Withdrawal Design Research Articles

Tootling With a Randomized Independent Group Contingency to Improve High School Classwide Behavior

The present study examined the effects of tootling, a peer-mediated positive behavior intervention, on students’ classwide disruptive and academically engaged behavior in three general education high school classrooms. A withdrawal design was used to assess the effects of the intervention. Students wrote tootles anonymously on paper slips and placed them into a marked container. A randomized independent group contingency was used to reward students. At the end of the class period, teachers randomly drew three of the submitted tootles and rewarded students about whom the tootles were written. Teachers also randomly drew the names of two students who submitted a tootle and rewarded them as well. All three classrooms displayed decreases in classwide disruptive behavior and increases in academically engaged behavior during intervention phases. Effect size calculations for both disruptive and academically engaged behavior indicated very large overall effects. The results of this study suggest that a modified tootling procedure utilizing a randomized independent group contingency can be an effective intervention for teachers to improve the classwide behavior of students in high school classrooms. Teachers found the intervention at least moderately socially valid and students rated it highly acceptable.

The Effects of Text-to-Speech on Reading Outcomes for Secondary Students With Learning Disabilities

This study investigated the effectiveness of text-to-speech (TTS) on the outcomes of reading comprehension and oral reading fluency (ORF) for four secondary students with learning disabilities. The researchers used a single-case A–B–A–B withdrawal design to evaluate the effectiveness of TTS on reading outcomes. All participants scored higher on reading comprehension after using TTS when reading instructional passages and maintained the skills for 4 weeks. Results on participants’ ORF also indicated an increased level of words read per min at the end of each accommodation condition. Comparison of pre- and posttest achievement on the Lexile assessment showed that two of the four participants increased their reading scores. Major findings are discussed with implications for practice and recommendations for future research to increase the use of TTS in the classroom.

Determinants of antidepressant response: Implications for practice and future clinical trials

BackgroundResponse to antidepressants in major depressive disorder is variable and determinants are not well understood or used to design clinical trials. We aimed to understand these determinants. MethodsSupported by Innovative Medicines Initiative, as part of a large public-private collaboration (NEWMEDS), we assembled the largest dataset of individual patient level information from industry sponsored randomized placebo-controlled trials of antidepressant drugs in adults with MDD. We examined patient and trial-design-related determinants of outcome as measured by change on Hamilton Depression Scale or Montgomery–Asberg Depression Rating Scale in 34 placebo-controlled trials (drug, n = 8260; placebo, n = 3957). ResultsWhile it is conventional for trials to be 6–8 weeks long, drug-placebo differences were nearly the same at week 4 as at week 6 and with lower dropout rates. At the multivariate level, having any of these attributes was significantly associated with greater drug vs. placebo differences on symptom improvement: female, increasing proportion of patients on placebo, centers located outside of North America, centers with low placebo response (regardless of active treatment response) and using randomized withdrawal designs. LimitationsData on compounds that failed were not available to us. Findings may not be relevant for new mechanisms of action. ConclusionsProof of concept trials can be shorter and efficiency improved by selecting enriched populations based on clinical and demographic variables, ensuring adequate balance of placebo patients, and carefully selecting and monitoring centers. In addition to improving drug discovery, patient exposure to placebo and experimental treatments can be reduced.

The study aimed to investigate the effectiveness of implementing flipped Class Strategy in teaching my beautiful language on developing the academic achievement of the sixth grade students in the Kingdom of Saudi Arabia by comparing it with the usual meth: فعالية استراتيجية الثناء لتحسين سلوك إتمام المهمة لدى ذوي اضطراب الانتباه والنشاط الزائد في مرحلة رياض الأطفال

