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Search / Trial NCT06942429

Stepped Versus Stratified Care for Anxiety Disorders in Youth

Launched by REGION SKANE · Apr 16, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Anxiety Disorders Children Adolescents Cognitive Behavioral Therapy Non Inferiority Care Models Stepped Care Stratified Care

ClinConnect Summary

This clinical trial is studying two different approaches to help children and teenagers aged 8 to 17 who are dealing with anxiety disorders, such as social anxiety, panic disorder, and generalized anxiety. The researchers want to find out if a "stepped care" approach, where everyone starts with an online therapy course followed by in-person sessions if needed, is just as effective as a "stratified care" approach, where participants receive a type of therapy based on how complicated their situation is.

To be eligible for the trial, children must be between 8 and 17 years old, have a confirmed anxiety disorder, and have a caregiver who can support them during treatment. Participants will be randomly assigned to one of the two care models and will take part in assessments throughout the treatment and up to two years after. They might receive online therapy, in-person therapy, or both, depending on how they respond to the treatment. This trial is not yet recruiting, but it aims to help understand which care model might work better for young people struggling with anxiety.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
  • 2. Principal DSM-5-TR anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia. Confirmed by the structured diagnostic interview (DIAMOND-KID). "Principal" indicates that the anxiety disorder is judged by the clinician to be in most urgent need of treatment (among potential co-occurring disorders).
  • 3. Available caregiver who can support the child in treatment. Confirmed by the caregiver.
  • 4. Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
  • 5. Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
  • 6. Access to the internet. Confirmed by the child and/or caregiver.
  • 7. Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver.
  • Exclusion Criteria:
  • 1. Principal DSM-5-TR anxiety disorder of specific phobia concerning the domain of blood-injection-injury (due to the ICBT program not including relevant information on applied-tension techniques to avoid fainting during exposure exercises). Confirmed by a specific phobia of this sort being classified as the most functionally impairing anxiety disorder during the structured diagnostic interview (DIAMOND-KID).
  • 2. Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
  • 3. Social/familial/educational difficulties in more immediate need of management than an anxiety disorder. Confirmed by the assessor through information from the child and/or caregiver and/or other available sources.
  • 4. Immediate risk to self or others that require urgent attention, such as suicidality. Confirmed by the assessor through information from the child and/or caregiver and other available sources.
  • 5. The potential participant has a relative (e.g., sibling, cousin) included in the study. Confirmed by the assessor through information from the caregiver and other available sources.

About Region Skane

Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.

Locations

Lund, , Sweden

Patients applied

0 patients applied

Trial Officials

Matti Cervin, PhD

Principal Investigator

Lund University & CAMHS Skåne

Eva Serlachius, MD, PhD

Principal Investigator

Lund University & CAMHS Skåne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported