KONTAKT© in Australian Adolescents on the Autism Spectrum: Protocol of a Randomized Control Trial

Abstract Background: Individuals diagnosed with Autism Spectrum Disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (i) replication of effects in additional clinical and cultural contexts, (ii) designs which employ active control groups, (iii) calculation of health economic benefits, (iv) identification of the optimal training duration, and (v) measurement of individual goal and quality of life outcomes. Method/design: With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12 to17 years (N=90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking program. Participants will attend both programs in groups of 6 to 8 adolescents, over 16 one and a half hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, and loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and health care costs. Discussion: The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents’ personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigours evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD.

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KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial

Trials ◽

10.1186/s13063-019-3721-9 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Bahareh Afsharnejad ◽

Marita Falkmer ◽

Melissa H. Black ◽

Tasha Alach ◽

Fabian Lenhard ◽

...

Keyword(s):

Quality Of Life ◽

Cost Effectiveness ◽

Active Control ◽

Randomized Control Trial ◽

Autism Spectrum ◽

Social Goals ◽

Control Group ◽

Active Control Group ◽

Randomized Control

Abstract Background Individuals diagnosed with autism spectrum disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (1) replication of effects in additional clinical and cultural contexts, (2) designs that employ active control groups, (3) calculation of health economic benefits, (4) identification of the optimal training duration, and (5) measurement of individual goals and quality of life outcomes. Method/design With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12–17 years (N = 90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking programme. Participants will attend both programmes in groups of 6–8 adolescents, over 16 one-and-a-half-hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via the Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, and emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and healthcare costs. Discussion The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents’ personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigorous evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12617001117303. Registered on 31 July 2017. anzctr.org.au ClinicalTrials.gov, NCT03294668. Registered on 22 September 2017. https://clinicaltrials.gov

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KONTAKT© in Australian Adolescents on the Autism Spectrum: Protocol of a Randomized Control Trial

10.21203/rs.2.326/v1 ◽

2019 ◽

Author(s):

Bahareh Afsharnejad ◽

Marita Falkmer ◽

Melissa H Black ◽

Tasha Alach ◽

Fabian Lenhard ◽

...

Keyword(s):

Quality Of Life ◽

Autism Spectrum Disorder ◽

Active Control ◽

Randomized Control Trial ◽

Autism Spectrum ◽

Social Goals ◽

Control Group ◽

Active Control Group ◽

Randomized Control

Abstract Background: Individuals diagnosed with Autism Spectrum Disorder (ASD) experience impairing challenges in social communication and interaction across multiple contexts. While social skills group training (SSGT) has shown moderate effects on various sociability outcomes in ASD, there is a need for (i) replication of effects in additional clinical and cultural contexts, (ii) designs which employ active control groups, (iii) calculation of health economic benefits, (iv) identification of the optimal training duration, and (v) measurement of individual goal and quality of life outcomes. Method: With the aim of investigating the efficacy and cost-effectiveness of a SSGT, KONTAKT©, a two-armed randomized control trial with adolescents aged 12 to17 years (N=90) with ASD and an intelligence quotient (IQ) of over 70 will be undertaken. Following stratification for centre and gender, participants will be randomly assigned to either KONTAKT© or to an active control group, a group-based cooking program. Participants will attend both programs in groups of 6 to 8 adolescents, over 16 one and a half hour sessions. The primary outcome examined is adolescent self-rated achievement of personally meaningful social goals as assessed via Goal Attainment Scaling during an interview with a blinded clinician. Secondary outcomes include adolescent self-reported interpersonal efficacy, quality of life, social anxiety, and loneliness, face emotion recognition performance and associated gaze behaviour, and parent proxy reports of autistic traits, quality of life, social functioning, emotion recognition and expression. Cost-effectiveness will be investigated in relation to direct and indirect societal and health care costs. Discussion: The primary outcomes of this study will be evidenced in the anticipated achievement of adolescents’ personally meaningful social goals following participation in KONTAKT© as compared to the active control group. This design will enable rigorous evaluation of the efficacy of KONTAKT©, exercising control over the possibly confounding effect of exposure to a social context of peers with a diagnosis of ASD. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617001117303, registered 31 July 2017, anzctr.org.au; ClinicalTrials.gov: NCT03294668 registered 22 September 2017, https://clinicaltrials.gov. Keywords: Social Skills, Adolescents, KONTAKT, Autism Spectrum Disorder, Training.

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Evaluating the effects of mindfulness-based stress reduction on cognitive function and quality of life in nondemented older adults : a pilot study.