This study aimed to examine the effectiveness of using praise as an intervention to improve on- task behavior of preschoolers with Attention Deficit- Hyperactivity/Disorder (ADHD) . Participants of the study were five children (3 males and 2 females) ; two of them diagnosed with ADHD, and three of them were identified by their teachers as at risk of having ADHD. All participants were enrolled in a regular class at King Saud University kindergarten in Riyadh. The study was conducted in classroom setting the setting is a teacher- directed activity in which the teacher teach children some tasks. Two designs of Single Subject Designs (SSD) used in this study. The designs used are: A- B- A- B Withdrawal Design, and Multiple Baseline Designs across Participants. The researcher provide teachers with a workshop on praise strategy. Then she asked them to use the strategy, and assist them with children praise when needed. Data were collected by the researcher and two researcher assistants using direct observation. Behaviors were observed in the teacher- directed activity setting throughout several phases: baseline, implementation of the intervention, withdrawal of the intervention, reimplementation of the intervention, and follow- up; while in the open activity setting behaviors were observed in two phases: baseline and implementation of the intervention. Results of the study showed that there is a positive functional relationship between using praise and on- task behavior of preschoolers with ADHD.

Implementing Stay-Play-Talk With Children Who Use AAC

Withdrawal and multitreatment single subject research designs were used to evaluate the effectiveness of stay-play-talk (SPT) interventions on social behaviors of preschool-aged peers to children with disabilities. Each group included at least one socially competent peer and one child with Down syndrome who used an augmentative and alternative communication (AAC) device as a primary mode of communication. Peers were trained to use SPT strategies during free play sessions, and a modified reinforcement system and modified peer arrangement were introduced for one group. For one group, results indicate a functional relation between the original SPT intervention and increased stay and play behaviors. For the other group, results indicate a functional relation between SPT with modified arrangement and increased stay and play behaviors. Future research is needed to determine effectiveness of SPT interventions for children with disabilities who have more sophisticated functional play skills, as well as utility of creating peer dyads compared with peer triads.

The effectiveness of supplemental phonics instruction employing constant time delay instruction for struggling readers

AbstractThis study examined the provision of supplemental instruction using constant time delay for struggling readers who had fallen behind in developing word‐blending skills. Additionally, the study examined the utility of adding a material reward contingency to the instructional program with a contingency derived from percentile‐shaping procedures. Procedures were compared in a withdrawal design applied across blocks of letters with word blending as the target response. Participants exhibited substantial learning gains when provided constant time delay instruction in phonics skills as compared to baseline demonstrating clear experimental control. Results for the constant time delay plus reward contingency conditions were clearly differentiated from baseline but undifferentiated from the other instructional conditions. The implications of the findings for intervention for struggling readers and future research relevant to more comprehensive reading interventions are discussed.

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents. Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported. This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol. RBR-6XTS8Z.

Paraprofessional support and perceptions of a function-based classroom intervention

ABSTRACTParaprofessionals carry out behavior interventions for students with challenging behavior in inclusive classroom settings. Examination of paraprofessional involvement in behavior interventions informs how paraprofessionals may best support intervention implementation. The researchers used a withdrawal design to evaluate the effects of a multiple-component intervention primarily conducted by paraprofessionals in decreasing one sixth-grade student's disruptive behavior. They then used a systematic approach to functional behavior assessment to identify the function of the student's behavior and to design an intervention, which was tested using a single-subject design. Results demonstrated a functional relation between the student's disruptive behavior and intervention. Further, the paraprofessionals and classroom teacher regarded the intervention as favorable, suggesting the intervention was feasible and suitable for the student. Discussion includes implications for practice and future research.

Empowering Teachers With Low-Intensity Strategies to Support Instruction: Within-Activity Choices in Third-Grade Math With Null Effects

Instructional choice is a low-intensity strategy that can improve academic engagement. In this study, we investigated the effects of within-activity choices offered during math by third-grade teachers to participating students with behavioral and academic needs. We utilized a professional development model to train teachers to implement instructional choice in the classroom while collecting direct observation data on student’s academic engagement. Teachers were able to implement practices with high levels of integrity and collect momentary time sampling data on one student with high levels of reliability. Using a withdrawal design, we found no clear functional relation between instructional choice and increases in student’s academic engagement. However, some students demonstrated an increase in level upon the introduction of the intervention. Both teachers and students rated the intervention goals, procedures, and outcomes as acceptable. Possible reasons for a lack of treatment effect on student academic engagement are discussed.

