Evidence map›Paper›PMID 34193105›Full record

Trial reportBMC psychiatry2021

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

Bradley S Peterson, Amy E West, John R Weisz, Wendy J Mack, Michele D Kipke, Robert L Findling, Brian S Mittman, Ravi Bansal, Steven Piantadosi, Glenn Takata and 11 more

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

Trial report in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04760275 (A Sequential Multiple Assignment Randomized Trial), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 26% 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.

NCT04760275 phase3active not recruitingnot on this map

A Sequential Multiple Assignment Randomized Trial (SMART) Assessing Medication and CBT Sequencing Strategies in the Treatment of Predominantly Ethnic Minority, Underserved Youth With Anxiety Disorders

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2021 to 2026Enrolled316ConditionsAnxiety DisordersArmsFluoxetine, Cognitive Behavioral Therapy (CBT)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. 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

21 authors at 9 institutions in 1 country.

Bradley S PetersonChildren's Hospital Los Angeles, Los Angeles, CA, USA. bpeterson@chla.usc.edu.ORCID 0000-0001-5737-225X
Amy E WestChildren's Hospital Los Angeles, Los Angeles, CA, USA.
John R WeiszDepartment of Psychology, Harvard University, Cambridge, USA.
Wendy J MackDepartment of Preventive Medicine, Keck School of Medicine at The University of Southern California, Los Angeles, USA.
Michele D KipkeChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Robert L FindlingVirginia Commonwealth University, Richmond, USA.
Brian S MittmanDepartment of Research & Evaluation, Kaiser Permanente, Los Angeles, USA.
Ravi BansalChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Steven PiantadosiBrigham And Women's Hospital, Harvard Medical School, Boston, USA.
Glenn TakataChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Corinna KoebnickDepartment of Research & Evaluation, Kaiser Permanente, Los Angeles, USA.
Ceth AshenChildren's Bureau of Southern California, Los Angeles, USA.
Christopher SnowdyDepartment of Psychiatry, Keck School of Medicine at The University of Southern California, Los Angeles, USA.
Marie PoulsenChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Bhavana Kumar AroraChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Courtney M AllemChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Marisa PerezHathaway-Sycamores Child and Family Services, Altadena, USA.
Stephanie N MarcyChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Bradley O HudsonChildren's Hospital Los Angeles, Los Angeles, CA, USA.
Stephanie H ChanLifeStance Health California, Encinitas, USA.
Robin WeersingSDSU-UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego State University, San Diego, USA.
University of Southern California · USChildren's Hospital of Los Angeles · USKaiser Permanente · USBrigham and Women's Hospital · USChild & Family Service · USFreedom to Live · USHarvard University · USSan Diego State University · USVirginia Commonwealth University · US

Funding

Patient-Centered Outcomes Research Institute PEDS-2019C1-16008
6 · The paper itself

Abstract

backgroundTreatment 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.

methodsThis 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 registrationThis protocol, version 1.0, was registered in ClinicalTrials.gov on February 17, 2021 with Identifier: NCT04760275 .

Indexed as

Cognitive Behavioral TherapyAdolescentAnimalsAnxiety DisordersCatsChildFluoxetineHumansPsychotherapySingle-Blind MethodTreatment OutcomeFluoxetine

Identifiers

PMID34193105
PMCPMC8243307
OpenAlexW3173794038

What OpenQuestion holds

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LicenceCC BY
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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.