Mobile technology for obesity prevention: a randomized pilot study in racial- and ethnic-minority girls.

BACKGROUND: Mobile technologies have wide-scale reach and disseminability, but no known studies have examined mobile technologies as a stand-alone tool to improve obesity-related behaviors of at-risk youth. PURPOSE: To test a 12-week mobile technology intervention for use and estimate effect sizes for a fully powered trial. METHODS: Fifty-one low-income, racial/ethnic-minority girls aged 9-14 years were randomized to a mobile technology (n=26) or control (n=25) condition. Both conditions lasted 12 weeks and targeted fruits/vegetables (FVs; Weeks 1-4); sugar-sweetened beverages (SSBs; Weeks 5-8), and screen time (Weeks 9-12). The mobile intervention prompted real-time goal setting and self-monitoring and provided tips, feedback, and positive reinforcement related to the target behaviors. Controls received the same content in a written manual but no prompting. Outcomes included device utilization and effect size estimates of FVs, SSBs, screen time, and BMI. Data were collected and analyzed in 2011-2012. RESULTS: Mobile technology girls used the program on 63% of days and exhibited trends toward increased FVs (+0.88, p=0.08) and decreased SSBs (-0.33, p=0.09). The adjusted difference between groups of 1.0 servings of FVs (p=0.13) and 0.35 servings of SSBs (p=0.25) indicated small to moderate effects of the intervention (Cohen's d=0.44 and -0.34, respectively). No differences were observed for screen time or BMI. CONCLUSIONS: A stand-alone mobile app may produce small to moderate effects for FVs and SSBs. Given the extensive reach of mobile devices, this pilot study demonstrates the need for larger-scale testing of similar programs to address obesity-related behaviors in high-risk youth.

Headstrong intervention for pediatric migraine headache: a randomized clinical trial.

BACKGROUND: The purpose of this study was to evaluate the efficacy of a self-guided CD-ROM program ("Headstrong") containing cognitive-behavioral self-management strategies versus an educational CD-ROM program for treating headaches, headache-related disability, and quality of life. METHODS: Participants were 35 children ages 7-12 years with migraine recruited from one university medical center and two children's hospital headache clinics. Participants were randomly assigned to complete the Headstrong or educational control CD-ROM program over a 4-week period. Data on headache frequency, duration, and severity, migraine-related disability, and quality of life (QOL) were obtained at baseline, post-intervention, and 3-months post-intervention. RESULTS: At post-intervention, Headstrong resulted in lower severity (on a 10-point scale) than the control group by child report (5.06 ± 1.50 SD vs. 6.25 ± 1.92 SD, p = 0.03, ES = 0.7). At 3-months post-intervention, parents reported less migraine-related disability (on the PedMIDAS) in the Headstrong group compared to the control group (1.36 ± 2.06 SD vs. 5.18 ± 6.40 SD; p = 0.04, ES = 0.8). There were no other group differences at post treatment or at 3-months post-intervention. CONCLUSIONS: When compared to an educational control, Headstrong resulted in lower pain severity at post-treatment and less migraine-related disability at 3-months post-intervention, by child and parent report respectively. Headache frequency and quality of life did not change more for Headstrong versus control. Additional research is needed on the Headstrong Program to increase its efficacy and to test it with a larger sample recruited from multiple centers simultaneously.

Massage on experimental pain in healthy females: a randomized controlled trial.

This randomized controlled study evaluated the effect of massage on affect, relaxation, and experimental pain induced by electrical stimulation. Participants were 96 healthy women (M age = 20.13 ± 5.93 years; 84.4% White) randomly assigned to a 15-minute no-treatment control, guided imagery, massage or massage plus guided imagery condition. Multilevel piecewise modeling revealed no group differences in pain intensity, threshold, or tolerance. The two massage conditions generally reported decreased pain unpleasantness, lower unpleasant affect, maintenance of pleasant affect, and increased relaxation compared to the no-treatment condition. The results suggest that massage may alter immediate affective qualities in the context of pain.

