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Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

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Summary: We have developed a short, patient-reported outcome questionnaire-the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 ( n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose: To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults. Methods: In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points. Results: The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P ≤ 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D ≥ 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D ≥ 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration ( r = −0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine ( P ≥ 0.22). Conclusions: Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future. [ABSTRACT FROM AUTHOR]

Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took part in the pilot RCT. A range of primary and secondary outcome measures were collected on four occasions (baseline, 10, 18 and 24 weeks) to capture both independent ratings and parent-reported changes in RRB. This pilot established that parents were willing to be recruited and randomised, and the format and content of the intervention was feasible. Fidelity of delivery was high, and attendance was 90 %. A fully powered trial is now planned. [ABSTRACT FROM AUTHOR]

Acceptance-based psychological interventions can potentially minimize the burden of chronic pain. This randomized controlled trial evaluated an internet-delivered, guided self-help intervention based on Acceptance and Commitment Therapy (ACT). A total of 238 chronic pain sufferers from the general population were randomly allocated to either ACT (n = 82), an internet-based control condition Expressive Writing (n = 79) or a waiting list condition (n = 77). Participants completed measures at baseline, posttreatment (3 months) and at a 3-month follow-up. At follow-up, ACT participants had improved in pain interference in daily life (primary outcome) compared to participants in Expressive Writing (Cohen's d = .47), but not compared to waiting list participants ( p value = .11). Those who adhered to the ACT-intervention (48 %) did improve significantly compared to waiting list participants (d = .49). ACT-participants also showed superior improvement on depression, pain intensity, psychological inflexibility and pain catastrophizing (d: .28-.60). Significant clinical improvement was present. Especially, 28 % of ACT-participants showed general clinically relevant improvement in pain interference, as well as in pain intensity and depression (vs. Expressive Writing and waiting list 5 %). Given these findings, internet-based ACT programs may be a promising treatment modality for chronic pain. [ABSTRACT FROM AUTHOR]

The purpose of this pilot study was to evaluate the efficacy of the interview skills curriculum (ISC), a manualized 12-week group-delivered intervention for young adults with autism spectrum disorder (ASD). This intervention aims to increase social-pragmatic skills essential to a successful job interview. Twenty-eight adults (18-36 years) were randomly assigned to one of two groups: ISC or waitlist control. Results revealed that the experimental group showed larger gains in social-pragmatic skills observed during a mock job interview than the control group. Treatment effects on distal outcomes, including social adaptive behaviors and depressive symptoms were not significant, although the respective effect sizes were medium/large. Results indicate that a brief, low-intensity treatment can improve the job-interview performance of young adults with ASD. [ABSTRACT FROM AUTHOR]

The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in J Autism Dev Disord 43:540-555, ). The current analyses focus on children's attachment related outcomes. Results revealed that children who were randomly assigned to FPI showed bigger increases in attachment-related behaviors, compared to children assigned to the control condition. Significant treatment effects of FPI were found for both an observational measure of attachment-related behaviors elicited during a brief separation-reunion episode and a questionnaire measure evaluating parental perceptions of child attachment. The theoretical and clinical implications of these findings are discussed. [ABSTRACT FROM AUTHOR]

The prevalence of sleep disturbance among children with developmental disabilities is known to be considerably higher than the typical population. The current study examined the effectiveness of the Sleepwise intervention program (O'Connell and Vannan in Aust Occup Ther J 55:212-214, ): a parent-assisted group-based treatment for sleep disturbance which was recently adapted for older children and adolescents with DD. Twenty-six families with children aged 8-17 years participated. The study compared a treatment and a wait-list control group at baseline, post-treatment and 2 months post-treatment on measures of child and parent functioning. Results demonstrated that the Sleepwise approach was effective in reducing sleep disturbance and parent stress. Limitations and future research directions are discussed. [ABSTRACT FROM AUTHOR]

Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV. [ABSTRACT FROM AUTHOR]

