Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/ hyperactivity disorder

Objective: The primary objective of this study was to assess the impact of atomoxetine in combination with psychoeducation, compared with placebo and psychoeducation, on health-related quality of life (HRQL) in Swedish stimulant-naïve pediatric patients with attention deficit/ hyperactivity disorder (ADHD). HRQL results will be presented elsewhere. Here, psychoeducation as well as efficacy and safety of the treatment are described. Patients and methods: A total of 99 pediatric ADHD patients were randomized to a 10-week double-blind treatment with atomoxetine (49 patients) or placebo (50 patients). Parents of all patients received four sessions of psychoeducation. Atomoxetine was dosed up to approximately 1.2 mg/kg day (≤70 kg) or 80 mg/day (>70 kg). Improvement of ADHD symptoms was evaluated using the ADHD rating scale (ADHD-RS) and clinical global impression (CGI) rating scales. Safety was assessed based on adverse events (AEs). Results: The study population was predominantly male (80.8%) and diagnosed with the combined ADHD subtype (77.8%). The least square mean (lsmean) change from baseline to endpoint in total ADHD-RS score was −19.0 for atomoxetine patients and −6.3 for placebo patients, resulting in an effect size (ES) of 1.3 at endpoint. Treatment response (reduction in ADHD-RS score of ≥25 or ≥40%) was achieved in 71.4 or 63.3% of atomoxetine patients and 28.6 or 14.3% of placebo patients. The lsmean change from baseline to endpoint in CGI-Severity was −1.8 in the atomoxetine group compared with −0.3 in the placebo group. The difference between treatments in CGI-Improvement at endpoint was −1.4 in favor of atomoxetine. No serious AEs occurred. The safety profile of atomoxetine was in line with the current label. Conclusions: Atomoxetine combined with psychoeducation was superior to placebo and psychoeducation in ADHD core symptoms improvement. The large ES might be a result of including stimulant-naïve patients only, but also may indicate a positive interaction between atomoxetine treatment and psychoeducation, possibly by increased compliance

Atomoxetine improves patient and family coping in attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in Swedish children and adolescents

This 10-week study assessed the efficacy of atomoxetine in combination with psychoeducation compared to placebo and psychoeducation in the improvement of Quality of Life in Swedish stimulant-naive children and adolescents with attention deficit/hyperactivity disorder. A total of 99 patients were treated with atomoxetine (49 patients) or placebo (50 patients) for 10 weeks and assessed regarding broader areas of functioning using the Quality of Life measures Child Health and Illness Profile-Child Edition (CHIP-CE), Family Strain Index [FSI; equivalent to the Family Burden of Illness Module used in the study], Appraisal of Stress in Child-Rearing (ASCR), Five to fifteen (FTF), “I think I am” (“Jag tycker jag är”), and Children’s Depression Rating Scale-Revised (CDRS-R) before and after the active treatment phase. Simultaneously, the patients’ parents participated in a 4-session psychoeducation program. A statistically significant difference in favor of atomoxetine was seen in the improvement from baseline to study endpoint for the CHIP-CE domains “Achievement” and “Risk avoidance”, for the FSI total score, for the ASCR section (I) domain “Child as a burden”, for all FTF domains except for “Language and Speech”, and for the CDRS-R total score. No difference between treatment groups was observed in the patient-assessed evaluation of self-esteem using the “I think I am” scale. Atomoxetine combined with psychoeducation had a positive effect on various everyday coping abilities of the patients as well as their families during 10 weeks of treatment, whereas the patients’ self-image and the parents’ image of the climate in the family were not significantly improved

Health-related quality of life in adolescents with chronic physical illness in northern Russia : a cross-sectional study.

BACKGROUND: Health related quality of life (HRQoL) is an important subjectively evaluated outcome of adolescents physical, mental, and social functioning. It gives us the possibility to assess the disease impact on life of adolescents, and to sort out target groups of adolescents for future psychological interventions. The objective of this cross-sectional survey was to study HRQoL in 173 adolescents with chronic physical illness (CPI - diabetes, asthma, and epilepsy), and to find HRQoL predictors in each disease group. METHODS: Disease-specific questionnaires were completed by each adolescent recruited from the local outpatient clinic; mothers answered the questions on socioeconomic status (SES); and the patients' clinicians evaluated the severity of the disease. RESULTS: A high proportion of adolescents in each disease specific sample reported moderate to high levels of HRQoL. Gender was the most prominent predictor of HRQoL in all three studied groups, while disease severity predicted HRQoL in the diabetic group and to some extent in the asthma group. CONCLUSIONS: Our results provide evidence that adolescents with diabetes, asthma, and epilepsy in northern Russia maintain relatively moderate to high levels of HRQoL. The domains affecting HRQoL were related to both disease-specific (severity) and non-disease factors (gender and SES). Our study suggests that future psychosocial interventions should focus on aspects of CPI impacting adolescents in gendered ways, furthermore taking into account disease specific factors

