scholarly journals Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Krister W. Fjermestad ◽  
Wendy K. Silverman ◽  
Torun M. Vatne
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Family Communication ◽  
Neurodevelopmental Disorders ◽  
Group Intervention ◽  
Controlled Trial ◽  
Evidence Based ◽  
Post Intervention ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based. Methods We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings’ understanding of the neurodevelopmental disorder, siblings’ emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022. Discussion SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention. Trial registration ClinicalTrials.gov NCT04056884. Registered in August 2019

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AC-Training) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AC-Training will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AC-Training successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

scholarly journals Confounding in Observational Studies Explained

2012 ◽  
Vol 5 (1) ◽  
pp. 18-20 ◽  
Author(s):  
Bikaramjit Mann ◽  
Evan Wood
Keyword(s):  
Randomized Controlled Trial ◽  
Health Information ◽  
Observational Studies ◽  
Controlled Trial ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Disease Outcomes ◽  
Different Types ◽  
Based Medicine ◽  
The Impact

Practical and ethical constraints mean that many clinical and/or epidemiological questions cannot be answered through the implementation of a randomized controlled trial. Under these circumstances, observational studies are often required to assess relationships between certain exposures and disease outcomes. Unfortunately, observational studies are notoriously vulnerable to the effect of different types of “confounding,” a concept that is often a source of confusion among trainees, clinicians and users of health information. This article discusses the concept of confounding by way of examples and offers a simple guide for assessing the impact of is effects for learners of evidence-based medicine.

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91 ◽  
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AffeCT) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AffeCT will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AffeCT successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial

2021 ◽  
pp. 135245852110468
Author(s):  
Michelle H Cameron ◽  
Andrea Hildebrand ◽  
Cinda L Hugos ◽  
Grace I Judd ◽  
Garnett McMillan ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Credible Intervals ◽  
Falls In Older Adults ◽  
The Impact

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. Methods: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. Results: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8–2.0) and 1.4 falls/month in the control group (95% CI = 0.9–2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4–6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4–0.9); control 0.8 falls/month (95% CI = 0.5–1.1)). Conclusion: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals The Impact of Shorter, More Frequent Outdoor Play Periods on Preschoolers’ Physical Activity during Childcare: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (21) ◽  
pp. 4126 ◽  
Author(s):  
Molly Driediger ◽  
Stephanie Truelove ◽  
Andrew M. Johnson ◽  
Leigh M. Vanderloo ◽  
Brian W. Timmons ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Outdoor Play ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Children’s physical activity levels are higher at the start of outdoor playtime, which suggests that shorter, more frequent play periods might result in greater amounts of daily physical activity. In this extension of the Supporting Physical Activity in the Childcare Environment (SPACE) cluster randomized controlled trial, we explored the impact of four 30-min daily outdoor unstructured play periods on preschoolers’ moderate-to-vigorous-intensity physical activity (MVPA). Experimental childcare centres (n = 6) implemented four 30-min daily outdoor playtimes for 8 weeks, while control centres (n = 6) maintained their two 60-min outdoor sessions. Actical™ accelerometers were used to measure preschoolers’ physical activity pre- and post-intervention for 5 days during childcare hours. Linear mixed effects models were used to determine the impact of the intervention on preschoolers’ MVPA. Of the 185 preschoolers enrolled (54.20% female; mean age = 39.90 months, SD = 7.24), 127 (65 experimental and 62 control) were included in the analysis (30% and 9% loss to follow-up for experimental and control group preschoolers, respectively). No significant differences in MVPA were observed between groups over time (p = 0.36). Preschoolers’ MVPA did not improve after the introduction of shorter outdoor play periods. The loss of data due to wear time noncompliance and participant attrition may have influenced these findings. Trial registration: ISRCTN70604107 (October 8, 2014).

scholarly journals Weekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Lyndel Hewitt ◽  
Samantha Stephens ◽  
Abbe Spencer ◽  
Rebecca M. Stanley ◽  
Anthony D. Okely
Keyword(s):  
Randomized Controlled Trial ◽  
Motor Development ◽  
Group Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Time Duration ◽  
Randomized Controlled ◽  
Tummy Time

Abstract Background The World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion. Methods The aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother’s groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen’s d statistic. Results Recruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen’s d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants. Conclusion Group tummy time classes delivered in a mother’s group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted. Trial registration ANZCTR, ACTRN12617001298303p. Registered 11 September 2017

scholarly journals The Effect of Providing Free Eyeglasses on Children’s Mental Health Outcomes in China: A Cluster-Randomized Controlled Trial

2018 ◽  
Vol 15 (12) ◽  
pp. 2749 ◽  
Author(s):  
Hongyu Guan ◽  
Huan Wang ◽  
Kang Du ◽  
Jin Zhao ◽  
Matthew Boswell ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Rural China ◽  
Controlled Trial ◽  
Poor Mental Health ◽  
School Students ◽  
Randomized Controlled ◽  
Learning Anxiety ◽  
Cluster Randomized ◽  
The Impact

If children with common vision problems receive and use eyeglasses, their educational performance rises. Without proper treatment, visually impaired children may not achieve educational gains and could suffer from poor mental health. We use a randomized controlled trial to study the impact of an eyeglasses promotion program in rural China on the mental health of myopic primary school students. Three measures of mental health are used: learning anxiety, physical anxiety, and scores on the Mental Health Test (MHT). Our empirical analysis showed that on average, the treatment has small and insignificant for learning anxiety and MHT, and a small but significant reduction in physical anxiety. However, subgroup analysis reveals that myopic students who study more intensively see their learning anxiety and physical anxiety reduced after being provided with eyeglasses. In contrast, students with the lower study intensity suffer a rise in learning anxiety after receiving eyeglasses. A potential mechanism for the differing impacts is the increase in teasing reported among low study-intensity students that does not occur for high study-intensity students. Care should be taken to maximize the benefits and minimize the costs of in-school vision programs.

Sign in / Sign up

Export Citation Format

Share Document