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

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 .

Need for and Steps Toward a Clinical Guideline for the Telemental Healthcare of Children and Adolescents.

OBJECTIVE: This article identifies and describes key considerations toward the development of a clinical guideline intended to optimize telemental healthcare (TMH) of children and adolescents. METHODS: The literature was searched with key terms and title words. Of 2824 articles that met primary or secondary key word search criteria, 326 met both criteria, and 118 thematically related directly to child and adolescent TMH. Only 44 studies met levels of evidence I-III and expert recommendation criteria used in clinical guidelines; review of their references found 8 additional studies (52 total). Data from adult, child, and adolescent in-person psychiatric care and adult TMH were applied to provide context in developing the key considerations. RESULTS: TMH guidelines for adults are well delineated, and TMH guidelines for children and adolescents are likely to closely overlap in terms of general clinical, technical, and administrative issues. However, for a child and adolescent focus, modifications of existing general guidelines appear necessary; for example, based on developmental status, family involvement, and patient-site modifications for space and sound. Additional clinical issues include specify who, exactly, is the "patient" (i.e., the patient, family, and /or other stakeholders), modalities of care (i.e., age-related psychotherapies such as play therapy or behavior management), and psychopharmacology. CONCLUSIONS: Specific clinical, administrative, and technical issues are key considerations - based on the nuances of established child and adolescent mental healthcare - and must be considered in developing a clinical guideline for TMH of these patients. Developing such guidance should proceed from a careful review of the growing evidence base, and through expert consensus processes.