The Effects of a Multitiered System of Language Support on Kindergarten Oral and Written Language: A Large-Scale Randomized Controlled Trial

2021 ◽  
pp. 1-25
Author(s):  
Douglas B. Petersen ◽  
Maureen Staskowski ◽  
Trina D. Spencer ◽  
Matthew E. Foster ◽  
Mollie Paige Brough
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Written Language ◽  
Tier 2 ◽  
Language Support ◽  
Randomized Controlled ◽  
Personal Stories ◽  
Tier 1 ◽  
Tier 2 Intervention

Purpose: The purpose of this randomized controlled trial was to examine the effects of a multitiered system of language support (MTSLS) on kindergarteners' narrative retelling, personal stories, writing, and expository language. Method: Participants were 686 kindergarten students from four school districts in the United States. Twenty-eight classrooms were randomly assigned to treatment ( n = 337 students) or control ( n = 349 students) conditions. The treatment group received 14 weeks of oral narrative language instruction using Story Champs, a multitiered language program. Classroom teachers delivered large group (Tier 1) instruction for 15–20 min a day for 4 weeks. After this short-duration whole-class instruction, speech-language pathologists began small group Story Champs (Tier 2) intervention with a random sample of students who did not make adequate progress from the large group instruction ( n = 49). These students received Tier 2 intervention for 20 min twice a week in addition to continued Tier 1 instruction. Results: Results indicated that the students in the treatment group had significantly higher scores on all outcome measures compared to the students in the control group. Analyses of outcomes from the 49 students who received Tier 2 intervention compared to a matching sample of at-risk control students revealed that the treatment group had significantly higher scores on narrative retells, personal stories, and expository retells. When compared to matched average-performing and advanced-performing control peers, the students who received Tier 2 intervention had significantly higher narrative retell scores and no longer had significantly lower personal story, expository, or writing scores. Conclusion: This effectiveness study demonstrated that MTSLS can lead to meaningful improvements in kindergarteners' oral and written language skills, even helping at-risk students catch up to high-achieving peers.

scholarly journals Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial

2019 ◽  
Vol 41 (6) ◽  
pp. 631-640
Author(s):  
Johanna Julku ◽  
Kirsi Pirilä-Parkkinen ◽  
Mimmi Tolvanen ◽  
Pertti Pirttiniemi
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Class Ii ◽  
Class Ii Malocclusion ◽  
Gonial Angle ◽  
Randomized Controlled ◽  
Face Height ◽  
Upper Face ◽  
Facial Changes

Summary Background There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting. Objectives The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered. Trial design Prospective, parallel-group, randomized controlled trial. Methods Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation. Results Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N–ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL–PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0–T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered. Conclusions Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered. Clinical registration ClinicalTrials.gov (NCT02010346).

scholarly journals The Impact of Fresh Hass Avocado on the Fecal Metabolome Among Adults with Overweight and Obesity: A Randomized, Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1593-1593
Author(s):  
Sharon Thompson ◽  
Ziyang Pan ◽  
Caitlyn Edwards ◽  
Ginger Reeser ◽  
Naiman Khan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Type I ◽  
Gastrointestinal Microbiota ◽  
Randomized Controlled ◽  
Food And Agriculture ◽  
Hass Avocado ◽  
The Impact

Abstract Objectives Avocados are nutrient-rich fruits that have been recently linked to beneficial alterations to the gastrointestinal microbiota. However, previous research on shifts in the fecal metabolome with avocado intake has largely been conducted in in vitro or preclinical models and little is known about their metabolomic impact in human subjects. Methods Adult participants (n = 109) 25–45 years of age with BMI ≥ 25.0 kg/m2 were enrolled in an investigator-blinded, parallel arm, randomized, controlled trial. Participants consumed isocaloric meals with or without fresh Hass avocado once daily for 12-weeks and reported ≥ 80% meal consumption over the intervention period. Untargeted fecal metabolites were quantified in a subsample of participants (n = 48) using gas chromatography mass spectroscopy and were normalized by sample weight. Kruskal-Wallis tests and false discovery rate type I error correction were conducted and orthogonal partial least squares discriminant analysis (OPLS-DA) was used to predict treatment group by fecal metabolite concentrations (RStudio, version 3.6.2). Results A total of 292 metabolites were identified at intervention follow-up. Of these, three metabolites differed significantly between treatment groups. Fecal concentrations of lanosterol (P = 0.0004, q = 0.04) and the fatty alcohols hexadecanol (P = 0.001, q = 0.04) and octadecanol (P = 0.001, q = 0.04), were greater in the group consuming avocado as compared to control. Seventeen additional metabolites, including nine fecal lipids, two fat soluble vitamin derivatives, and three monosaccharides/disaccharides differed at P &lt; 0.05 but did not meet the q &lt; 0.05 threshold. Treatment group assignment was predicted correctly in 70% of cases (R2 = 72%, Q2 = 33%) using the trained OPLS-DA model. Conclusions Fresh Hass avocado intake increased fecal lipid and sterol concentrations among healthy adults with overweight and obesity, demonstrating diet-related modifications to the fecal metabolome. Funding Sources Support for this research was provided by the Hass Avocado Board, the USDA National Institute of Food and Agriculture, Hatch project 1009249, and the USDA National Institute of Food and Agriculture AFRI Predoctoral Fellowship, project 2018–07785.