Child behaviour after anaesthesia: associated risk factors

AIM: To identify hospital care factors which are associated with problematic behaviours in children after hospitalization. METHOD: A cohort of 340 children ages 2-13 was studied in connection with elective procedures which included anaesthesia. Data collected: sociodemographic, type of procedure, anaesthesia induction technique and premedication. Staff and parents assessed child anxiety at induction of anaesthesia, pain, anxiety and nausea in recovery room and hospital ward. Parents assessed their child's pain and nausea and the behaviour measured with the Post Hospital Behavioural Questionnaire two weeks after hospitalization. RESULTS: One-third (34.4 %) of the children developed at least one problematic behaviour, measured by the PHBQ subscales. Multiple logistic regression identified the following risk factors: age <5, pain at home but not at hospital, nausea, child anxiety at anaesthesia induction, postoperative nausea, postoperative distress, previous hospitalizations, living in a one adult family and having some previous problematic behaviours. Moderate-to-severe pain at home, but not at hospital, was associated with the greatest risk (OR 6.39 CI: 3.53-11.6). Previous anaesthesia, midazolam use in premedication and living in rural areas seemed to be protective factors. CONCLUSION: Pain at home but not in hospital is a strong risk factor for the onset or worsening of problematic behaviour after childhood hospitalization, which included anaesthesia. Proactive interventions are suggested to prevent this by improving pain treatment at home.Karling, M Stenlund, H Hagglof, B Research Support, Non-U.S. Gov't Norway Acta paediatrica (Oslo, Norway : 1992) Acta Paediatr. 2007 May;96(5):740-7

Internalized symptoms in adolescence as predictors of mental health in adulthood in the Northern Swedish cohort

Although mental health symptoms in children and adolescents are shown to predict young adult mental health outcomes, long-term prospective studies of childhood cohorts are few. The aim of the present study was to analyze the prospective importance of internalized mental health symptoms in adolescence for internalized symptoms in adulthood. Methods: A communitybased prospective longitudinal cohort provided information by questionnaire about psychological status at age 16 and 43 (n = 1010, representing 94.3% of those still alive). Socio-demographic variables which were indicative of possible childhood adversity (parental class, absence, illness, unemployment, relationship, crowding, number of moves) were treated as confounders and controlled for in ordinal regression. Results: For both women and men, internalizing mental health symptoms reported at 16 significantly predicted the same outcome at 43 years, after controlling for previous adverse environmental conditions (OR = 1.2 for women, 1.3 for men). Conclusion: In this representative cohort studied over 27 years with excellent retention rates, the occurrence of self-reported worry, panic and sadness in mid-adolescence significantly increased the likelihood of similar states in middle adulthood

Increase of internalized mental health symptoms among adolescents during the last three decades

Background: Previous studies suggest an overall increase of adolescent mental health symptoms globally since the 1980s until today, especially an increase of internalizing symptoms in girls. Due to methodological limitations of these studies, further studies are warranted to obtain a more solid knowledgebase. Methods: This study was cross-sectional and compared two separate but geographically identical groups of adolescents in a middle-sized industrial municipality in Northern Sweden at two time-points [(i) 1981, n = 1083, (505 girls, 577 boys), response rate 99.7%; (ii) 2014, n = 682, (338 girls, 344 boys), response rate 98.3%]. All students in their last year of compulsory school were included. The same self-report questionnaire, consisting of four sub-scales (functional somatic-, anxiety-, depressive symptoms and conduct problems), was used at both occasions. Data were analyzed with descriptive statistics, two-way ANOVA and general linear model. Results: Symptoms of anxiety and depression and functional somatic symptoms, increased among both boys and girls from 1981 until 2014 (P < 0.001 for all subscales), and the increase of these symptoms was higher in girls. Conduct problems were significantly higher in boys in 1981 and decreased over time so that in 2014 there was no longer a significant difference between boys and girls regarding conduct problems (P = 0.286). Conclusion: In this population-based study spanning over 30 years, both girls and boys showed increasing internalizing problems, while conduct problems decreased. To halt this trend, we need a deeper understanding of the impact of the major societal changes that have occurred during the last three decades

Child war trauma: a comparison of clinician, parent and child assessments.

