A pilot randomized controlled trial of stepped vs stratified care for pediatric anxiety disorders (Dnr: 2022-07219-01)

Project: Research

Project Details


This research is supported by funding from L. J. Boëthius stiftelse (no grant number); Region Skåne (ALF; grant number: 2022-Projekt 0119), Region Skåne (internal research grant; no grant number), Stiftelsen Lindhaga (no grant number), The Crafoord Foundation (grant number: F2022/1648), The Swedish Society of Medicine (grant number: SLS-985932), and The Swedish Research Council for Health, Working Life and Welfare (Forte; grant number: 2022-00976).

Anxiety disorders are a major contributor to disability in children and adolescents. Cognitive behavioral therapy (CBT), delivered both in-person and by the internet (ICBT), is efficacious, but how to best organize the care pathway to increase access and benefit is unclear.

With the aim to conduct a fully powered randomized controlled trial, the present study is a randomized controlled, single-blind, pilot study where 50 youth with anxiety disorders and their caregivers will be randomized (1:1) to stepped care or stratified care. Stepped and stratified care are two competing service delivery models which include evidence-based interventions but differ regarding the timing and staging of interventions. In the stepped care arm, all participants will begin with 12 modules of ICBT delivered over 12 weeks. Participants with an insufficient response will then be offered 12-weeks of personalized in-person CBT. In the stratified care arm, we aim to offer about half of the participants ICBT and the other half in-person CBT, with this selection being based on a risk score algorithm that integrates known predictors of non-response to treatment. Mirroring the structure in stepped care, all non-responders in stratified care (both those who started with ICBT and in-person CBT) will be offered an additional 12-week course of in-person CBT. The ICBT and in-person CBT interventions will be identical in treatment length, but will differ in the delivery of treatment, utilizing the possibility of increased personalization and therapist-involvement in in-person CBT. The primary endpoint of the study will be the second outcome assessment conducted 30 to 33 weeks after randomization. The objectives of the pilot study are to examine feasibility, acceptability, and safety of study procedures, precision of the risk score algorithm, and statistical properties of outcome measures.
Effective start/end date2023/01/012027/05/31

Collaborative partners

UKÄ subject classification

  • Psychiatry
  • Psychology

Free keywords

  • Anxiety Disorders
  • Children and Adolescents
  • Randomized Controlled Trial
  • Stepped Care
  • Internet-delivered CBT