DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

2021 ◽  
pp. 136749352110037
Author(s):  
Alison E. Parker ◽  
Tracy M. Scull ◽  
Abigail M. Morrison
Keyword(s):  
Clinical Trials ◽  
Interactive Multimedia ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Satisfaction Questionnaire ◽  
Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

scholarly journals A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bettina Wollesen ◽  
Madeleine Fricke ◽  
Carl-Philipp Jansen ◽  
Katharina Gordt ◽  
Michael Schwenk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Spatial Orientation ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Abstract Background In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents. Methods A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated. Discussion This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations. Trial registration The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).

scholarly journals Internet-Delivered Cognitive Behavior Therapy for Young Taiwanese Female Nursing Students with Irritable Bowel Syndrome—A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (5) ◽  
pp. 708 ◽  
Author(s):  
Tzu-Ying Lee ◽  
Tsung-Cheng Hsieh ◽  
Huei-Chuan Sung ◽  
Wan-Lan Chen
Keyword(s):  
Nursing Students ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Irritable Bowel

Irritable Bowel Syndrome (IBS) is prevalent within the general population. Studies have shown that stress and anxiety co-exist with IBS. Young Taiwanese women commonly exhibit physical and psychological health problems caused by academic stress. The purpose of our current study was to evaluate the efficacy of short-term Internet-delivered cognitive-behavioral therapy (ICBT) on female nursing students in practicum. We performed a cluster randomized controlled trial comprised of 160 participants who met the inclusion criteria, which were divided into three groups: (1) ICBT, (2) expressive writing (EW), and (3) wait-list control. Treatment interventions lasted for 6 weeks. Levels of anxiety, depression, and IBS symptoms were assessed at four time points, baseline assessment at T0, 2 weeks after T0 (T1), at the end of practicum (T2), and at 3-month follow-up (T3). The results showed that ICBT and EW groups exhibited a significant, yet small, reduction in anxiety and depression at T2 and T3 compared to the wait-list control group. The EW group exhibited significantly greater reduction in anxiety and depression compared to the ICBT group at T2. However, the ICBT group demonstrated greater improvements in alleviating anxiety and depression at T3 compared to the EW group. These data indicate that ICBT and EW groups exhibited small effects on anxiety and depression reduction at T2 and T3 compared to the wait-list control group, with no effects on IBS symptoms in young Taiwanese female nursing students.

scholarly journals The self-esteem booster: A randomized controlled trial investigating a mobile-based intervention in students with depressive symptoms (Preprint)

2020 ◽  
Author(s):  
Alina Bruhns ◽  
Thies Lüdtke ◽  
Steffen Moritz ◽  
Lara Bücker
Keyword(s):  
Depressive Symptoms ◽  
Intervention Group ◽  
Self Esteem ◽  
The Self ◽  
Smartphone App ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Self Help

BACKGROUND Depressive symptoms are one of the most common and ever increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need for help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap. OBJECTIVE In the framework of a randomized controlled trial, we investigated the effectiveness, acceptance and side effects of a self-help smartphone app (MCT & More) based on techniques of cognitive behavioral therapy (CBT), mindfulness, acceptance and commitment therapy, and metacognitive training (MCT) in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes towards internet- and mobile-based interventions on treatment adherence and effectiveness. METHODS A total of 400 students were recruited via open access websites and randomized to either the intervention group (n = 200), who received access to the self-help smartphone app "MCT & More" for a period of four weeks, or to a wait list control group (n = 200). The PHQ-9 (depression) served as primary outcome parameter, the RSE (self-esteem) and the global item of the WHOQOL-BREF (quality of life) as secondary outcome parameters. The APOI was used to measure attitudes towards internet- and mobile-based interventions. Outcome expectations were assessed with the PATHEV and side effects with the INEP. RESULTS Per-protocol (PP), complete-case (CC) and intention-to-treat (ITT) analyses showed a significantly higher reduction in depressive symptoms (PP: F(1,222) = 3.98, P = .047, d = .26) and a significantly higher increase in self-esteem (PP: F(1,220) = 8.79, P = .003, d = .77) within the intervention group compared to the wait list control group. Most participants used the self-help smartphone app regularly (76 % at least once a week). The more positive the attitude towards internet- and mobile-based interventions (r = .260, P = .004) and the more positive the outcome expectation (r = .236, P = .009), the more frequently the self-help smartphone app was used. CONCLUSIONS The effectiveness of the self-help smartphone app "MCT & More" was demonstrated among students with depressive symptoms compared to a wait list control group. The app could be offered regularly as a low-threshold intervention to enhance students' health. CLINICALTRIAL German Clinical trials Register (DRKS00020941); https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020941

Mindfulness-based intervention and aggression and rule-breaking behaviours in elementary school boys: a proof of concept trial