Accurate estimation of the effectiveness of a microbicide for HIV prevention requires valid measurement of adherence to product use. A microbicide gel applicator container (Wisebag), fitted with cell phone technology to transmit opening events and text message reminders, was developed to monitor each opening event of the container as a proxy for gel use and adherence. Ten women were enrolled in a pilot study and followed for up to 4 months. Wisebag opening (WBO) dates and times were recorded and correlated with self-reported sex acts and gel applicator returns. During the 33 monthly follow-up visits, 47.8 % (77/161) of the recorded number of WBO events were concordant with the number of empty (used) applicators returned. The discrepancies were likely due to removal of more than one applicator during a single opening event. When the date and time of the WBO event data was assessed in relation to three different self-report adherence measures, agreement was fairly modest. The Wisebag was found to be acceptable as a storage container and the cell phone reminders generated were useful in supporting the dosing strategy. We recommend that the Wisebag be considered for larger scale and lengthier testing in microbicide trials. [ABSTRACT FROM AUTHOR]

This study investigated the impact of a parent-coaching intervention based on the Early Start Denver Model (P-ESDM) on parenting-related stress and sense of competence. This was part of a multisite, randomized trial comparing P-ESDM (n = 49) with community intervention (n = 49) for children aged 12 and 24 months. The P-ESDM group reported no increase in parenting stress, whereas the Community group experienced an increase over the same 3-month period. Parental sense of competence did not differ. Number of negative life events was a significant predictor of parenting stress and sense of competence across both groups. This suggests that a parent-coaching intervention may help maintain parental adjustment directly after a child is diagnosed with ASD. [ABSTRACT FROM AUTHOR]

Elders living alone may experience worse health outcomes than do those living with spouse and/or children. Using baseline data from a randomized trial to promote high blood pressure (HBP) control in Korean elders (N = 440), we examined the relationship between living arrangements and HBP control. We also interviewed a sub-sample to better understand the patterns of social interactions associated with different types of living arrangements. One in five reported living alone; this group tended to be older and female, and resided in senior group housing. Those living alone were twice as likely as those living with a spouse to have controlled BP (OR = 2.08; 95 % CI 1.09-3.97), even after controlling for study covariates. Those in senior group housing had frequent social interactions that involved conversations around health, encouragement concerning medication taking, and health information sharing. In conclusion, Korean elders living independently are neither socially-isolated nor at increased risk for poor BP control. [ABSTRACT FROM AUTHOR]

Summary: We have investigated whether low-dose vitamin K2 supplements (menaquinone-7, MK-7) could beneficially affect bone health. Next to an improved vitamin K status, MK-7 supplementation significantly decreased the age-related decline in bone mineral density and bone strength. Low-dose MK-7 supplements may therefore help postmenopausal women prevent bone loss. Introduction: Despite contradictory data on vitamin K supplementation and bone health, the European Food Safety Authorities (EFSA) accepted the health claim on vitamin K's role in maintenance of normal bone. In line with EFSA's opinion, we showed that 3-year high-dose vitamin K1 (phylloquinone) and K2 (short-chain menaquinone-4) supplementation improved bone health after menopause. Because of the longer half-life and greater potency of the long-chain MK-7, we have extended these investigations by measuring the effect of low-dose MK-7 supplementation on bone health. Methods: Healthy postmenopausal women ( n = 244) received for 3 years placebo or MK-7 (180 μg MK-7/day) capsules. Bone mineral density of lumbar spine, total hip, and femoral neck was measured by DXA; bone strength indices of the femoral neck were calculated. Vertebral fracture assessment was performed by DXA and used as measure for vertebral fractures. Circulating uncarboxylated osteocalcin (ucOC) and carboxylated OC (cOC) were measured; the ucOC/cOC ratio served as marker of vitamin K status. Measurements occurred at baseline and after 1, 2, and 3 years of treatment. Results: MK-7 intake significantly improved vitamin K status and decreased the age-related decline in BMC and BMD at the lumbar spine and femoral neck, but not at the total hip. Bone strength was also favorably affected by MK-7. MK-7 significantly decreased the loss in vertebral height of the lower thoracic region at the mid-site of the vertebrae. Conclusions: MK-7 supplements may help postmenopausal women to prevent bone loss. Whether these results can be extrapolated to other populations, e.g., children and men, needs further investigation. [ABSTRACT FROM AUTHOR]