10.32920/ryerson.14663457 ◽

2021 ◽

Author(s):

Sasha Mallya

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Pilot Study ◽

Executive Functioning ◽

Active Control ◽

Perceived Stress ◽

Stress Reduction ◽

Control Group ◽

Active Control Group

Adults over the age of 65 years are now the fastest growing segment of the Canadian population. Although individual differences exist, aging is commonly associated with impairments in executive function. The present pilot study investigated the effectiveness of a mindfulness-based stress reduction (MBSR) program on improving executive functioning in older adults, while additionally decreasing perceived stress and improving psychological wellbeing. It was hypothesized that compared with an active control group, the MBSR group would display significant improvements in executive functioning, mood, self-esteem, and perceived stress. Participants were randomly assigned to either MBSR (n=40) or an active control group (n=32). Results suggest that MBSR is associated with significantly enhanced quality of life compared with the control condition. No additional significant results were found. A full-scale study will be necessary to clarify the present results.

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EFFECTIVENESS OF HIGH AND LOW INTENSITY REHABILITATION PROGRAMME IN CHRONIC PHASE OF GUILLAIN BARRE SYNDROME PATIENTS: A RANDOMIZED CONTROL TRIAL

European Journal of Physiotherapy and Rehabilitation Studies ◽

10.46827/ejprs.v2i1.53 ◽

2021 ◽

Vol 2 (1) ◽

Author(s):

Gourav Kumar ◽

Lalit Arora ◽

Reena Arora

Keyword(s):

Quality Of Life ◽

Randomized Control Trial ◽

Self Care ◽

Chronic Phase ◽

Rehabilitation Programme ◽

Control Group ◽

Low Intensity ◽

Randomized Control ◽

Rehabilitation Exercises

Aim of the study: The aim of the study was to conduct a randomized control trial to compare the effectiveness of high and low intensity rehabilitation programme in chronic phase of GBS patient. Methodology: 20 Patients were included in the study as per inclusion and exclusion criteria. A written informed consent was signed by the subjects in their native language. The subjects were divided into two groups by simple random sampling. Group (A) Experimental Group (N=10): got treatment with High intensity rehabilitation exercises and Group (B) Control Group (N=10): got treatment with Low intensity rehabilitation exercises. Total rehabilitation program was for 12 months. The outcome measures for the both groups were Functional Independence Measure (FIM), World health Organization Quality of Life Scale (WHOQOL-BREF), Perceived Impact of Problem Profile (PIPP). Results: Intention to treat analysis of data from 20 patients (experimental n=10, control n=10) showed reduced disability in the treatment group in post-treatment FIM domains (self- care, sphincter control, transfers, locomotion; all p<0.001) and WHOQOL-BREF domains (quality of life; all p<0.001) and PIPP domains (self-care, mobility; all p<0.001). The treatment group compared with control group showed significant improvement in function (FIM scores): 72% vs. 50%. Conclusion: High intensity rehabilitation programme compared with Low intensity low intensity rehabilitation programme is effective in reducing motor disability (mobility, self-care, continence) in chronic phase of GBS patients. Article visualizations:<img src="/-counters-/edu_01/0720/a.php" alt="Hit counter" />

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Efficacy of Smartphone-based Application on Stress Reduction: a Randomized Control Trial (Preprint)

10.2196/preprints.28703 ◽

2021 ◽

Author(s):

Hyunchan Hwang ◽

Sun Mi Kim ◽

Bo Netterstrøm ◽

Doug Hyun Han

Keyword(s):

Quality Of Life ◽

Randomized Control Trial ◽

Intervention Group ◽

Smartphone Application ◽

Life Assessment ◽

World Health ◽

Control Group ◽

World Health Organization Quality ◽

Randomized Control

BACKGROUND Stress management within the workplace is important for a healthy mental and physical state. Due to technological advancements, individual-tailored therapy as well as online cognitive-behavioral therapy (CBT) is on the rise. OBJECTIVE This study analyzed the efficacy of a smartphone application based on third-wave CBT tailored to the individual. METHODS A randomized control trial was conducted on 126 participants who were divided into two groups. The intervention group used the smartphone application “BetterLife” for 10 weeks whilst the control group was put on a waiting list for the same duration. The Perceived Stress Scale-10 (PSS), Korean Utrecht Work Engagement Scale-9 (UWES), World Health Organization Quality of Life Assessment, abbreviated (WHOQOL), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI) were conducted at baseline and after 10 weeks in both groups. RESULTS Out of the 126 particiapnts, 11 dropped out during the trial. Two-way repeated measure analysis of covariance was conducted controlling for baseline BDI. There were greater improvements in PSS (F=24.33, P <.001, η2=0.17) and UWESK scores (F=8.32, P =.0046, η2=0.06) in the intervention group compared to the control group. WHOQOL scores exhibited statistically significance interactions in the intervention group in the overall quality of life (F=8.19, P =.0049, η2=0.06), and physical health (F= 8.87, P =.003, η2=0.07), psychological (F=13.32, P <.001, η2=0.10), social relationship (F= 19.43, P <.001, η2=0.14), and environmental domains (F= 10.14, P =.002, η2=0.08) but not in overall health (F= 1.68, P =.20). BDI showed a statistically significant improvement in the intervention group (F=7.17, P =.008, η2=0.06) as well as BAI (F=6.00, P =.02, η2=0.05), but this significance did not survive the Bonferroni’s correction (P <.005). CONCLUSIONS These results provide evidence that a smartphone application-based CBT is a viable option for reducing stress in the workplace. CLINICALTRIAL This trial has been registered in the Clinical Research Information Service (KCT0003231), a member of the WHO International Clinical Trials Registry Platform.