Serious Game for Children with Autism to Learn Vocabulary: An Experimental Evaluation

ABSTRACTThe use of serious games (SGs) to provide intervention for various skills to children with autism spectrum disorder (ASD) has increased in the recent years. However, the potential of these games has not been utilized to provide learning of vocabulary to children with ASD. In designing games for children with ASD, there is a need to consider components specifically from the perspectives of ASD and the generic components that can support from the theoretical, content, and game design aspects. In the absence of any existing framework to design games for children with ASD, this article first introduces a framework named serious game design framework (SGDF), constructed to provide support throughout the design process. This framework was constructed based on the extensive review of the literature on ASD and existing SGDFs. The article then focuses on the design and development of a SG prototype based on SGDF. An experimental evaluation prototype was conducted to examine the effectiveness using the withdrawal design of single-subject research design (SSRD) in improving the receptive identification of vocabulary items among children with autism before and after using the prototype. The receptive identification of vocabulary items is measured in terms of the number of correct responses given and the number of attempts made to identify the correct response. The pre- and post-evaluations of the SG prototype show that learning of vocabulary items among children with ASD improved after using the game and they retained items at the end of weeks 1 and 2 following the withdrawal of intervention.

A Classroom-Based Physical Activity Intervention for Elementary Student On-Task Behavior

ABSTRACTFew youths engage in the recommended amount of physical activity (PA). Many educators have concerns about increasing PA in schools, including taking time from academics, though studies show that school-based PA can be beneficial to academics. This study extends previous research on the relationship between school-based PA and time on task (TOT) by engaging students in teacher-led PA breaks in the classroom and observing students' on-task behavior for a longer period than previous studies. A third-grade class of 23 students from a rural New England public school was observed as part of a single-subject withdrawal design study. The class, therefore, served as its own control. Student on-task behavior was observed for 45 min following both inactive and active conditions using systematic direct observation procedures. The intervention consisted of 10 min of whole-body movement: 1–2 min of warm-ups, 6–8 min of moderate PA, and 1–2 min of cool-downs. Multiple measures of effect indicate that simple, 10-min, breaks for PA can improve TOT rates among elementary students. This study supports the use of brief breaks for PA to improve student TOT while also indicating that the effects persist for at least 45 min. This is valuable to educators who wish to increase TOT with a simple classroom intervention and for those who wish to help students meet the recommended amount of daily PA.

Behavior Bingo: The effects of a culturally relevant group contingency intervention for students with EBD

AbstractStudents with emotional and behavioral disorders (EBD) have difficulty with academic engagement during independent seatwork tasks. The goal of the current study was to evaluate the effectiveness of Behavior Bingo, a novel interdependent group contingency intervention, on the academic engagement, off‐task, and disruptive behavior of students with EBD during independent seatwork in an urban alternative high school setting. During the intervention, the class collaborated to fill in a posted Bingo board contingent on demonstrating appropriate behavior. Using an ABAB withdrawal design in two classrooms, the Behavior Bingo intervention showed promise as a feasible and effective classroom management intervention. Given the urban setting and diverse sample of participants, implications for culturally relevant and responsive intervention are discussed, including the role of peers in culturally responsive intervention, the use of randomization and uncertainty, preference assessment, and engaging intervention components.

Internet Gaming Disorder Treatment: A Case Study Evaluation of Four Different Types of Adolescent Problematic Gamers

Research examining Internet Gaming Disorder (IGD) has grown markedly in recent years. However, research on its psychological treatment is still scarce, especially with respect to efficacy of specific programs. The PIPATIC (Programa Individualizado Psicoterapéutico para la Adicción a las Tecnologías de la Información y la Comunicación) program is a 22-session specialized treatment for adolescents with IGD. The present paper briefly outlines the cases of four treatment-seeking male adolescents aged between 13 and 18 years with different clinical IGD profiles undergoing the treatment. A case study using an A-B-A’ withdrawal design was conducted. After completing the PIPATIC program, all participants showed clinical improvement in the amount of time spent using video games and in the symptoms of IGD. Results also demonstrated they received lower scores on clinical tests related to comorbid disorders. In an area with so few studies relating to IGD treatment, the present study is of existential value and contributes clinical information concerning the treatment of IGD in treatment-seeking adolescent patients.