Relationship between daily mood and migraine in children.

BACKGROUND: Retrospective and cross-sectional studies have suggested a bidirectional relationship between migraine and mood disturbance. OBJECTIVE: The present prospective daily diary study examined the prevalence and temporal associations between migraine and daily mood, mood and next-day headache, and headache and next-day mood. METHODS: Sixty-nine children (50 females, 19 males) between the ages of 7 and 12 years and their parents attending neurology clinic appointments and having a diagnosis of migraine as defined by International Headache Classification 2nd edition criteria completed measures on the quality of life, headache disability, child emotions, and child behaviors. Children and parents then recorded children's headache occurrence, headache duration, headache severity, mood, daily hassles, and medication use on paper diaries once a day for 2 consecutive weeks. "Mood" was defined using the Facial Affective Scale, which is a visual representation of negative and positive affect. Data were analyzed using multilevel models. RESULTS: Controlling for age, sex, quality of life, headache disability, and medication use, worse mood was associated with same-day occurrence, longer duration, and more severe headache in both child and parent report. Today's mood was not consistently associated with next-day headache, and today's headache was not associated with next-day mood in either child or parent report. CONCLUSIONS: Results of this study lend support to a complex relationship between mood and headache in children with migraine. More research is needed to further elucidate the temporal nature of this relationship within a given day and over an extended period of time.

The program evaluation of services in a primary care clinic: attaining a medical home.

A program evaluation of a pediatric primary care training clinic was conducted using the criteria of a "medical home" set forth by the American Academy of Pediatrics (AAP). A total of 107 parents completed questionnaires regarding demographics, satisfaction with care, and questions related to the definition of medical home. Medical providers completed questionnaires regarding demographics, job satisfaction, and community resources. Parents reported acceptable levels of satisfaction with the quality of care provided, and the essential parts of the medical home definition were met. There were several areas that were designated as having room for improvement, including shortening clinic wait times and instructing the medical providers to be more sensitive to cultural differences in beliefs about health and wellness. The concepts of medical home set forth by the AAP are attainable for pediatric primary care clinics, but routine evaluations may be needed to ensure that goals continue to be met.

Attrition in randomized controlled trials for pediatric chronic conditions.

OBJECTIVE: To examine attrition variables in randomized controlled trials of cognitive behavioral interventions for children with chronic illnesses. METHODS: We examined attrition rates reported on 40 randomized cognitive behavioral interventions published in six pediatric research journals, during the years 2002-2007. Intervention focus was limited to children with a chronic medical condition, such as asthma, obesity, arthritis, diabetes, cancer, sickle cell disease, and cystic fibrosis. RESULTS: Mean rate of enrollment refusal was 37% (range 0-75%). Mean attrition rate was 20% (range 0-54%) for initial follow-up and 32% (range 0-59%) for extended follow-up. Of the reviewed articles, 40% included a CONSORT diagram. CONCLUSIONS: Strategies that can be used to limit attrition include tailoring recruitment to the study population, providing personalized feedback, maintaining consistent study procedures, providing incentives, and using intensive tracking measures. There is a need for standardized definitions and reporting of attrition rates in randomized cognitive behavioral intervention studies.

Evidence-based assessment of adherence to medical treatments in pediatric psychology.

OBJECTIVES: Adherence to medical regimens for children and adolescents with chronic conditions is generally below 50% and is considered the single, greatest cause of treatment failure. As the prevalence of chronic illnesses in pediatric populations increases and awareness of the negative consequences of poor adherence become clearer, the need for reliable and valid measures of adherence has grown. METHODS: This review evaluated empirical evidence for 18 measures utilizing three assessment methods: (a) self-report or structured interviews, (b) daily diary methods, and (c) electronic monitors. RESULTS: Ten measures met the "well-established" evidence-based (EBA) criteria. CONCLUSIONS: Several recommendations for improving adherence assessment were made. In particular, consideration should be given to the use of innovative technologies that provide a window into the "real time" behaviors of patients and families. Providing written treatment plans, identifying barriers to good adherence, and examining racial and ethnic differences in attitudes, beliefs and behaviors affecting adherence were strongly recommended.