2021 ◽  
pp. 1-8
Author(s):  
Maedeh Heidary ◽  
Touraj Hashemi Nosrat Abad ◽  
Wolfgang Linden
Keyword(s):  
Elementary School ◽  
Child Behavior Checklist ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Externalising Disorders ◽  
Rule Breaking

Abstract This study investigated the effect of a mindfulness-based intervention on pathological symptoms in boys with externalised disorders. A total of 24 elementary school students with externalising disorders, diagnosed by completing the Child Behavior Checklist (CBCL), were randomly assigned to a mindfulness-based intervention for two months. One session per week was offered and each session lasted one hour (n = 12) or as a wait-list control group (n = 12). Data were analysed via a multivariate analysis of covariance (MANCOVA) test. Students from the intervention group showed greater reductions in rule-breaking behaviours than those in the wait-list control group. Also, there was clear superiority of the intervention relative to the wait-list control group for reducing both aggression and rule-breaking behaviours (effect size differences were d = −2.52 and d = −1.88 respectively). These positive results on outcome measures provide initial evidence for a mindfulness-based intervention as a treatment option for boys with externalising disorders.

scholarly journals The Effectiveness of an Integrated Treatment for Functional Speech Sound Disorders—A Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. 1190
Author(s):  
Denise I. Siemons-Lühring ◽  
Harald A. Euler ◽  
Philipp Mathmann ◽  
Boris Suchan ◽  
Katrin Neumann
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Speech Sound ◽  
Control Group ◽  
Wait List ◽  
Speech Sound Disorders ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Background: The treatment of functional speech sound disorders (SSDs) in children is often lengthy, ill-defined, and without satisfactory evidence of success; effectiveness studies on SSDs are rare. This randomized controlled trial evaluates the effectiveness of the integrated SSD treatment program PhonoSens, which focuses on integrating phonological and phonetic processing according to the Integrated Psycholinguistic Model of Speech Processing (IPMSP). Methods: Thirty-two German-speaking children aged from 3.5 to 5.5 years (median 4.6) with functional SSD were randomly assigned to a treatment or a wait-list control group with 16 children each. All children in the treatment group and, after an average waiting period of 6 months, 12 children in the control group underwent PhonoSens treatment. Results: The treatment group showed more percent correct consonants (PCC) and a greater reduction in phonological processes after 15 therapy sessions than the wait-list control group, both with large effect sizes (Cohen’s d = 0.89 and 1.04). All 28 children treated achieved normal phonological abilities: 21 before entering school and 7 during first grade. The average number of treatment sessions was 28; the average treatment duration was 11.5 months. Conclusion: IPMSP-aligned therapy is effective in the treatment of SSD and is well adaptable for languages other than German.

scholarly journals A Digital Intervention to Alleviate Loneliness and Depression Among Older Persons During the COVID-19 Outbreak

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 933-934
Author(s):  
Stav Shapira ◽  
Ella Cohn-Schwartz ◽  
Daphna Yeshua-Katz ◽  
Limor Aharonson-Daniel ◽  
A Mark Clarfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Older Adults ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Post Intervention ◽  
Wait List Control

Abstract Social distancing has been proven to be effective in reducing infections but may cause ill effects on the mental health of older adults. We evaluated the effects of a short-term virtual group intervention that provided tools to promote better coping, and mitigate adverse mental health effects during the outbreak of the covid-19 pandemic. A Randomized controlled trial tested the effects of a guided intervention comprised of seven online group sessions in which cognitive-behavioral techniques targeting maladaptive beliefs and appraisals were learned and practiced via ZOOM. A total of 82 community-dwelling adults from Israel, aged between 65 - 90 were randomized to either an intervention group (n=64) or a wait-list control group (n=18). Loneliness (UCLA loneliness scale) and depressive symptoms (PHQ-9) were measured pre-intervention, post-intervention, and at 1-month follow-up. The findings showed a significant decrease in loneliness and depression scores in the intervention group with results maintained at 1-month follow-up. There were no significant changes in the wait-list control group. In addition, ten participants (16%) from the intervention group demonstrated a clinically meaningful decrease in depression between baseline and post-intervention, and this was maintained among 7 participants (10%) at 1-month follow-up, compared to only 1 participant (5%) in the control group. Our intervention presents a simple and easy-to-implement tool. Its relevance extends beyond the current pandemic as the skills acquired can be applied in other forms of social crises and during routine life, in order to promote the mental health of older adults who live alone and/or reside in remote areas.

scholarly journals Feasibility and Preliminary Efficacy of Tailored Yoga in Survivors of Head and Neck Cancer: A Pilot Study

2018 ◽  
Vol 17 (3) ◽  
pp. 774-784 ◽  
Author(s):  
Melissa Adair ◽  
Barbara Murphy ◽  
Sujatha Yarlagadda ◽  
Jie Deng ◽  
Mary S. Dietrich ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Late Effects ◽  
Intervention Group ◽  
Hatha Yoga ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Efficacy Data ◽  
Wait List Control

