scholarly journals Organizational skills training for children with ADHD: study protocol for a randomized, controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aida Bikic ◽  
Søren Dalsgaard ◽  
Kristoffer Dalsgaard Olsen ◽  
Denis G. Sukhodolsky
Keyword(s):  
Treatment Response ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Skills Training ◽  
Control Group ◽  
Children With Adhd ◽  
Organizational Skills ◽  
Positive Effects ◽  
Link Type ◽  
Age Range

Abstract Background Problems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6–13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST. Objectives The primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children’s Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response. Methods This is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6–13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value. Perspectives This study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST. Trial registration ClinicalTrials.gov NCT03160378. Registered on May 19, 2017.

Organizational Skills Training for Children with ADHD

2017 ◽  
Vol 41 (S1) ◽  
pp. S123-S123
Author(s):  
A. Bikic ◽  
D. Sukhodolsky ◽  
S. Dalsgaard
Keyword(s):  
Academic Performance ◽  
Behavioral Problems ◽  
Controlled Trial ◽  
Strong Association ◽  
Skills Training ◽  
Primary Objective ◽  
Treatment As Usual ◽  
Children With Adhd ◽  
Organizational Skills ◽  
Students With Adhd

IntroductionIn addition to problems with inattention and hyperactivity, children with ADHD show poor organizational skills required for managing time and materials in academic projects. Poor organizational skills are associated with academic underachievement as well as psychosocial, occupational and economic difficulties. Behavioral approaches for ADHD are effective in reducing hyperactivity symptoms and behavioral problems, but the effects on academic functioning have been modest. An increasing emphasis on treatment of organizational skills has emerged in recent years, as difficulties with time management and organization of materials tend to persist and increase with age despite medication and behavioral treatments.ObjectivesThe primary objective is to investigate whether organizational skills training has a positive effect on organizational skills. The secondary and exploratory objectives are to investigate the effect on ADHD symptoms, adaptive functioning, academic performance and cognitive functions with a 24 weeks follow up.AimsOur goal is to provide cost-effective group-based treatment for children with ADHD and their parents. This will be the first randomized and controlled trial of organizational skills in Denmark.MethodsParticipants are included in two sites in Southern Denmark and will be randomized to Organizational skills training or treatment as usual. Organizational skills training will be provided in a group format for children and parents over 10 weeks.Perspectives Given the strong association between organizational skills and functional outcome, it is very important to address organizational skills in children and adolescents with ADHD as organizational skills deficits hinder the academic performance of even gifted students with ADHD and increase with age.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Safer cycling in older age (SiFAr): a protocol of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hanna Maria Siebentritt ◽  
Veronika Keppner ◽  
Sabine Britting ◽  
Robert Kob ◽  
Anja Rappl ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Older Age ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Cycling has positive effects on health and the proportion of older cyclists is rising. However, the risk for older adults to be injured or killed by a bicycle accident increases. The aim of the ongoing project “Safer Cycling in Older Age (SiFAr)” is to promote safer cycling in community-dwelling older adults with a structured, multi-component exercise training. Methods SiFAr is a randomized, controlled trial with a duration of 3 months for the intervention and a 6–9 months follow-up. We address community-dwelling persons aged 65 years and older living in the area Nürnberg-Fürth-Erlangen (Germany) who are either 1) beginners with the e-bike or 2) feeling self-reported unsteadiness when cycling or 3) uptaking cycling after a longer break. Long-term, experienced cyclists without subjectively reported limitations or worries when cycling are excluded. Participants are either randomized 1:1 to an intervention group (IG; receiving multi-component exercise program related to cycling, MEPC) or an active control group (aCG; receiving health and bicycle-related presentations, HRP). The purpose of this study is to investigate if the cycling competence of the IG will improve compared to the aCG. The cycling competence as primary outcome is tested not blinded in a standardized cycle course prior and after the intervention period, which consists of variant tasks requiring motor and cognitive skills related to traffic situations in daily life. Additional assessments such as physical functioning, quality of life, fear of falling, questionnaires regarding cycling behavior are obtained. To investigate the primary objective, regression analyses with difference of errors in the cycling course as independent variable and group as dichotomous dependent variable adjusted for covariates (sex, bicycle type) will be performed. The trial design is described in the present manuscript, using the extended CONSORT checklist for reporting pragmatic trials. Discussion Since there is a lack of cycling-related interventions for older people, SiFAr aims to evaluate a standardized intervention to enhance cycling safety. The results of the SiFAr trial could contribute to the implementation of an evaluated cycling course concept promoting mobility and independence of older adults. Trial registration This study was registered with clinicaltrials.gov: NCT04362514 on April 27, 2020

Goal Attainment and Treatment Compliance in a Cognitive-Behavioral Telephone Intervention for Family Caregivers of Persons with Dementia

GeroPsych ◽  
2011 ◽  
Vol 24 (3) ◽  
pp. 115-125 ◽  
Author(s):  
Gabriele Wilz ◽  
Denise Schinköthe ◽  
Renate Soellner
Keyword(s):  
Family Caregivers ◽  
Mentally Ill ◽  
Goal Attainment ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Treatment Success ◽  
Treatment Compliance ◽  
Control Group ◽  
Telephone Intervention ◽  
Effective Interventions

Introduction: The evaluation of effective interventions is still needed to prevent family caregivers of persons with dementia from becoming physically or mentally ill. However, in most existing intervention studies, primary outcomes are not well matched to the treatment goals. Method: A randomized controlled trial (N = 229) was conducted to compare a treatment group (CBT), a treated control group, and an untreated control group. In theses analyses we focused on the primary outcome measurement (GAS) as a perceived treatment success as well as treatment compliance and participants’ evaluation. Results: Results showed that 30.1% achieved complete goal attainment, 39.8% partial goal attainment, and 24.1% declared no change (overachievement 2.4%; deterioration 3.6%). Discussion: The intervention can be considered to have been successful.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Alireza Amanollahi ◽  
Sheikh Mohammed Shriful Islam ◽  
Jenna McVicar ◽  
...  
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receiving Bad News: A Randomized Controlled Trial

2014 ◽  
Vol 32 (20) ◽  
pp. 2166-2172 ◽  
Author(s):  
Maiko Fujimori ◽  
Yuki Shirai ◽  
Mariko Asai ◽  
Kaoru Kubota ◽  
Noriyuki Katsumata ◽  
...  
Keyword(s):  
Communication Skills ◽  
Patient Preferences ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Skills Training ◽  
Control Group ◽  
Communication Skills Training ◽  
Communication Performance

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Effects of Dog-Assisted Therapy on the Physical Function and Communication Skills of Adults with Autism: A Study Protocol for a Controlled Study

2021 ◽  
Vol 11 (22) ◽  
pp. 10650
Author(s):  
Isabel Gómez-Calcerrada ◽  
Ana Myriam Lavín-Pérez ◽  
Santos Villafaina ◽  
Juan Carlos Rueda-Rubio ◽  
Beatriz Rivera-Martín ◽  
...  
Keyword(s):  
Communication Skills ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Controlled Study ◽  
Control Group ◽  
Adults With Autism ◽  
Treatment As Usual ◽  
Positive Effects ◽  
Adults With Asd ◽  
Gait Posture

Background and Objectives: Despite the scientific evidence of the positive effects of animal-assisted therapy (AAT) in adults with autism spectrum disorder (ASD), it is not still considered an evidence-based practice for this population. The proposed study will aim to evaluate the effects of a dog-assisted therapy program on gait, posture, and communication skills. Materials and Methods: A total of 24 adults with ASD will participate in this non-randomized controlled trial. The experimental group will involve 12 participants who will receive AAT for 10 weeks, at two sessions per week. The focus of these sessions will be conducting different activities and physical exercises, facilitated by dogs. The control group will receive treatment as usual. The outcome measures will be the ability to walk and climbing stairs, balance, risk of falls and communication skills. Conclusions: The role of dogs as facilitators of the movement may lead to relevant benefits in the gait, posture and communication skills of adults with ASD, improving their ability to perform activities of daily living.

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