scholarly journals Using a Sequential Multiple Assignment Randomized Trial (SMART) to Develop an Adaptive K–2 Literacy Intervention With Personalized Print Texts and App-Based Digital Activities

AERA Open ◽  
2019 ◽  
Vol 5 (3) ◽  
pp. 233285841987270 ◽  
Author(s):  
James S. Kim ◽  
Catherine A. Asher ◽  
Mary Burkhauser ◽  
Laura Mesite ◽  
Diana Leyva
Keyword(s):  
Reading Comprehension ◽  
Randomized Trial ◽  
Text Messages ◽  
Literacy Intervention ◽  
Digital Content ◽  
Adaptive Intervention ◽  
Multiple Assignment ◽  
Stage 1 ◽  
To Receive

This study employs a sequential multiple assignment randomized trial (SMART) design to develop an adaptive intervention with personalized print and digital content for kindergarten to Grade 2 children (n = 273). In Stage 1, we ask whether it is better for children to receive an adaptive intervention based on (a) 10 conceptually coherent texts or (b) 10 leveled texts on a range of topics. In Stage 2, we ask how best to encourage nonresponding children. Findings indicate that children who received either conceptually coherent texts or leveled texts performed similarly on reading comprehension posttests, while augmenting and intensifying follow-up with gamification of the app and text messages to parents improved comprehension outcomes for nonresponders. Descriptively, we find that only 26% (n = 71) of parents accessed the app, highlighting the need for better implementation procedures to increase take up of app-based digital activities.

A Pilot Study of Mobile Telephone Message Interventions with Suicide Attempters in China

Crisis ◽  
2010 ◽  
Vol 31 (2) ◽  
pp. 109-112 ◽  
Author(s):  
Hui Chen ◽  
Brian L. Mishara ◽  
Xiao Xian Liu
Keyword(s):  
Pilot Study ◽  
Effective Means ◽  
Text Message ◽  
Text Messages ◽  
Mobile Telephone ◽  
Future Research ◽  
Quick Method ◽  
Suicide Attempters ◽  
To Receive

Background: In China, where follow-up with hospitalized attempters is generally lacking, there is a great need for inexpensive and effective means of maintaining contact and decreasing recidivism. Aims: Our objective was to test whether mobile telephone message contacts after discharge would be feasible and acceptable to suicide attempters in China. Methods: Fifteen participants were recruited from suicide attempters seen in the Emergency Department in Wuhan, China, to participate in a pilot study to receive mobile telephone messages after discharge. All participants have access to a mobile telephone, and there is no charge for the user to receive text messages. Results: Most participants (12) considered the text message contacts an acceptable and useful form of help and would like to continue to receive them for a longer period of time. Conclusions: This suggests that, as a low-cost and quick method of intervention in areas where more intensive follow-up is not practical or available, telephone messages contacts are accessible, feasible, and acceptable to suicide attempters. We hope that this will inspire future research on regular and long-term message interventions to prevent recidivism in suicide attempters.

scholarly journals A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bradley S. Peterson ◽  
Amy E. West ◽  
John R. Weisz ◽  
Wendy J. Mack ◽  
Michele D. Kipke ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Anxiety Disorders ◽  
Randomized Trial ◽  
The Other ◽  
Smart Study ◽  
Main Effect ◽  
Multiple Assignment ◽  
Stage 1 ◽  
Main Effects ◽  
Treatment Sequences