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Effectiveness of home-based electronic cognitive therapy in patients with Alzheimer’s disease dementia: A Feasibility Study (Preprint)

10.2196/preprints.34450 ◽

2021 ◽

Author(s):

Anna Marin ◽

Renée DeCaro ◽

Kylie Schiloski ◽

Ala’a Elshaar ◽

Brigid Dwyer ◽

...

Keyword(s):

Quality Of Life ◽

Active Control ◽

Cognitive Training ◽

Therapy Group ◽

Control Group ◽

Active Control Group ◽

Computerized Cognitive Training ◽

Home Based

BACKGROUND Can home-based computerized cognitive training programs be a useful tool to sustain cognition and quality of life in patients with Alzheimer’s disease (AD) dementia? Until now, the progressive nature of the disease and the variability in intervention periods has resulted in discrepant findings. We investigated a potential tool to offset the challenges usually found when evaluating the effectiveness of home-based computerized trainings in the AD population. Constant Therapy is a remotely-delivered, cloud-based program developed for patients with speech and cognitive deficits. OBJECTIVE We aimed to assess the feasibility and effectiveness of a 24-week individualized Constant Therapy intervention program in patients with AD in the MCI and mild dementia stages. METHODS Data were collected over a 48-week period. Participants were assigned to either the Constant Therapy or Active Control group. The Constant Therapy group completed an individualized tablet-based training during the first 24 weeks; the second 24 weeks of computerized training were optional. The Active Control group completed paper and pencil games (e.g., sudokus, crosswords) during the first 24 weeks, and then completed the Constant Therapy training during the second 24 weeks. At weeks 0, 24 and 48, participants completed a neuropsychological battery to assess changes in cognition and functioning. In addition, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was administered every 6 weeks. We measured Constant Therapy rate of adherence and task performance, as well as RBANS scores differences between the Constant Therapy and Active Control groups over the first 24 weeks of training. RESULTS Data for 19 patients were analyzed, with 44% of the Constant Therapy group and 22% of the Active Control group completing the entire 48-week training program. Due to the high drop-out rate, further analysis was only computed for participants who completed 24 weeks of training. The Constant Therapy group spent on average 121 days across the 24 weeks, and an average 27 minutes daily on the app. These participants showed an overall improvement in accuracy and latency in the Constant Therapy tasks scores, as well as specific improvements in the Constant Therapy tasks of visual and auditory memory, attention, and arithmetic. The Constant Therapy group also improved in the RBANS coding subtest compared to the Active Control group. CONCLUSIONS Long term (e.g., 24 weeks) computerized cognitive training using the Constant Therapy platform is feasible in patients with AD in the MCI and mild dementia stages. AD patients showed improvements on the Constant Therapy tasks over the 24 weeks and improved in one of the 12 RBANS subtests. These findings support the need for future research investigating the effects of long term individualized computerized programs as tools to sustain cognitive function and potentially quality of life in patients with AD. CLINICALTRIAL ClinicalTrials.gov NCT02521558

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Evaluating the effects of mindfulness-based stress reduction on cognitive function and quality of life in nondemented older adults : a pilot study.

10.32920/ryerson.14663457.v1 ◽

2021 ◽

Author(s):

Sasha Mallya

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Pilot Study ◽

Executive Functioning ◽

Active Control ◽

Perceived Stress ◽

Stress Reduction ◽

Control Group ◽

Active Control Group

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Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05228-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Ye ◽

Dawei Zhu ◽

Siyuan Chen ◽

Xuefeng Shi ◽

Rui Gong ◽

...

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Cost Effectiveness ◽

Treatment Group ◽

Hearing Aids ◽

Control Group ◽

Chinese Adults ◽

Community Based ◽

The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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