”) and two on child eating behaviors (“food responsiveness” and “desire to drink”). Children's BMI was measured, and mothers’ BMI was self-reported. Results: The mean (standard deviation) BMI z-score of the children was 0.34 (1.5), and 44% of the mothers were obese (BMI ≥30 kg/m2). Only maternal “pressure to eat” had a significant overall association with child BMI z-score (r = −0.16, p < 0.01). Both maternal “restriction” and “control” were positively associated with children's BMI z-score in the case of obese mothers (r = 0.20, p = 0.03 and r = 0.24, p = 0.007, respectively), but this was not so in the case of non-obese mothers (r = −0.16, p = 0.05 and r = −0.07, p = 0.39, respectively). Discussion: Among low-income African Americans, the positive association between maternal restriction and control in feeding and their preschoolers’ BMI was limited to obese mothers. Relations between parent feeding strategies and child weight status in this population may differ on the basis of maternal weight status.

Objective.—To evaluate the sensitivity of the new International Classification of Headache Disorders-2nd edition (ICHD-II) criteria in the diagnosis of childhood migraine and to propose specific criteria for the diagnosis of childhood migraine. Background.—In 2004, ICHD-II was adopted by the International Headache Society. The prior version had been criticized for its lack of sensitivity in diagnosing childhood headaches. ICHD-II is felt to be an improvement as it provides for some differences between pediatric and adult migraine diagnosis in its footnotes, however, has yet to be validated. Clinically, it is the impression of many pediatric headache specialists that children's migraines are of shorter duration, tend to be bilateral rather than unilateral, and that children more often report either photophobia or phonophobia, rather than both. Methods.—The characteristics of headache in 260 patients, ages 18 and under, clinically diagnosed with migraine at two large pediatric headache centers were compiled using standard intake questionnaires. Inter-rater reliability in clinical diagnosis was determined by consensus of the clinical diagnosis. These data were analyzed applying the International Classification of Headache Disorders-1st edition (ICHD-I) and ICHD-II criteria for migraine to determine sensitivity of migraine diagnosis in comparison with clinical impression. Each headache characteristic in ICHD-II was analyzed individually to determine its effect on sensitivity of diagnosis. Results.—183/260 patients (70.4%) met ICHD-I criteria. 161/260 patients (61.9%) met the ICHD-II criteria with a 4- to 72-hour range. When the footnoted allowance of ICHD-II for short duration (2 hours) was utilized, 187/260 patients (71.9%) met criteria, while this improved to 192/260 patients (73.9%) with 1-hour duration. If duration was excluded, 210/260 patients (80.8%) met criteria. The most common reasons for patients not meeting the standard criteria were the requirement of unilateral location, headache duration and number of associated symptoms. Based on these observations, modified criteria were empirically derived and the sensitivity increased to 84.4%. Data were reanalyzed using the criteria of focal head pain, either bilateral or unilateral, shortened duration, and modified associated symptoms, which resulted in an improved sensitivity in migraine diagnosis of 84.4%. Conclusions.—Modification of ICHD-II criteria to include bilateral headache, headache duration of 1 to 72 hours, and nausea and/or vomiting plus two of five other associated symptoms (photophobia, phonophobia, difficulty thinking, lightheadedness, or fatigue), in addition to the usual description of moderate to severe pain of a throbbing or pulsating nature worsening or limiting physical activity, improved sensitivity of migraine diagnosis to 84.4%.

Objective.—To assess the long-term effectiveness and outcome of multidisciplinary treatment of childhood headaches 1, 2, and 5 years after initial treatment. Background.—Headaches are a common problem for children and adolescents and for many patients continue into adulthood. Outcome research for pediatric migraine headaches is limited, thus restricting knowledge of the effectiveness of long-term management and outcome. Methods.—Headache characteristics were assessed at the initial visit and were reevaluated 1, 2, and 5 years later in independent sub-groups of consecutive patients. These characteristics included headache frequency, severity, average duration, school absences, and overall perceived response to treatment. Results.—At 1 year, 96 patients were evaluated (mean age = 11.0 ± 3.4, 59% females), 69 patients at 2 years (mean age = 10.6 ± 3.4, 48% females), and 32 at 5 years (mean age = 10.5 ± 3.9, 66% females). The headaches were reported as better in 94% at 1 year, 85% at 2 years, and 94% at 5 years. The initial frequency was at 13.4 ± 10.8 headaches per month, 4.9 ± 7.0 at 1 year (P < .001), 4.7 ± 7.6 at 2 years (P < .001), and 4.5 ± 7.5 at 5 years (P < .001). The severity decreased from 6.8 ± 1.8 to 5.1 ± 2.3 at 1 year (P < .001), to 5.0 ± 2.4 at 2 years (P < .001), and to 4.6 ± 2.5 at 5 years (P < .01). The school days missed per month showed a marked decrease from 4.5 ± 9.5 at initial visit to 1.55 ± 2.8 at 5 years (P < .001). Patients that were only seen at their initial visit and did not choose to return for follow-up had less frequent and shorter duration headaches on initial visit when compared with the rest of the sample and continued to be doing well at the 1-, 2-, and 5-year assessments. Conclusions.—Multidisciplinary treatment was found to be effective for children and adolescents with improvement of multiple outcome variants of pediatric migraine care, including frequency, severity, and school days missed. Patients who did not return to follow-up evaluation were more likely to have less frequent and shorter duration headaches at initial presentation. Regular follow-up care is needed for those children with more severe initial headache presentation.