scholarly journals The Effect of Ursodeoxycholic Acid on Small Intestinal Bacterial Overgrowth in Patients with Functional Dyspepsia: A Pilot Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1410
Author(s):  
Bom-Taeck Kim ◽  
Kwang-Min Kim ◽  
Kyu-Nam Kim
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Ursodeoxycholic Acid ◽  
Controlled Trial ◽  
Bacterial Overgrowth ◽  
Small Intestinal Bacterial Overgrowth ◽  
Treated Group ◽  
Randomized Controlled ◽  
Intestinal Bacterial Overgrowth ◽  
Small Intestinal

Functional dyspepsia (FD) is associated with small intestinal bacterial overgrowth (SIBO). Several animal studies have reported that ursodeoxycholic acid (UDCA) has antibacterial and anti-inflammatory effects in the intestine. We hypothesized that UDCA may be effective against dyspeptic symptoms and SIBO in patients with FD. We conducted this randomized controlled trial to investigate the effects of UDCA in FD patients with SIBO. Twenty-four patients diagnosed with FD and SIBO based on lactulose breath test (LBT) were randomly assigned to either a UDCA treatment group or an untreated group. The treatment group received 100 mg of UDCA three times per day for two months; the untreated group was monitored for two months without intervention. After two months in both groups, we reevaluated LBT and FD symptoms using the Nepean dyspepsia index-K. FD symptoms in the UDCA-treated group were significantly reduced after two months compared with baseline and FD symptom scores between the UDCA-treated and untreated groups showed statistically significant differences after two months. In addition, the total methane gas levels for 90 minutes in LBT were significantly decreased after two months compared with baseline in the UDCA-treated group. In this preliminary exploratory study, we found that two months of UDCA treatment resulted in FD symptom improvement and reduced methane values during 90 minutes on the LBT, suggesting that methane-producing SIBO were associated with symptoms of dyspepsia and that UDCA was helpful in these patients. These findings need to be validated via large-scale controlled and well-designed studies.

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (7 Supple B) ◽  
pp. 91-97 ◽  
Author(s):  
David A. Crawford ◽  
Adolph V. Lombardi ◽  
Keith R. Berend ◽  
James I. Huddleston ◽  
Christopher L. Peters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Urgent Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

scholarly journals Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Mi Li ◽  
Lijuan Zhao ◽  
Li Ma ◽  
Wen Zhang ◽  
Hua Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Oral Solution ◽  
Controlled Study ◽  
Symptom Improvement ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.

scholarly journals Efficacy and Safety of Inhaled Ciclesonide in Treating Patients With Asymptomatic or Mild COVID-19 in the RACCO Trial: Protocol for a Multicenter, Open-label, Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Junko Terada-Hirashima ◽  
Manabu Suzuki ◽  
Yukari Uemura ◽  
Masayuki Hojo ◽  
Ayako Mikami ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Symptomatic Treatment ◽  
Open Label ◽  
Exacerbation Rate ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Computed Tomography Images ◽  
Study Results

BACKGROUND Currently, there are no specific effective treatments for SARS-CoV-2 infection; however, various COVID-19 treatment options are under investigation. It is vital to continue investigating the landscape of SARS-CoV-2–induced pneumonia and therapeutic interventions. OBJECTIVE This paper presents the protocol for a randomized controlled trial that aims to compare the pneumonia exacerbation rate between ciclesonide (ALVESCO; Teijin Pharma Limited) administration and symptomatic treatment in patients with COVID-19 and to determine the efficacy of ciclesonide. The secondary objectives are to investigate the safety of ciclesonide administration, changes in clinical and laboratory findings, and the number of viral genome copies of SARS-CoV-2 over time between the 2 groups. METHODS In this investigator-initiated, exploratory, prospective, multicenter, parallel-group, open-label, randomized controlled trial, a total of 90 patients diagnosed with COVID-19 will be recruited from 21 hospitals in Japan based on specific inclusion and exclusion criteria. Participants will be randomized either to the ciclesonide group, which will receive a 400-µg dose of ciclesonide 3 times per day over a 7-day period, or to the symptomatic treatment group. Both groups will receive antitussives and antipyretics as required. Data collection for various parameters will be conducted on days 1, 2, 4, 8, 22, and 29 to record baseline assessments and the findings over an extended period. Computed tomography images taken prior to drug administration and 1 week following treatment will be compared, and efficacy will be confirmed by checking for pneumonia exacerbation. Primary endpoint analysis will be performed using the Fisher exact test to determine statistically significant differences in the pneumonia exacerbation rate between the ciclesonide and symptomatic treatment groups. RESULTS The first trial participant was enrolled on April 3, 2020. Recruitment is expected to be completed on September 30, 2020, while follow-up assessments of all participants are expected to be completed by October 31, 2020. The study results will be published in a peer-reviewed scientific journal. CONCLUSIONS The RACCO (Randomized Ciclesonid COVID-19) study will provide definitive comparative effectiveness data and important clinical outcomes data between the ciclesonide and symptomatic treatment groups. If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide will serve as an important therapeutic option for patients with COVID-19. CLINICALTRIAL Japan Registry of Clinical Trials jRCTs031190269; https://jrct.niph.go.jp/en-latest-detail/jRCTs031190269 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23830

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

2013 ◽  
Vol 44 (10) ◽  
pp. 2213-2222 ◽  
Author(s):  
S. Salzer ◽  
C. Cropp ◽  
U. Jaeger ◽  
O. Masuhr ◽  
A. Streeck-Fischer
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Academic Failure ◽  
Psychodynamic Therapy ◽  
Post Treatment ◽  
Control Group ◽  
Global Severity Index ◽  
Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

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