Motivating Latino caregivers of children with asthma to quit smoking: A randomized trial.

Objective: Secondhand smoke exposure is associated with asthma onset and exacerbation. Latino children have higher rates of asthma morbidity than other groups. The current study compared the effectiveness of a newly developed smoking cessation treatment with existing clinical guidelines for smoking cessation. Method: Latino caregivers who smoked (N = 133; 72.9% female; mean age = 36.8 years) and had a child with asthma were randomly assigned to receive 1 of 2 smoking cessation counseling interventions during a home-based asthma program: (a) behavioral action model (BAM; modeled on clinical guidelines for smoking cessation) or (b) precaution adoption model (PAM; feedback on the caregiver’s carbon monoxide level and child’s secondhand smoke exposure using Motivational Interviewing). Counseling was delivered by a bilingual Latina health educator, and the content was tailored to Latino values and culture. It was not necessary for smokers to want to quit smoking to participate. Smoking cessation was biochemically verified and secondhand smoke exposure was objectively measured through passive nicotine monitors. Results: Intent-to-treat analyses showed that 20.5% of participants in the PAM condition and 9.1% of those in the BAM condition were continuously abstinent at 2 months posttreatment (OR = 2.54; 95% CI = 0.91–7.10), whereas 19.1% of participants in the PAM condition and 12.3% of those in BAM condition were continuously abstinent at 3 months posttreatment (OR = 1.68; 95% CI = 0.64–4.37). Secondhand smoke exposure decreased only in the BAM condition (p p     

A randomized crossover trial of levodopa in congestive heart failure

BACKGROUND: The short- and long-term effects of levodopa (L-dopa), an oral dopaminergic prodrug, were assessed in patients with severe left ventricular dysfunction. METHODS AND RESULTS: Initially, 26 patients were included in the study group. After clinical, radiographic, and radionuclide examination, each patient underwent right heart catheterization (Swan-Ganz thermodilution catheter). Plasma noradrenaline levels were measured. In two patients, a favorable hemodynamic response to L-dopa was not observed, another two required permanent pacemaker implantation. These four patients were excluded from the study. Two patients required permanent pacemaker implantation. The remaining 22 patients with favorable hemodynamic response to L-dopa (increase in cardiac index, stroke volume index, reduction in total systemic resistance) were randomized in a nonblinded fashion to the conventional (11 patients) or conventional plus L-dopa (11 patients) treatment groups. During the study period, two patients, one from each group, died. They were excluded from the analysis. The final analyzed study group consisted of 20 men, aged 33-69, in New York Heart Association functional class IV (9 patients) and III (11 patients). The cause of congestive heart failure was primary dilated cardiomyopathy in 11 patients and ischemic heart disease in 9 patients. After 3 months' treatment, all patients were crossed over. Clinical, radiographic, radionuclide, and hemodynamic evaluation was repeated at the end of the 3-month treatment period. After 3 months of therapy with L-dopa in each group (covariance analysis), there was improvement in clinical, radiographic (relative heart volume, -128 mL/m2), radionuclide (left ventricular ejection fraction, +4.6; right ventricular ejection fraction, +4.8%), hemodynamic (mean pulmonary wedge pressure, -8 mmHg; total systemic resistance, -1.8 Wu; total pulmonary resistance, -3.5 Wu), and neurohumoral (noradrenaline, -218 pg/mL) measures. CONCLUSIONS: The addition of L-dopa to conventional therapy has beneficial short- and long-term effects in patients with severe left ventricular dysfunction.     