Headache occurs across the lifespan, but limited attention has been devoted to children and adolescents. This article discusses pertinent methodological considerations when conducting behavioral research with pediatric populations. Issues needing special consideration when working with children and adolescents involve ethics, sample characterization, headache diagnosis, treatment administration, and outcome measurement. Available literature is reviewed and specific recommendations are offered when possible.

Trials that compare drug and behavior therapies or evaluate combination therapy raise special methodological issues. This article reviews these methodological issues and, where possible, offers guidelines for addressing them. Sources of bias in the selection and recruitment of participants and in the measurement of treatment outcomes are discussed. In addition, methodological problems presented by the differing structures of behavior and drug therapy, by confounding variables, such as allegiance effects, differential expectations and preferences for drug or behavior therapy, and differential adherence with drug or behavior therapy also are reviewed. Issues in the selection of appropriate control groups are also discussed.

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.

Objectives To compare the food group variety and nutritional adequacy of the diet between toddlers with cystic fibrosis (CF) and age-matched controls. Subjects A clinical sample of 22 toddlers with CF (mean age = 21.3 ± 7.2 months) matched to a community sample of 22 healthy peers. Main outcome measures The variety index for toddlers (VIT) and the mean adequacy ratio (MAR). Results Fruit group scores were highest for children with CF (0.95 ± 0.13; possible range 0.00–1.00), and dairy group scores were highest for controls (0.90 ± 0.18). All children earned the lowest scores for vegetables (CF: 0.15 ± 0.12; controls: 0.26 ± 0.22). No significant differences were found when comparing VIT and MAR scores by sample (P > 0.05). A moderate positive relationship was found between total VIT scores and MAR scores for all children (r = 0.38, P

Background.—Migraine headache is common and has multiple etiologies. A number of mitochondrial anomalies have been described for migraine, and mitochondrial dysfunction has been implicated as one potential pathophysiological mechanism. Carnitine is used by mitochondria for fatty acid transportation; its deficiency, however, has not been implicated in migraine pathophysiology. Methods and Results.—Two adolescent girls presented to the Headache Center at Cincinnati Children's Hospital Medical Center with frequent headaches and were diagnosed with migraine by the International Headache Society (IHS) criteria. Both girls had a history of recurrent fatigue, muscle cramps, and multiple side effects from their prophylactic treatment. Carnitine levels were measured and found to be low. Carnitine supplementation was initiated. Both patients had a reduction in headache frequency, as well as an improvement in their associated symptoms and other complaints. A skin and muscle biopsy obtained from one patient revealed a partial carnitine palmityltransferase II deficiency in the muscle only. Conclusion.—Carnitine palmityltransferase II deficiency may represent another etiology for migraine headache, and may be useful in further defining the pathophysiology of migraine. When properly recognized, supplementation with carnitine may improve the outcome of the migraine as well as the carnitine-associated symptoms.

BACKGROUND Migraine is a significant problem for many children. Topiramate has been suggested to be effective for the prophylaxis of migraine in adults, but has not yet been examined in children. The drug has been demonstrated to be safe and effective for childhood seizure disorders. The objective of this study was to demonstrate the safety and efficacy of topiramate for the prevention of pediatric migraine. METHODS Children with frequent migraine were prescribed topiramate for headache prevention. Dosages, serum levels, and Serum Glutamic Oxalacetic Transaminase (SGOT) levels were monitored. Changes in frequency, severity, and duration of headaches were recorded and changes in headache-related disability using PedMIDAS also were measured. RESULTS Ninety-seven children were treated with topiramate, and 75 were reevaluated 88.7 +/- 35.7 days later, 41 were seen at a second follow-up, and 17 were seen at a third follow-up evaluation. The daily dose reached at second evaluation was 84.0 +/- 38.6 mg/day or 1.42 +/- 0.74 mg/kg/day. This corresponded to a mean serum level of 2.8 +/- 1.6 micro g/mL. The mean headache frequency was reduced from 16.5 +/- 10.0 to 11.6 +/- 10.2 days per month (P

Three mildly malnourished children with cystic fibrosis and their parents participated in a behavioral group-treatment program that focused on promoting and maintaining increased calorie consumption. Treatment included nutritional education, gradually increasing calorie goals, contingency management, and relaxation training, and was evaluated in a multiple baseline design across four meals. Children's calorie intake increased across meals, and total calorie intake was 32% to 60% above baseline at posttreatment. Increased calorie consumption was maintained at the 96-week follow-up (2 years posttreatment). The children's growth rates in weight and height were greater during the 2 years following treatment than the year prior to treatment. Increases in pace of eating and calories consumed per minute were also observed 1 year posttreatment. These findings replicated and extended earlier research supporting the efficacy of behavioral intervention in the treatment of malnutrition in children with cystic fibrosis.

An evidence-based, biopsychosocial approach to the care of pediatric patients who present with the complaint of headache is recommended. This approach informs diagnosis and management decisions, is critical for maximizing adherence to the prescribed headache treatment regimen, and incorporates assessment of the impact of headache on a child/adolescent's quality of life, disability, and emotional functioning. Very often, successful treatment of headache leads to improvements in disability and emotional functioning. When this is not the case, or when the work-up shows that comorbid headache and psychiatric disorders are present for a patient, a more comprehensive treatment approach that includes the active collaboration of pediatric specialists in headache care and mental health care is warranted.