This paper focuses on the difficulty of capturing child war trauma: the appropriateness of a standardized trauma questionnaire and the value of recruiting multiple reports. Three independent assessments of the war exposure of 75 Bosnian refugee children and teenage youths (aged 1-20), resettled in Sweden, are compared: clinician assessment based upon a semi-structured interview with the family, child self-report on the Harvard Trauma Questionnaire (HTQ) and parent report on the same questionnaire. Parent and clinician reports show marked group similarities but differ often with regard to the individual child. Clinician score reveals a social class gradient not visible on the HTQ. Parent and teenager assessments correlate strongly on total exposure but diverge markedly on specific events. Discrepancy derives as frequently from events affirmed by teenager alone as by parent alone. Primary school children, on the other hand, systematically offer a less-detailed account of their own war exposure. In summary, original HTQ functions "quite well" as a standardized questionnaire, but a Bosnian-specific version would expectedly afford greater validity and capture social class differences in child exposure. For teenagers, the value of multiple informants appears evident; for primary school children, a more adequately age-adjusted procedure remains the first priority

Mental health of Bosnian refugee children: a comparison of clinician appraisal with parent, child and teacher reports.

This study compares clinician appraisal of Bosnian refugee children with independent parent, child and teacher reports. From whom and by what means can children "at risk" be reasonably identified? Forty-eight Bosnian refugee children (aged 7-20), resettled in Sweden 1994-95, were assessed clinically by means of a semi-structured interview. Thereafter, standardized mental health questionnaires were administered to parents (Achenbach's Child Behavior Checklist), children (Achenbach's Youth Self-Report and Macksoud's Posttraumatic Stress Reaction Checklist) and teachers (clinician designed School Competence Scale and Achenbach's Teacher's Report Form). On clinician interview, nearly half of the children (48%) were identified with one or more mental health problem "demanding further attention". Depressiveness was the single most prevalent symptom (31%); followed by post-traumatic stress (23%), and anxiety-regressiveness (15%). At the same time, 75% of the children were rated by teachers as "quite competent" in school. Parent, child and clinician appraisals of primary school children showed broad similarities. Teachers reported a similar prevalence of child distress, but identified different symptoms and different children demanding attention. Evaluation of teenage youths showed greater disparity: teenagers labeled their own symptoms more often as post-traumatic stress reactions and teachers identified few youths in need of attention. Inter-relatedness among parent, child and clinician appraisals supports the robustness of our semi-structured interview. At the same time, apartness of teacher report underscores the need to incorporate an outside-world vantage point in the process of risk assessment. Also, a more concrete presentation of post-traumatic stress reactions and a higher "further attention" threshold for inward emotional problems seem called for

Differences and Similarities of Mental Health Problems Reported by Adolescents : From Greece, Japan, Russia, and Sweden

The aims of the present study were to: 1) compare scores and scales of the Youth Self-Report (YSR) reported by healthy adolescents 15 - 17 years of age from Greece, Japan, Russia, and Sweden, 2) analyze gender and age effects of the YSR syndrome scores between and within countries, and 3) compare scores of competence scales and their associations to mental health problems. A comparison of problems (n = 812) yields a small effect size of 4.8% for cross-country in YSR total problems scores. There was a deviation above the overall mean for Greece and Russia, while Sweden and Japan had deviations below the mean. The effect sizes of country for narrowband and broadband scales were small or medium. Analysis within and between countries pointed out some problems that might be more/less common in some countries than others. In their total competence score, Greek adolescents scored higher than Swedish or Japanese. There were some negative associations between syndrome and competence scales across countries. Gender differences were shown across the countries with the exception of Japan. Age differences were less consistent due to the small range of age groups. Even though YSR is used in all four countries, translations and sampling procedure may influence (be one of) the variations

Effects of Parent Training Programmes on Parents' Sense of Competence in a General Population Sample

INTRODUCTION: This longitudinal case-controlled study examined the effects of universal parent-focused interventions on parents’ perceived competence in terms of parental efficacy and satisfaction. METHOD: The study sample consisted of parents from northern Sweden in the general population who participated in parent training programmes from 2010 to 2013, and a matched-comparison group. All parents had children aged 0–17. Sense of competence was measured by the Parenting Sense of Competence Scale at pre- and post-intervention and six months after the intervention. RESULTS: The intervention group showed a statistically significant improvement in parental competence compared to the comparison group over time. The intervention itself had a significant effect on parental satisfaction, but the efficacy effect was not sustained when taking into account potential confounders. CONCLUSIONS: Earlier studies indicate that parent training programmes enhance perceived parental competence amongst referred parents. The present study shows that parent training programmes applied in the general population may also enhance perceived parental satisfaction, suggesting that parent training programmes can be an important preventive strategy to enhance parental feelings of satisfaction in the wider population. The results suggest that parents who participate in parent training programmes might have a need to increase parental competence, based on lower scores than the comparison group, both before and after the intervention