Healthy Choices, a four-session motivational interviewing-based intervention, reduces risk behaviors among US youth living with HIV (YLWH). We randomized 110 Thai YLWH (16-25 years) to receive either Healthy Choices or time-matched health education (Control) over 12 weeks. Risk behaviors were assessed at baseline, 1, and 6 months post-session. The pilot study was not powered for between-group differences; there were no statistical differences in sexual risks, alcohol use, and antiretroviral adherence between the two groups at any visit. In within-group analyses, Healthy Choices group demonstrated decreases in the proportion of HIV-negative partners (20 vs 8.2 %, P = 0.03) and HIV sexual risk scores (4.3 vs 3.3, P = 0.04), and increased trends in the proportion of protected sex (57 vs 76.3 %, P = 0.07) from baseline to 1 month post-session. These changes were not sustained 6 months later. No changes were observed in Control group. Healthy Choices has potential to improve sexual risks among Thai YLWH. [ABSTRACT FROM AUTHOR]

We assessed the acceptability of three of over-the-counter products representative of potential rectal microbicide (RM) delivery systems. From 2009 to 2010, 117 HIV-uninfected males (79 %) and females (21 %) who engage in receptive anal intercourse participated in a 6-week randomized crossover acceptability trial. Participants received each of three products (enema, lubricant-filled applicator, suppository) every 2 weeks in a randomized sequence. CASI and T-ACASI scales assessed product acceptability via Likert responses. Factor analysis was used to identify underlying factors measured by each scale. Random effects models were fit to examine age and gender effects on product acceptability. Three underlying factors were identified: Satisfaction with Product Use, Sexual Pleasure, and Ease of Product Use. For acceptability, the applicator ranked highest; however, differences between product acceptability scores were greatest among females and younger participants. These findings indicate that RM delivery systems impact their acceptability and should be considered early in RM development to enhance potential use. [ABSTRACT FROM AUTHOR]

Researchers and practitioners conduct multi-informant assessments of child and family behavior under the assumption that informants have unique perspectives on these behaviors. These unique perspectives stem, in part, from differences among informants in the settings in which they observe behaviors (e.g., home, school, peer interactions). These differences are assumed to contribute to the discrepancies commonly observed in the outcomes of multi-informant assessments. Although assessments often prompt informants to think about setting-specific behaviors when providing reports about child and family behavior, the notion that differences in setting-based behavioral observations contribute to discrepant reports has yet to be experimentally tested. We trained informants to use setting information as the basis for providing behavioral reports, with a focus on parental knowledge of children's whereabouts and activities. Using a within-subjects controlled design, we randomly assigned 16 mothers and adolescents to the order in which they received a program that trains informants to use setting information when providing parental knowledge reports ( Setting- Sensitive Assessment), and a control program involving no training on how to provide reports. Relative to the control program, the Setting-Sensitive Assessment training increased the differences between mother and adolescent reports of parental knowledge, suggesting that mothers and adolescents observe parental knowledge behaviors in different settings. This study provides the first experimental evidence to support the assumption that discrepancies arise because informants incorporate unique setting information into their reports. [ABSTRACT FROM AUTHOR]

Parental depression places offspring at elevated risk for multiple, co-occurring problems. The purpose of this study was to develop and preliminarily evaluate Project Hope, a family intervention for the prevention of both depression and substance use among adolescent-aged children ( M = 13.9 years) of depressed parents. The program was created by blending two empirically supported interventions: one for depression and another for substance use. Thirty families were randomly assigned to either Project Hope ( n = 16) or a wait-list control condition ( n = 14). Pretests, posttests ( n = 29), and 5-month follow-ups ( n = 28) were conducted separately with parents and youth via phone interviews. Questions asked about the family depression experience, family interactions, family management, coping, adolescent substance use beliefs and refusal skills, adolescent depression, and adolescent substance use. Project Hope was fully developed, manualized, and implemented with a small sample of targeted families. Engagement in the program was relatively high. Preliminary outcome analyses were conducted using 2 (Group) ×3 (Time) analyses of covariance. Results provided some evidence for significant improvements among intervention compared to control participants in indicators of the family depression experience, family management, and coping, and a statistically significant decrease from pretest to posttest in alcohol quantity for intervention compared to control youth. Next steps for this program of research are discussed. [ABSTRACT FROM AUTHOR]