The use of bicycle workstations to increase physical activity in secondary classrooms

<b>Background</b><br /> To date, the majority of interventions have implemented classroom-based physical activity (PA) at the elementary level; however, there is both the potential and need to explore student outcomes at high-school level as well, given that very few studies have incorporated classroom-based PA interventions for adolescents. One exception has been the use of bicycle workstations within secondary classrooms. Using bicycle workstations in lieu of traditional chairs in a high school setting shows promise for enhancing adolescents’ physical activity during the school day. <br /> <br /> <b>Participants and procedure</b><br /> The present study explored the effects of integrating bicycle workstations into a secondary classroom setting for four months in a sample of 115 adolescents using an A-B-A-B withdrawal design. The study took place in one Advanced Placement English classroom across five groups of students. Physical activity outcomes included average heart rate, and caloric expenditure. Behavioural outcomes included percentage of on-task/off-task behaviour and number of teacher prompts in redirecting off-task behaviour. Feasibility and acceptability data of using the bicycle workstations were also collected.<br /> <br /> <b>Results</b><br /> Findings showed significant improvements in physical activity as measured by heart rate and caloric expenditure, although heart rate percentage remained in the low intensity range when students were on the bicycle workstations. No effects were found on students’ on-task behaviour when using the bicycle workstations. Overall, students found the bikes acceptable to use but noted disadvantages of them as well.<br /> <br /> <b>Conclusions</b><br /> Using bicycle workstations in high-school settings appears promising for enhancing low-intensity physical activity among adolescents. The limitations of the present study and implications for physical activity interventions in secondary schools are discussed.

Using Visual Activity Schedules for Young Children With Challenging Behavior

Young children with challenging behavior may require individualized interventions to facilitate improved outcomes. Visual activity schedules (VAS) have been well documented for improving engagement, transition, and recreation behaviors with children with autism spectrum disorder (ASD) and intellectual disabilities (ID). However, children exhibiting challenging behavior in inclusive preschool settings do not necessarily have an ASD or ID diagnosis. This study evaluated the use of constant time delay (CTD) to teach three children without ASD or ID to use VAS. Engagement and challenging behavior were measured in the context of A-B-A-B withdrawal designs. Children learned to use the VAS and levels of engagement and challenging behavior matched levels similar to typical peers. However, children did not generalize schedule use to novel contexts. Results suggested that CTD+VAS may be a feasible individualized intervention to increase engagement in young children with challenging behavior who do not have ASD or ID.

Oral Aripiprazole as Maintenance Treatment in Adolescent Schizophrenia: Results From a 52-Week, Randomized, Placebo-Controlled Withdrawal Study

To evaluate the efficacy, safety, and tolerability of aripiprazole, a dopamine D2 receptor partial agonist, as maintenance treatment in adolescent outpatients with schizophrenia. This was a multicenter, double-blind, placebo-controlled, randomized withdrawal design trial. Participants 13 to 17 years of age with a diagnosis of schizophrenia (DSM-IV-TR) were first cross-titrated from their other oral antipsychotic(s) (4-6 weeks), then stabilized (7-21 weeks) on oral aripiprazole 10 to 30 mg/d, and finally randomized 2:1 to continuation of oral aripiprazole or to placebo in a double-blind maintenance phase (≤52 weeks). The primary endpoint was time from randomization to exacerbation of psychotic symptoms/impending relapse. Safety and tolerability were assessed. Of 201 enrolled participants, 146 were randomized to aripiprazole (n= 98) or placebo (n= 48) in the double-blind maintenance phase. Treatment with aripiprazole was associated with a significantly longer time to exacerbation of psychotic symptoms/impending relapse compared with placebo (hazard ratio, 0.46 [95% CI= 0.24-0.88]; p= .016). Aripiprazole was associated with lower rates of serious treatment-emergent adverse events (TEAEs) versus placebo (3.1% versus 12.5%; p= .059) and severe TEAEs (2.0% versus 10.4%; p= .039). The rate of discontinuation due to TEAEs was lower with aripiprazole versus placebo (20.4% versus 39.6%, p= .014; number-needed-to-harm= 5.1). The incidences of extrapyramidal symptoms, weight gain, and somnolence were similar or lower with aripiprazole than with placebo, and no TEAEs related to elevated serum prolactin were reported. Based on Tanner staging, 27.6% of participants treated with aripiprazole and 16.7% of those who received placebo progressed one or two stages from baseline. Aripiprazole was observed to be safe and effective for the maintenance treatment of adolescents with schizophrenia. Efficacy and Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia; http://clinicaltrials.gov/; NCT01149655.