Six-week trial of nebulized flunisolide nasal spray: efficacy in young children with moderately severe asthma

This study evaluated the clinical efficacy of nebulized flunisolide nasal solution (Nasalide) in young children with moderately severe asthma. Twenty-two asthmatic children, ages 12-72 months, completed this double-blind placebo-controlled study. After a 6-week observation period, 18 patients were paired according to asthma severity. One child from each pair was randomized to flunisolide, the other to placebo; 4 patients were independently randomized. Placebo or drug was then administered for 6 weeks. Throughout the study, symptoms, drug usage, and analog scales reflecting asthma severity and family disruption were recorded in a diary. Multiple regression analysis was used to compare the flunisolide and placebo groups in regard to the amount of improvement demonstrated from the observation to the active periods of the study. Analog scores of asthma severity and family disruption, albuterol aerosol use, and systemic corticosteroid use fell roughly 40% from baseline in the flunisolide group. This improvement was significant compared to the placebo group. We conclude that 1 ml (250 microg) of nebulized flunisolide nasal spray solution, administered three times daily, reduced the severity of asthma symptoms, and the need for both albuterol aerosol and systemic corticosteroid therapy in young children with moderately severe asthma during a 6-week trial. Longer term studies are warranted.     

A randomized controlled trial comparing two vocational models for persons with severe mental illness.

The authors compared 2 approaches to vocational rehabilitation for individuals with severe mental illness: the individual placement and support (IPS) model of supported employment and the diversified placement approach (DPA), which emphasizes work readiness and offers a range of vocational options, including agency-run businesses and agency-contracted placements with community employers. In all, 187 unemployed participants with severe mental illness were randomly assigned to IPS or DPA. Over 2 years, IPS had significantly better competitive employment outcomes than DPA. Competitive employment rates over the 2-year follow-up were 75.0% for IPS and 33.7% for DPA. However, IPS and DPA did not differ on paid employment outcomes. The authors conclude that IPS is more effective than DPA in achieving competitive employment, but not paid employment. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Treating anxiety disorders in children with group cognitive-behavioral therapy: A randomized clinical trial.

A randomized clinical trial evaluated the therapeutic efficacy of group cognitive-behavioral therapy (GCBT) versus a wait-list control (WLC) condition to treat anxiety disorders in children. Results indicated that GCBT, with concurrent parent sessions, was highly efficacious in producing and maintaining treatment gains. Children in GCBT showed substantial improvement on all the main outcome measures, and these gains were maintained at 3-, 6-, and 12-month follow-ups. Children in the WLC condition did not show improvements from the pre- to postwait assessment point. These findings are discussed in terms of the need to continue to advance the development of practical, as well as conceptual, knowledge of efficacious treatment for anxiety disorders in children. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia

OBJECTIVE: To study the effect of fluoxetine (FL) and amitriptyline (AM), alone and in combination, in patients with fibromyalgia (FM). METHODS: Nineteen patients with FM completed a randomized, double-blind crossover study, which consisted of 4 6-week trials of FL (20 mg), AM (25 mg), a combination of FL and AM, or placebo. Patients were evaluated on the first and last day of each trial period. Outcome measures included a tender point score, the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI) scale, and visual analog scales (VAS) for global well-being (1 completed by the physician and 1 by the patient), pain, sleep trouble, fatigue, and feeling refreshed upon awakening. RESULTS: Both FL and AM were associated with significantly improved scores on the FIQ and on the VAS for pain, global well-being, and sleep disturbances. When combined, the 2 treatments worked better than either medication alone. Similar, but nonsignificant, improvement occurred in the BDI scale, the physician global VAS, and the VAS for fatigue and feeling refreshed upon awakening. Trends were less clear for the tender point score. CONCLUSION: Both FL and AM are effective treatments for FM, and they work better in combination than either medication alone.     

Treatment of acute cortical infarct with intravenous glycerol. A double-blind, placebo-controlled randomized trial