Improving adherence to medical regimens for juvenile rheumatoid arthritis.

Poor adherence to medical regimens can compromise the efficacy of treatments for children and adolescents with juvenile rheumatoid arthritis (JRA). The purpose of this review is to describe medical regimens for the treatment of JRA and the rates of adherence to these regimens. We also summarize and critically the few research studies aimed at improving adherence to regimens for JRA. Finally, we summarize strategies for enhancing adherence in clinical practice.

Headstrong: a pilot study of a CD-ROM intervention for recurrent pediatric headache.

OBJECTIVES: To empirically evaluate a minimal therapist contact CD-ROM pain management program for recurrent pediatric headache developed as part of this study. METHODS: Participants were 37 children aged 7-12 attending a pediatric neurology clinic for evaluation of recurrent headache. Children who were randomly assigned to the treatment group worked through the CD-ROM program on home computers for 4 weeks following baseline assessment, whereas those assigned to the wait-list group continued following the prescriptions of their neurologist. Data on daily headache activity and headache-related disability were collected at baseline and up to 3 months after treatment. RESULTS: Children who received the adjunctive CD-ROM program had significant improvements in headache activity above and beyond those in the control group. Results provide initial support for the utility of adding an adjunctive CD-ROM psychological intervention to standard medical care for recurrent pediatric headache and potentially other chronic pain conditions in children.

Management of adherence and chronic rheumatic disease in children and adolescents.

Medical treatment regimens for pediatric rheumatic diseases are complex, have delayed beneficial effects, and require consistent adherence over a long period of time. All of these factors place patients at risk for non-adherence that can compromise the benefits of treatment and the long-term health and quality of life for patients. This chapter provides a definition of adherence and reviews the prevalence of non-adherence to regimens for pediatric rheumatic diseases. It also describes various methods for assessing adherence, including assays, observation, electronic monitoring, pill counts, and provider or patient ratings of adherence. Studies which identify risk factors for non-adherence are also reviewed, with suggestions on how these risk factors might be addressed. The final section reviews the few studies that have reported on efforts to improve adherence to regimens for pediatric rheumatic diseases and offers strategies for providers to promote adherence with their patients.

Assessing health-related quality of life in children with recurrent headache: reliability and validity of the PedsQLTM 4.0 in a pediatric headache sample.

OBJECTIVE: To evaluate the reliability and validity of a commonly used measure of health-related quality of life (HRQOL), the Pediatric Quality of Life Inventory (PedsQL 4.0), in a sample of children with a recurrent headache syndrome. METHODS: Participants were 40 children aged 7-12 who completed measures of HRQOL, headache-related disability, and headache activity during a baseline period and following a self-directed cognitive-behavioral intervention. RESULTS: The data are supportive of the reliability (internal consistency and test-retest) and validity (criterion related, convergent, known-groups, and responsiveness to intervention) of the PedsQL 4.0 within a pediatric headache sample. CONCLUSIONS: We conclude that the PedsQL 4.0 is a reliable and valid measure of HRQOL in children with recurrent headache and captures important information not routinely evaluated in chronic pain populations.

Electronically monitored adherence to medications by newly diagnosed patients with juvenile rheumatoid arthritis.