Purpose: Treatment for head and neck cancer (HNC) results in long-term toxicities and increased physical and psychosocial survivor burden. There are a limited number of treatments for these late effects. Yoga postures, breath work, relaxation, and meditation, may improve these late effects. The purpose of this study was to examine the feasibility of a tailored yoga program in HNC survivors and obtain preliminary efficacy data. Methods: This was a randomized wait-list control study of yoga-naive HNC survivors who were >3 months post–cancer treatment. Baseline data were collected. Participants were randomized to either an 8-week hatha yoga intervention group or a wait-list group. Feasibility and efficacy data were collected. At 4 and 8 weeks, patients underwent a repeat assessment of health. Wait-list control group participants were offered the yoga program after data collection. Descriptive statistics evaluated feasibility. Mixed effects general linear models were used to generate estimates of the efficacy outcomes. Results: Seventy-three individuals were screened and 40 were eligible. All eligible individuals consented and enrolled. Five of the intervention group discontinued early and none in the wait-list control group. Feasibility was affirmed as participants were recruited and retained in the study, there were no adverse events, fidelity to protocol was demonstrated, and satisfaction rates were high. Efficacy measures indicated potential benefit for shoulder range of motion ( d = 0.57-0.86, P < .05), pain ( d = 0.67-0.90, P ≤ .005), and anxiety ( d = 0.59, P = .015). Conclusion: A tailored hatha yoga program is feasible and potentially efficacious for HNC survivors. Preliminary data supports further investigation of yoga in this population is needed.

The Effects of Family-Based Mindfulness Intervention on ADHD Symptomology in Young Children and Their Parents: A Randomized Control Trial

2017 ◽  
Vol 24 (5) ◽  
pp. 667-680 ◽  
Author(s):  
Herman H. M. Lo ◽  
Simpson W. L. Wong ◽  
Janet Y. H. Wong ◽  
Jerf W. K. Yeung ◽  
Eline Snel ◽  
...  
Keyword(s):  
Intervention Group ◽  
Well Being ◽  
Medium Effect ◽  
Control Group ◽  
Wait List ◽  
Adhd Symptoms ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Mindfulness Intervention ◽  
Family Based

Objective: The aim of the study is to investigate the feasibility of a family-based mindfulness intervention in improving children with inattention and hyperactivity symptoms. Method: A total of 100 children aged 5 to 7 years with ADHD symptoms and their parents were randomly assigned to a family-based mindfulness intervention ( n = 50) or a wait-list control group ( n = 50). Results: Families from intervention group had greater improvements in children’s ADHD symptoms, with medium effect sizes of −0.60 for inattention and −0.59 for hyperactivity; overall behaviors; and parenting stress and well-being than those in wait-list control group. Conclusion: The positive results on the child primary outcome measures have provided initial evidence of the family-based mindfulness intervention as a treatment option to ADHD. The reduction of parental stress and increase in psychological well-being has demonstrated the value of mindfulness in enhancing parent’s self-management.

scholarly journals Cultivating mindfulness: evaluation of a community-based mindfulness program for Arabic-speaking women in Australia

2021 ◽  
Author(s):  
Ilse Blignault ◽  
Hend Saab ◽  
Lisa Woodland ◽  
Cathy O’Callaghan
Keyword(s):  
Intervention Group ◽  
Community Setting ◽  
Mindfulness Practice ◽  
Sign Test ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Paired Samples ◽  
Arabic Speaking

AbstractArabic-speaking communities in Australia underutilise mental health services. Previous research with Arabic-speakers recruited individually demonstrated that an Arabic Mindfulness Compact Disc (CD) was an acceptable and useful resource for this group. Subsequently, the CD was introduced as part of a 5-week group mindfulness program for Arabic-speaking Muslim women. The intervention was delivered in a community setting by a bilingual (Arabic/English) psychologist with support from a bilingual multicultural health worker. The mixed-methods evaluation incorporated a pre–post study with a wait-list control group. An Arabic translation of the Depression Anxiety and Stress Scale (DASS21) was administered at baseline and program completion. Pre–post differences were tested using the sign test for paired samples (one-sided). Qualitative methods were used to evaluate the program’s acceptability. After five weeks, the intervention group showed statistically significant improvement on all DASS21 subscales (n = 12, p < .001 for depression and stress and p < .01 for anxiety). For the wait-list control group, only anxiety showed significant improvement (n = 8, p < .05). Qualitative analysis revealed how the women grew in their understanding of mindfulness concepts and mastered the different techniques, how they dealt with painful memories, how mindfulness practice assisted them in their daily lives, and how they related mindfulness to Islam. The in-language mindfulness intervention was shown to be culturally and spiritually relevant, and clinically effective. The group program incorporating the Arabic Mindfulness CD has potential for scaling up. Further research is required to investigate effectiveness for Arabic-speaking men with similar backgrounds.

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