Abstract Background Treatment of a child who has an anxiety disorder usually begins with the question of which treatment to start first, medication or psychotherapy. Both have strong empirical support, but few studies have compared their effectiveness head-to-head, and none has investigated what to do if the treatment tried first isn’t working well—whether to optimize the treatment already begun or to add the other treatment. Methods This is a single-blind Sequential Multiple Assignment Randomized Trial (SMART) of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children will be randomized to fluoxetine or Coping Cat Cognitive Behavioral Therapy (CBT). In Stage 2, remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1. Non-remitters during the first 12 weeks of treatment will be randomized to either [1] optimization of their Stage 1 treatment, or [2] optimization of Stage 1 treatment and addition of the other intervention. After the 24-week trial, we will follow participants during open, naturalistic treatment to assess the durability of study treatment effects. Patients, 8–17 years of age who are diagnosed with an anxiety disorder, will be recruited and treated within 9 large clinical sites throughout greater Los Angeles. They will be predominantly underserved, ethnic minorities. The primary outcome measure will be the self-report score on the 41-item youth SCARED (Screen for Child Anxiety Related Disorders). An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first (“Main Effect 1”). Then, among Stage 1 non-remitters, we will compare non-remitters randomized to optimization of their Stage 1 monotherapy versus non-remitters randomized to combination treatment (“Main Effect 2”). The interaction of these main effects will assess whether one of the 4 treatment sequences (CBT➔CBT; CBT➔med; med➔med; med➔CBT) in non-remitters is significantly better or worse than predicted from main effects alone. Discussion Findings from this SMART study will identify treatment sequences that optimize outcomes in ethnically diverse pediatric patients from underserved low- and middle-income households who have anxiety disorders. Trial registration This protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275.

scholarly journals Outcomes of decentralizing hypertension care from district hospitals to health centers in Rwanda, 2013–2014

2019 ◽  
Vol 9 (4) ◽  
pp. 142-147
Author(s):  
G. Ngoga ◽  
P. H. Park ◽  
R. Borg ◽  
G. Bukhman ◽  
E. Ali ◽  
...  
Keyword(s):  
Communicable Disease ◽  
Health Centers ◽  
Blood Pressure Targets ◽  
District Hospitals ◽  
Significant Difference ◽  
Stage 1 ◽  
To Receive ◽  
Non Communicable Disease

Setting: Three district hospitals (DHs) and seven health centers (HCs) in rural Rwanda.Objective: To describe follow-up and treatment outcomes in stage 1 and 2 hypertension patients receiving care at HCs closer to home in comparison to patients receiving care at DHs further from home.Design: A retrospective descriptive cohort study using routinely collected data involving adult patients aged 18 years in care at chronic non-communicable disease clinics and receiving treatment for hypertension at DH and HC between 1 January 2013 and 30 June 2014.Results: Of 162 patients included in the analysis, 36.4% were from HCs. Patients at DHs travelled significantly further to receive care (10.4 km vs. 2.9 km for HCs, P < 0.01). Odds of being retained were significantly lower among DH patients when not adjusting for distance (OR 0.11, P = 0.01). The retention effect was consistent but no longer significant when adjusting for distance (OR 0.18, P = 0.10). For those retained, there was no significant difference in achieving blood pressure targets between the DHs and HCs.Conclusion: By removing the distance barrier, decentralizing hypertension management to HCs may improve long-term patient retention and could provide similar hypertension outcomes as DHs.

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences

2021 ◽  
Author(s):  
Nancy E Sherwood ◽  
A Lauren Crain ◽  
Elisabeth M Seburg ◽  
Meghan L Butryn ◽  
Evan M Forman ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Response Assessment ◽  
Optimal Time ◽  
Behavioral Weight Loss ◽  
Weight Loss Treatment ◽  
Adaptive Intervention ◽  
Weight Losses ◽  
Multiple Assignment

Abstract Background State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30–60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit. Purpose Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT). Method The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months. Results PCM participants lost more weight at 6 months (−18.4 lbs, 95% CI −20.5, −16.2) than ABT participants (−15.7 lbs, 95% CI: −18.0, −13.4), but this difference was not statistically significant (−2.7 lbs, 95% CI: −5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03). Conclusions Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work. Clinical Trial information ClinicalTrials.gov identifier; NCT02368002

Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2b

1999 ◽  
Vol 17 (3) ◽  
pp. 968-968 ◽  
Author(s):  
Steven A. Rosenberg ◽  
James C. Yang ◽  
Douglas J. Schwartzentruber ◽  
Patrick Hwu ◽  
Francesco M. Marincola ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Metastatic Melanoma ◽  
Interleukin 2 ◽  
Interferon Alfa ◽  
Prospective Randomized Trial ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
Randomized Protocols ◽  
To Receive