BACKGROUND AND PURPOSE: This clinical trial investigates the effectiveness of intravenous glycerol therapy in patients with acute cortical infarction in whom intracerebral hemorrhage was rigorously excluded. METHODS: Within 48 hours of symptoms from their first ischemic stroke, 113 hospital inpatients were randomized into the trial, provided that hemorrhage was excluded by computed tomography and informed consent was obtained. Patients were stratified into alert, semicoma, and coma groups using the Glasgow Coma Scale. Treatment was allocated according to a double-blind, randomized protocol; 56 patients received 500 mL of 10% glycerol in saline over 4 hours on 6 consecutive days, and 57 patients received corresponding placebo treatment with saline. Using a variety of objective scoring systems, patient follow-up was up to 6 months. RESULTS: Corresponding measures of outcome in the glycerol and placebo groups were similar. At 6 months, respective mortality rates were 17 of 56 and 16 of 57, and mean +/- SD improvements in scores were 9.98 +/- 14.40 vs 10.51 +/- 12.68 (long-term), 1.12 +/- 7.20 vs 1.57 +/- 6.30 (prognostic), -1.94 +/- 5.53 vs -2.06 +/- 5.34 (Glasgow Coma Scale), and 21.72 +/- 23.40 vs 11.94 +/- 18.10 (Barthel Index rating in survivors). Hemolysis (generally subclinical) was the only adverse effect. CONCLUSIONS: There was no clinically or statistically significant difference in outcome between the groups; a trend toward greater functional recovery among survivors was evident after treatment with glycerol.     

Play therapy with hospitalized children.

Provides a limited review of the literature pertaining to the use of play therapy in the hospital setting. Specific attention is given to situations involving the terminally ill child. V. Axline's (1969) original principles of play therapy are examined and applied to the play therapist's role in interactions with the hospitalized and/or terminally ill child. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized controlled trial of cognitive-behavioral treatment for posttraumatic stress disorder in severe mental illness.

A cognitive-behavioral therapy (CBT) program for posttraumatic stress disorder (PTSD) was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared with treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major mood disorder (85%) or schizophrenia or schizoaffective disorder (15%), of whom 25% also had borderline personality disorder. Eighty-one percent of clients assigned to CBT participated in the program. Intent-to-treat analyses showed that CBT clients improved significantly more than did clients in TAU at blinded posttreatment and 3- and 6-month follow-up assessments in PTSD symptoms, other symptoms, perceived health, negative trauma-related beliefs, knowledge about PTSD, and case manager working alliance. The effects of CBT on PTSD were strongest in clients with severe PTSD. Homework completion in CBT predicted greater reductions in symptoms. Changes in trauma-related beliefs in CBT mediated improvements in PTSD. The findings suggest that clients with severe mental illness and PTSD can benefit from CBT, despite severe symptoms, suicidal thinking, psychosis, and vulnerability to hospitalizations. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Psychological adjustment of children with mild and moderately severe asthma

In chronic hepatitis B virus (HBV) infection seroconversion from hepatitis B e antigen (HBeAg) to hepatitis B e antibody (HBeAb) may be followed either by remission of the disease with low-level viraemia, or by continuing inflammation with high-level viraemia. In both situations the virus may acquire a mutation in the precore sequence which prevents it from encoding HBeAg. We now show that the number of amino acid substitutions in the HBV core is low in viral sequences from patients with HBeAg positive chronic liver disease and HBeAg negative HBeAb positive patients in remission, but the frequency of substitutions is high in HBeAg, negative HBeAb positive patients with active liver disease. Furthermore we show that these substitutions cluster in the promiscuous CD4+ T-helper-cell epitope and in HBV core/e antibody binding determinants, but are not found in regions recognized by major histocompatability complex (MHC) restricted cytotoxic T lymphocytes. Sequential viral sequences from patients before and after HBeAg/HbeAb seroconversion shows that core mutations arise either at the same time or after the precore stop mutation which prevents the virus from encoding HBeAg. These results are consistent with the hypothesis that after clearance of HBeAg, mutations in regions of the virus recognized by CD4+ helper T cells and B cells allow persistence of the HBe negative virus in HBeAb positive patients with viraemia and active hepatitis.     