Assertive Community Treatment (ACT) is an outreach-based case management model that assists people with severe mental illness through an intensive and integrated approach. In this program, a multidisciplinary team provides medical and psychosocial services. The purpose of this study was to examine the effectiveness of the following two ACT intervention strategies: 'replacement' (supporting the clients) versus 'backup' (supporting family members who provide care to clients). Admission days, psychiatric symptoms, quality of life, self-efficacy, and service satisfaction ware evaluated as outcome variables. To identify effective methods of supporting family members, clients living with family were divided into two groups based on the amount and types of services received-the backup group and the replacement group. ANCOVA was used to compare the outcomes between the two groups. The replacement group displayed significantly better psychiatric symptoms, social functioning, self-efficacy, and service satisfaction scores. No differences in admission days or quality of life were found. Clients provided more support directly to clients themselves than to family members was found to have better client outcomes in improving psychiatric symptoms, social functioning, and self-efficacy, resulting in higher levels of service satisfaction. This indicates that society should reduce the responsibility of the family and share responsibility for the care of people with mental illness to effectively improve outcomes for people with mental illnesses. [ABSTRACT FROM AUTHOR]

The study was conducted to examine the relative effectiveness of cognitive behavior therapy with a cultural tailoring intervention compared to brief medication management. The study used a two-arm randomized controlled trial in which participant assignment was stratified by gender. The intervention condition received eight weekly 40-min individualized counseling sessions of culturally tailored cognitive behavior therapy, while the control condition received eight weekly 10-min individualized counseling sessions of medication management. Both conditions received nicotine patches for 8 weeks. Data were collected at baseline and at four follow-up points (one and 4 weeks, and three and 6 months post-quit). Treatment outcomes were presented as an intention-to-treat analysis. Thirty Korean immigrants participated in the study. At 6-month follow-up, 57.1% of participants in the intervention and 18.8% of participants in the control had 7-day point prevalence abstinence (odds ratio = 5.8, 95% confidence interval = 1.12-26.04, P = 0.04). Participants' self-reported abstinence was biochemically verified with exhaled carbon monoxide and salivary cotinine levels. A combination of the culturally tailored cognitive behavior therapy and nicotine replacement therapy had a better treatment outcome compared to brief medication management. The promising result suggests a need to further test the intervention in larger samples and longer follow-up assessments before it can be adapted in clinical settings. [ABSTRACT FROM AUTHOR]

Peer outreach models have been successful in addressing HIV risk behaviors of drug users. Patients in methadone maintenance treatment programs who were migrants from Puerto Rico and/or familiar with drug use there were trained to conduct HIV-related peer outreach. A group randomized design was implemented; patients in the Experimental (E) condition (n = 80) received training and conducted 12 weeks of outreach. Half of the patients completed the training and outreach. At follow-up, patients in the E condition who conducted outreach felt they were more helpful to their community, showed a trend for engaging in more vocational activities, and were more likely to talk with others about HIV, compared to those who did not conduct outreach and those in the Control condition (n = 78). Drug treatment patients who are migrants can be trained as peer outreach workers and short-term benefits were found. Longer term maintenance of benefits should be assessed. [ABSTRACT FROM AUTHOR]