PURPOSE: The combination of chemotherapy with immunotherapeutic agents such as interleukin-2 and interferon alfa-2b has been reported to provide improved treatment results in patients with metastatic melanoma, compared with the use of chemotherapy alone. We have performed a prospective randomized trial in patients with metastatic melanoma, comparing treatment with chemotherapy to treatment with chemoimmunotherapy. PATIENTS AND METHODS: One hundred two patients with metastatic melanoma were prospectively randomized to receive chemotherapy composed of tamoxifen, cisplatin, and dacarbazine or this same chemotherapy followed by interferon alfa-2b and interleukin-2. Objective responses, survival, and toxicity in the two groups were evaluated at a median potential follow-up of 42 months. RESULTS: In 52 patients randomized to receive chemotherapy, there were 14 objective responses (27%), including four complete responses. In 50 patients randomized to receive chemoimmunotherapy, there were 22 objective responses (44%) (P2 = .071), including three complete responses. In both treatment groups, the duration of partial responses was often short, and there was a trend toward a survival advantage for patients receiving chemotherapy alone (P2 = .052; median survival of 15.8 months compared with 10.7 months). Treatment-related toxicities were greater in patients receiving chemoimmunotherapy. CONCLUSION: With the treatment regimens used in this study, the addition of immunotherapy to combination chemotherapy increased toxicity but did not increase survival. The use of combination chemoimmunotherapy regimens is not recommended in the absence of well-designed, prospective, randomized protocols showing the benefit of this treatment strategy.

scholarly journals Final Results of the IELSG-19 Randomized Trial of Mucosa-Associated Lymphoid Tissue Lymphoma: Improved Event-Free and Progression-Free Survival With Rituximab Plus Chlorambucil Versus Either Chlorambucil or Rituximab Monotherapy

2017 ◽  
Vol 35 (17) ◽  
pp. 1905-1912 ◽  
Author(s):  
Emanuele Zucca ◽  
Annarita Conconi ◽  
Giovanni Martinelli ◽  
Reda Bouabdallah ◽  
Alessandra Tucci ◽  
...  
Keyword(s):  
Overall Survival ◽  
Randomized Trial ◽  
Lymphoid Tissue ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Free Survival ◽  
Final Sample ◽  
Phase Iii Study ◽  
To Receive

Purpose There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m2/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m2 intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.

International neuroblastoma staging system stage 1 neuroblastoma: a prospective study and literature review.

1996 ◽  
Vol 14 (7) ◽  
pp. 2174-2180 ◽  
Author(s):  
B H Kushner ◽  
N K Cheung ◽  
M P LaQuaglia ◽  
P F Ambros ◽  
I M Ambros ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Staging System ◽  
Cytotoxic Therapy ◽  
Staging Systems ◽  
International Neuroblastoma Staging System ◽  
A Prospective Study ◽  
Stage 1 ◽  
To Receive ◽  
Insight Into

PURPOSE To gain insight into the management of non-metastatic neuroblastoma by examining clinical and biologic features of International Neuroblastoma Staging System (INSS) stage 1 tumors. METHODS Patients were staged by both the INSS and the Evans staging system and were evaluated for biologic prognostic factors. Patients with INSS stage 1 received no cytotoxic therapy. The literature was reviewed for clinical and biologic data about INSS stage 1. RESULTS We evaluated 10 consecutive patients (median age, 17.5 months) with INSS stage 1; all remain disease-free (median follow-up duration, > 5 years). Tumors were in the abdomen (n = 6), chest (n = 3), or pelvis (n = 1). Neuroblastoma involved margins of resection in six tumors. Poor-prognostic biologic findings included tumor-cell diploidy (n = 2) and unfavorable Shimada histopathology (n = 2). Two patients were to receive chemotherapy for, respectively, a tumor deemed unresectable and a tumor classified as Evans stage III; second opinions resulted in surgical management alone in each case. Published reports confirm that some INSS stage 1 patients (1) are at risk for overtreatment, and (2) have poor-prognostic biologic findings yet do well. CONCLUSION Surgery alone suffices for INSS stage 1 neuroblastoma, even if biologic prognostic factors are unfavorable, microscopic disease remains after surgery, and tumor size is suggestive of "advanced-stage" status in other staging systems. Attempts to resect regionally confined neuroblastomas should take precedence over immediate use of cytotoxic therapy; otherwise, some patients may receive chemotherapy or radiotherapy unnecessarily.

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