Serum immunoglobulins in children with asthma associated with severe respiratory tract infections

High school males (N = 109) and junior high school males (N = 112) administered the Physical Estimation and Attraction Scales (PEAS), the Tennessee Self-Concept Scale (TSCS), and a physical fitness battery. Previous research results were replicated in the h.s. group in that fitness and self-esteem were not significantly related but Estimation (of physical ability) correlated significantly with both fitness and self-esteem (p less than .01). Similar results were obtained in the jr. h.s. sample. Additionally, the validity of the Estimation (EST) scale was extended to include significant relationships with indices of emotional adjustment other than self-esteem. EST scores were shown to be influenced to significant but not inordinate degree by certain response bias tendencies. Negatively phrased EST items were denied significantly more often than positive EST items were affirmed and were more highly related to both response bias and emotional adjustment scores. Controlling for response bias influence by partial correlation failed to extinguish the significance of EST validating relationships. It was concluded that these relationships exist independently of response style or response set.     

The prevention of depressive symptoms in rural school children: A randomized controlled trial.

A controlled trial was conducted to evaluate a prevention program aimed at reducing depressive and anxious symptoms in rural school children. Seventh-grade children with elevated depression were selected. Nine primary schools (n=90) were randomly assigned to receive the program, and 9 control schools (n=99) received their usual health education classes. Children completed questionnaires on depression, anxiety, explanatory style, and social skills. Parents completed the Child Behavior Checklist (T. M. Achenbach, 1991). No intervention effects were found for depression. Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention. Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group

Intravenously administered ciprofloxacin was compared with imipenem for the treatment of severe pneumonia. In this prospective, randomized, double-blind, multicenter trial, which included an intent-to-treat analysis, a total of 405 patients with severe pneumonia were enrolled. The mean APACHE II score was 17.6, 79% of the patients required mechanical ventilation, and 78% had nosocomial pneumonia. A subgroup of 205 patients (98 ciprofloxacin-treated patients and 107 imipenem-treated patients) were evaluable for the major efficacy endpoints. Patients were randomized to receive intravenous treatment with either ciprofloxacin (400 mg every 8 h) or imipenem (1,000 mg every 8 h), and doses were adjusted for renal function. The primary and secondary efficacy endpoints were bacteriological and clinical responses at 3 to 7 days after completion of therapy. Ciprofloxacin-treated patients had a higher bacteriological eradication rate than did imipenem-treated patients (69 versus 59%; 95% confidence interval of -0.6%, 26.2%; P = 0.069) and also a significantly higher clinical response rate (69 versus 56%; 95% confidence interval of 3.5%, 28.5%; P = 0.021). The greatest difference between ciprofloxacin and imipenem was in eradication of members of the family Enterobacteriaceae (93 versus 65%; P = 0.009). Stepwise logistic regression analysis demonstrated the following factors to be associated with bacteriological eradication: absence of Pseudomonas aeruginosa (P < 0.01), higher weight (P < 0.01), a low APACHE II score (P = 0.03), and treatment with ciprofloxacin (P = 0.04). When P. aeruginosa was recovered from initial respiratory tract cultures, failure to achieve bacteriological eradication and development of resistance during therapy were common in both treatment groups (67 and 33% for ciprofloxacin and 59 and 53% for imipenem, respectively). Seizures were observed more frequently with imipenem than with ciprofloxacin (6 versus 1%; P = 0.028). These results demonstrate that in patients with severe pneumonia, monotherapy with ciprofloxacin is at least equivalent to monotherapy with imipenem in terms of bacteriological eradication and clinical response. For both treatment groups, the presence of P. aeruginosa had a negative impact on treatment success. Seizures were more common with imipenem than with ciprofloxacin. Monotherapy for severe pneumonia is a safe and effective initial strategy but may need to be modified if P. aeruginosa is suspected or recovered from patients.     

A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression

BACKGROUND: Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. METHODS: Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale--Revised, a measure of the severity depressive symptoms. RESULTS: Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated "much" or "very much" improved on the Clinical Global Impressions scale at study exit (chi 2 = 5.1, df = 1, P = .02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale--Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n = 48) and those aged 13 years and older (n = 48). However, complete symptom remission (Children's Depression Rating Scale--Revised < or = 28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. CONCLUSION: Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.     

Treatment effectiveness of parent management training in Norway: A randomized controlled trial of children with conduct problems.

