Evidence map›Paper›PMID 37353795›Full record

ArticlePediatric rheumatology online journal2023

A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations.

Natoshia R Cunningham, Alaina Miller, Samantha L Ely, Mallet R Reid, Ashley Danguecan, Sarah I Mossad, Luana Flores Pereira, Khalid Abulaban, Elizabeth Kessler, Natalie Rosenwasser and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric rheumatology online journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04335643 (A Remotely Delivered CBT Intervention for Youth With cSLE), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04335643 nacompletednot on this map

A Remotely Delivered CBT Intervention for Youth With cSLE: A Multi-site Patient-engaged Investigation

TypeinterventionalSponsorMichigan State UniversityRan2020 to 2024Enrolled65ConditionsSystemic Lupus ErythematosusArmsTEACH
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 2 countries.

Natoshia R CunninghamDepartment of Family Medicine, Michigan State University, 15 Michigan St NE, Grand Rapids, MI, 49503, US. Natoshia@msu.edu.ORCID http://orcid.org/0000-0002-1788-7264
Alaina MillerSchool of Professional Psychology, Wright State University, 3640 Colonel Glenn Hwy, Dayton, OH, 45435, US.
Samantha L ElyDepartment of Family Medicine, Michigan State University, 15 Michigan St NE, Grand Rapids, MI, 49503, US.
Mallet R ReidDepartment of Psychology, Michigan State University, 316 Physics Rd, East Lansing, MI, 48824, US.
Ashley DanguecanDepartment of Psychology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Sarah I MossadDepartment of Psychology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Luana Flores PereiraThe Hospital for Sick Children, Mental Health and Neurosciences Program, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Khalid AbulabanPediatric Rheumatology, Helen DeVos Children's Hospital, 35 Michigan St NE, Grand Rapids, MI, 49503, US.
Elizabeth KesslerPediatric Rheumatology, Helen DeVos Children's Hospital, 35 Michigan St NE, Grand Rapids, MI, 49503, US.
Natalie RosenwasserRheumatology, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA, 98105, US.
Kabita NandaRheumatology, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA, 98105, US.
Tamar RubinsteinDivision of Pediatric Rheumatology, Department of Pediatrics, Children's Hospital at Montefiore/Albert Einstein College of Medicine, 3415 Bainbridge Ave, NY, 10467, Bronx, US.
Mathew ReevesMichigan State University, Department of Epidemiology and Biostatistics, 909 Wilson Rd, MI, 48824, East Lansing, US.
Sara Ahola KohutChild Health Evaluative Sciences, The Hospital for Sick Children, 555 University Ave, ON, M5G 1X8, Toronto, Canada.
Jennifer StinsonChild Health Evaluative Sciences, The Hospital for Sick Children, 555 University Ave, ON, M5G 1X8, Toronto, Canada.
Tala El TalDivision of Rheumatology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Deborah M LevyDivision of Rheumatology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Linda HirakiDivision of Rheumatology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Emily A SmithermanUniversity of Alabama at Birmingham, The Children's Hospital CPP N G10, 1600 7 Ave S Birmingham, Birmingham, AL, 35223-1711, USA.
Andrea M KnightDivision of Rheumatology, The Hospital for Sick Children, 555 University Ave, Toronto, ON, M5G 1X8, Canada.
Hospital for Sick Children · CAMichigan State University · USHelen DeVos Children's Hospital · USSeattle Children's Hospital · USAlbert Einstein College of Medicine · USChildren's of Alabama · USWayne State University · USWright State University · US

Funding

Childhood Arthritis and Rheumatology Research Alliance Transdisciplinary Research Grant
6 · The paper itself

Abstract

backgroundChildhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described.

methodsThis two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol. Participants will be randomized to a six-week remotely delivered TEACH program plus medical treatment as usual (TAU) or TAU alone. We will include patients ages 12-22 years presenting to rheumatology clinics from six sites. Validated measures of fatigue, depressive symptoms, and pain will be obtained at baseline and approximately eight and 20 weeks later. Protocol adjustments were also made due to the COVID-19 pandemic, in collaboration with the investigative team, which included patients and caregivers.

conclusionsFindings from this multi-site RCT aim to document the feasibility of TEACH and provide an estimate of effect of a remotely delivered TEACH protocol on fatigue, depression, and pain symptoms in youth with cSLE as compared to standard medical treatment alone. This findings may positively impact clinical care for patients with cSLE. CLINICAL TRIALS: gov registration: NCT04335643.

Indexed as

COVID-19Lupus Erythematosus, SystemicAdolescentChildFatigueHumansMulticenter Studies as TopicPainPilot ProjectsRandomized Controlled Trials as TopicYoung AdultChildhood-onset systemic lupus erythematosus (cSLE)Cognitive behavioral therapyDepressive symptomsFatiguePainRCT- randomized clinical trial

Identifiers

PMID37353795
PMCPMC10290375
OpenAlexW4381839454

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.