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

Autor: Peterson BS; Children's Hospital Los Angeles, Los Angeles, CA, USA. bpeterson@chla.usc.edu.; Department of Psychiatry, Keck School of Medicine at The University of Southern California, Los Angeles, USA. bpeterson@chla.usc.edu., West AE; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Weisz JR; Department of Psychology, Harvard University, Cambridge, USA., Mack WJ; Department of Preventive Medicine, Keck School of Medicine at The University of Southern California, Los Angeles, USA., Kipke MD; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA.; Department of Preventive Medicine, Keck School of Medicine at The University of Southern California, Los Angeles, USA., Findling RL; Virginia Commonwealth University, Richmond, USA., Mittman BS; Department of Research & Evaluation, Kaiser Permanente, Los Angeles, USA., Bansal R; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Piantadosi S; Brigham And Women's Hospital, Harvard Medical School, Boston, USA., Takata G; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Koebnick C; Department of Research & Evaluation, Kaiser Permanente, Los Angeles, USA., Ashen C; Children's Bureau of Southern California, Los Angeles, USA., Snowdy C; Department of Psychiatry, Keck School of Medicine at The University of Southern California, Los Angeles, USA., Poulsen M; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Arora BK; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Allem CM; Children's Hospital Los Angeles, Los Angeles, CA, USA., Perez M; Hathaway-Sycamores Child and Family Services, Altadena, USA., Marcy SN; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Hudson BO; Children's Hospital Los Angeles, Los Angeles, CA, USA.; Department of Pediatrics, Keck School of Medicine at the University of Southern California, Los Angeles, USA., Chan SH; LifeStance Health California, Encinitas, USA., Weersing R; SDSU-UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego State University, San Diego, USA.
Jazyk: angličtina
Zdroj: BMC psychiatry [BMC Psychiatry] 2021 Jun 30; Vol. 21 (1), pp. 323. Date of Electronic Publication: 2021 Jun 30.
DOI: 10.1186/s12888-021-03314-y
Abstrakt: 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 .
Databáze: MEDLINE
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