This study was a randomized control trial (RCT) of Parent Management Training--The Oregon Model (PMTO) in Norway. A sample representing all health regions of Norway and consisting of 112 children with conduct problems and their families participated in the study. Families were randomly assigned to either PMTO or a regular services comparison group. PMTO was delivered via existing children's services, and families were recruited using the agencies' regular referral procedures, making this the first effectiveness study of PMTO and the first RCT of PMTO conducted outside of the United States. Using a multiagent-multimethod approach, results showed that PMTO was effective in reducing parent-reported child externalizing problems, improving teacher-reported social competence, and enhancing parental discipline. Age level and gender modified the effects of PMTO treatment on other outcomes. In a path model, participation in PMTO was associated with improved parental discipline, and effective discipline predicted greater child compliance, fewer child-initiated negative chains, and lower levels of child externalizing problems. Findings are presented along with a discussion of the implications for practice and research and the challenges accompanying effectiveness trials. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized trial of an intervention to prevent lawnmower injuries in children

Siberian hamsters (Phodopus sungorus sungorus) undergo photoperiod-induced physiological and behavioral adaptations. These adaptations, including changes in reproductive and metabolic status, are triggered by the pineal gland through the nocturnal secretion of its principal hormone, melatonin. The possible CNS sites of melatonin action determined through radiolabeled melatonin binding include the paraventricular and reuniens nuclei of the thalamus and the suprachiasmatic nucleus (SCN). However, we do not know the mechanisms and circuitry involved in the transmission of melatonin signals. Bilateral electrolytic lesions of the SCN (SCNx) block the responses to short day-like (long duration) melatonin signals delivered daily via the timed infusion paradigm, suggesting that the SCN receives and transmits short-day melatonin signals. The purpose of the present experiment was to answer the following question: are short-day melatonin signals transmitted to other brain structures from the SCN through its dorsomedial/dorsocaudal fiber projections? Pinealectomized adult male hamsters given horizontal knife cuts (kc) just dorsocaudal to the SCN (SCN-kc), sham-kc, or SCNx were given daily subcutaneous short day-like melatonin infusions via the timed infusion paradigm for 6 weeks. Only the hamsters given SCNx exhibited long day-like gonadal, epididymal fat pad, and body masses. Therefore, short day melatonin signals received by the SCN were not transmitted to other areas of the central nervous system through SCN efferents projecting dorsomedially or dorsocaudally.     

Parental criticism and treatment outcome in adolescents hospitalized for severe, chronic asthma

This pilot study investigated the relationship between parental criticism and medical treatment outcome across an inpatient hospitalization in 19 adolescents with severe, chronic asthma. Parental criticism toward their asthmatic adolescent was assessed using the Five Minute Speech Sample technique (FMSS) at the beginning of the adolescent's inpatient stay at a national asthma referral center. Those adolescents whose parents were rated as high in criticism on the FMSS were found to have greater improvement in their overall asthma severity, greater reduction in their steroid medication dose, and shorter lengths of stay in the hospital than those whose parents were rated as low in criticism. The adolescents whose parents were rated as high in criticism also showed lower compliance with their prescribed theophylline and oral steroid medication at admission than the low criticism group. These findings do not appear to be due to misdiagnosis secondary to the presence of vocal cord dysfunction or to the allergy status of the children. Clinical implications and possible causal mechanisms underlying these findings are discussed.     

Bibliotherapy for children with anxiety disorders using written materials for parents: A randomized controlled trial.

The current trial examined the value of modifying empirically validated treatment for childhood anxiety for application via written materials for parents of anxious children. Two hundred sixty-seven clinically anxious children ages 6-12 years and their parents were randomly allocated to standard group treatment, waitlist, or a bibliotherapy version of treatment for childhood anxiety. In general, parent bibliotherapy demonstrated benefit for children relative to waitlist but was not as efficacious as standard group treatment. Relative to waitlist, use of written materials for parents with no therapist contact resulted in around 15% more children being free of an anxiety disorder diagnosis after 12 and 24 weeks. These results have implications for the dissemination and efficient delivery of empirically validated treatment for childhood anxiety. (PsycINFO Database Record (c) 2010 APA, all rights reserved)