Aim: Previous studies have demonstrated a positive effect of school-based life skills programmes on the prevention of substance abuse and other health-risk behaviours in children and adolescents. However, the comparison and interpretation of study results is difficult due to methodological problems. In particular, the effectiveness of such programmes within high-risk groups remains uncertain. In this study, we investigated the effects of two school-based life skills programmes on substance abuse and subjective health in a sample with a high proportion of socially disadvantaged pupils. Subjects and methods: We conducted a randomised controlled intervention study with repeated measurements over time. The sample included pupils of secondary schools in northern Germany with an overrepresentation of pupils with low socioeconomic status. We evaluated effects of the programmes on substance abuse and psychosocial outcomes. In addition, we conducted a process evaluation. Results: The sample included 102 classes with a total of 1,561 pupils. Twenty-five per cent of the pupils were of a low socioeconomic status. We found significant positive effects regarding the reduction of smoking and some improvements in the pupils' life skills in the intervention group compared to the control group. Socioeconomic status had no moderating effect on the results. Conclusion: School-based life skills programmes have a positive effect on smoking prevention regardless of socioeconomic status. Socially disadvantaged children benefit from such programmes to a similar extent as other pupils. Pupils and teachers appreciate the programmes. A supportive school environment appears to be an important factor in the successful implementation of school-based life skills programmes. [ABSTRACT FROM AUTHOR]

Introduction Beside (cost-)effectiveness, the feasibility of an intervention is important for successful implementation in daily practice. This study concerns the process evaluation of a newly developed participatory return-to-work (RTW) program for workers without an employment contract, sick-listed due to musculoskeletal disorders. The program consisted of a stepwise process, guided by an independent RTW coordinator, aimed at making a consensus-based RTW plan with the possibility of a temporary (therapeutic) workplace. The aims of this study were to describe the reach and extent of implementation of the new program, the satisfaction and experiences of all stakeholders, and the perceived barriers and facilitators for implementation of the program in daily practice. Methods Temporary agency workers and unemployed workers, sick-listed for 2-8 weeks due to musculoskeletal disorders were eligible for this study. Data were collected from the workers; their insurance physicians and labour experts at the Dutch Social Security Agency; RTW coordinators; and case managers from participating vocational rehabilitation agencies. Data collection took place using professionals' reports, standardized matrices, questionnaires at baseline and at 3-month follow-up, and group interviews with the professionals. Results Of the 79 workers who were allocated to the participatory RTW program group, 72 workers actually started with the intervention. Overall, implementation of the program was performed according to protocol. However, offering of suitable temporary workplaces was delayed with 44.5 days. Results showed satisfaction with the RTW coordinator among the workers and three quarters of the labour experts experienced a minor or major contribution of the presence of the RTW coordinator. Several barriers for implementation were identified, such as the administrative time-investment, unclear information about the program, no timely offering of temporary (therapeutic) workplaces, and the need for additional support in case of complex health problems. Conclusions This study indicates overall feasibility for implementation of the participatory RTW program in daily practice. However, to overcome important barriers, more attention should be paid to improve timely offering of suitable temporary workplaces, to describe more clearly the program goals and the professional's roles, and to offer additional support for workers suffering from complex multi-causal health problems. Trial registration NTR1047. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of cognitive-behavioral treatment (CBT) in inner city schools, when delivered by novice CBT clinicians, and compared to usual care (UC), is unknown. Objective: This pilot study addressed this issue by comparing a modular CBT for anxiety disorders to UC in a sample of 32 volunteer youth (mean age 10.28 years, 63% female, 84% African American) seen in school-based mental health programs. Methods: Youth were randomly assigned to CBT ( n = 17) or UC ( n = 15); independent evaluators conducted diagnostic interviews with children and parents at pre- and post-intervention, and at a one-month follow-up. Results: Based on intent-to-treat analyses, no differences were found in response rates between groups with 50 and 42% of the children in CBT, compared to 46 and 57% in UC no longer meeting criteria for an anxiety disorder at post-treatment and follow-up respectively. Similar improvements in global functioning were also found in both treatment groups. Baseline predictors of a positive treatment response included lower anxiety, fewer maladaptive thoughts, less exposure to urban hassles, and lower levels of parenting stress. Therapist use of more CBT session structure elements and greater competence in implementing these elements was also related to a positive treatment response. Conclusions: Findings from this small pilot failed to show that CBT was superior to UC when delivered by school-based clinicians. Large scale comparative effectiveness trials are needed to determine whether CBT leads to superior clinical outcomes prior to dissemination. [ABSTRACT FROM AUTHOR]