OBJECTIVE: To describe patterns of adherence to nonsteroidal antiinflammatory drugs (NSAIDs) in newly diagnosed patients with juvenile rheumatoid arthritis (JRA), and to examine demographic and disease-related variables as potential predictors of adherence. METHODS: Adherence to NSAIDs was monitored in 48 children with JRA (mean age 8.6 years) over 28 consecutive days using an electronic monitoring device. Measures of disease activity (active joint counts, morning stiffness) and demographics (age, sex, ethnicity, socioeconomic status) were also obtained. RESULTS: Using an 80% adherence cut point, 25 (52%) patients were classified as adherent and 23 (48%) as nonadherent. There was considerable variability across patients, with full adherence (taking all doses on time) ranging from 0 to 100% of the monitored days. Logistic regression showed that active joint count and socioeconomic status were the only significant predictors. Both were positively related to adherence. The model correctly classified 70.5% of patients as either adherent or nonadherent (Cox and Snell R(2) = 0.295, P = 0.0005). CONCLUSION: Children newly diagnosed with JRA are more likely to adhere to an NSAID regimen if they have a greater number of active joints or their families have higher socioeconomic status. The former finding suggests that children's adherence is symptom-driven, while the latter suggests that families of lower socioeconomic status deserve special attention to address adherence issues.

The PedsQL in pediatric asthma: reliability and validity of the Pediatric Quality of Life Inventory generic core scales and asthma module.

The PedsQL is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2-18. The PedsQL 4.0 Generic Core Scales were developed to be integrated with the PedsQL Disease-Specific Modules. The PedsQL3.0 Asthma Module was designed to measure pediatric asthma-specific HRQOL. The PedsQL was administered to 529 families. Internal consistency reliability was demonstrated for the PedsQL 4.0 Total Score (alpha = 0.90 child, 0.91 parent report) and Asthma Module (average alpha = 0.71 child, 0.86 parent report). The PedsQL 4.0 distinguished between healthy children and children with asthma. The validity of the PedsQL Asthma Module was demonstrated through intercorrelations with a previously standardized asthma disease- specific instrument. Responsiveness was demonstrated through patient change over time as a result of clinical intervention. The results demonstrate the reliability, validity, and responsiveness of the PedsQL required for an outcome measure in pediatric asthma clinical trials and research.

Prevention of nonadherence to nonsteroidal anti-inflammatory medications for newly diagnosed patients with juvenile rheumatoid arthritis.

Adherence to medications for chronic pediatric diseases decreases overtime. This randomized controlled trial evaluated a clinic-based, nurse-administered educational and behavioral intervention to prevent the anticipated drop in adherence to nonsteroidal medications among newly diagnosed patients with juvenile rheumatoid arthritis. Thirty-four participants completed the study (mean age = 8.44 years, SD = 3.96), including 19 in the experimental group and 15 in the standard-treatment (education) control group. There were significant group and Group x Time effects for adherence (assessed with an electronic monitor over a 13-month period) favoring the experimental group. In contrast, the groups did not differ significantly in disease activity or functional limitations. Factors that may have prevented detection of differences in these health parameters are dicussed.

Daily hassles and social support as predictors of adjustment in children with pediatric rheumatic disease.

OBJECTIVE: To test hypotheses that social support moderates the effects of microstressors on the psychosocial adjustment of children with pediatric rheumatic diseases (PRDs) and that among multiple sources of support, classmate and parent support are significant predictors of adjustment, after controlling for demographic and disease severity variables. METHODS: Children with PRDs (N = 160 children; 8-17 years) were recruited from three pediatric rheumatology centers and completed measures of daily hassles, social support, depressive symptoms, and state and trait anxiety; their parents completed measures of internalizing and externalizing behaviors. RESULTS: Fewer daily hassles and higher social support predicted fewer adjustment problems. Among the sources of support, classmate and parent support were significant predictors. Tests for moderation were significant only for a Hassles x Classmate Support interaction in the prediction of depression. A plot of the interaction between hassles and classmate support showed that children with high classmate support had lower levels of depression than children with low classmate support under high or low levels of daily hassles. Furthermore, children with high classmate support had lower levels of depression under conditions of low versus high daily hassles. DISCUSSION: Results are consistent with a main effect rather than buffering model for social support. CONCLUSIONS: Interventions should focus on management of daily hassles and increasing social support for children with PRDs.