AN ANALYTIC METHOD TO ADDRESS THE NON-LINEARITY FORM OF ALZHEIMER’S DISEASE MODIFYING MODEL

Statistical methods to address disease-modifying (DM) clinical data for agents like BACE for Alzheimer's disease require either randomized start or withdrawal designs. For ethical reasons randomized start design for AD are gaining more interest in the research communities and by regulatory agencies. Statistical methods to address disease modifying clinical trials are not fully developed yet. Statistical methods proposed for DM include work by C, Xiong and colleagues. These researchers proposed a trivariate distribution whose means and covariance matrix exist. The DM efficacy hypothesis is tested by comparing the rate of change of an efficacy outcome measures (e.g. ADAS-Cog) between treatment arms with and without a treatment switch. In their method, they considered the simplest longitudinal design of DM trials with 3 observations per subject and assumed a linear growth or decline pattern for the time 1 to 2 and 2 to 3 in the tested groups. Misspecification of the underlying models poses a danger in the conclusions of these trials. We plan extending this simple assumption to non-linear models and to investigate the effect of dropouts for long term trials of about 2 years or longer through simulations. Simulation results will be presented at the meeting.

USING IPADS TO PROMOTE PATIENT SAFETY AND REDUCE STAFF INJURIES IN DEMENTIA CARE

Background: The changes associated with dementia can lead to mood alterations and behavioral and psychological symptoms of dementia (BPSD). BPSD are common, affecting up to 90% of persons with dementia over the course of their illness. Not only do BPSD cause distress for the patients with dementia, but also place hospital staff at risk for injury.This project examines whether using an iPad to play a video purposively created for the patient by his or her family may contribute to preventing and reducing BPSD of patients with dementia. Methods: We used a single case study design and mixed methods. With an ABAB withdrawal design, a patient was observed in four phases, A1 (baseline, no intervention), B1 (intervention), A2 (withdrawal, no intervention) and B2 (intervention again). Also, we conducted staff interviews and video analysis to investigate contextual factors and staff experiences. Results: Our preliminary findings support positive effects of the intervention. Staff described the benefits and barriers of integrating iPad into everyday care activities on the hospital unit. Conclusions: This research contributes to the knowledge base of using technology (iPad) as a non-pharmacological intervention in dementia care. The iPad has great potential to be a safe, easy and low cost solution for supporting patient safety and reduction of staff injuries in clinical settings.

Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies.

Opioids are critical for managing cancer pain, but may provide inadequate relief and/or unacceptable side effects in some cases. To assess the analgesic efficacy of adjunctive Sativex (Δ9-tetrahydrocannabinol (27 mg/mL): cannabidiol (25 mg/mL)) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design). The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65 years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00-17.95; p = 0.040) that was not observed in patients <65 years from the rest of the world (median treatment difference: 0.2; 95% CI: -5.00 to 7.74; p = 0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified. Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.

EFFECTS OF TOOTLING ON CLASSWIDE DISRUPTIVE AND ACADEMICALLY ENGAGED BEHAVIOR OF GENERAL‐EDUCATION HIGH SCHOOL STUDENTS

Considered the opposite of tattling, Tootling is a positive peer‐reporting procedure in which students report their classmates’ positive prosocial behavior instead of inappropriate behavior and employs other well‐established behavior analytic principles. This study examined the effects of Tootling on students’ behavior in three general‐education high school classrooms. Students wrote and then submitted tootles into a marked container. Teachers recorded the number of tootles on publicly posted progress charts, and read a sample of tootles at the end of the class period. An interdependent group contingency procedure was used along with a class goal of the number of tootles needed to earn the class a reward. An A‐B‐A‐B withdrawal design with follow‐up found decreases in classwide disruptive behavior and increases in academically engaged behavior across classrooms. Results suggest that Tootling can provide high school teachers a method for positively reinforcing students’ prosocial behavior, and function as a preventative measure against disruptive behavior. Issues related to social validity and directions for future research are discussed.