Stepped Versus Stratified Care for Anxiety Disorders in Youth (NCT06942429) | Clinical Trial Compass
RecruitingNot Applicable
Stepped Versus Stratified Care for Anxiety Disorders in Youth
Sweden556 participantsStarted 2025-06-19
Plain-language summary
The goal of this clinical trial is to compare stepped care to stratified care as overall healthcare models for children and adolescents aged 8-17 with anxiety disorders. It addresses one main question:
• Is stepped care non-inferior to stratified care in supporting participants to achieve a treatment response?
Researchers will compare two care models:
* Stepped care, where all participants begin with 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) and receive an additional 14 weeks of personalized in-person CBT if needed.
* Stratified care, where participants are assigned to either 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, and may also receive additional 14 weeks of in-person CBT if necessary.
Participants will:
* Be randomly assigned to one of the two care models.
* Complete a wide range of assessments at baseline, during treatment, and at 4, 8, 12, and 24 months, with the 8-month point as the primary endpoint.
* Receive either ICBT, in-person CBT, or both, depending on their care model and response to treatment.
* Participate in ancillary studies involving DNA sampling, cognitive testing, and national registry linkages to help predict treatment response and long-term outcomes.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion criteria
✓. Aged 8.0 to 17.5 years. Confirmed by the child and/or caregiver.
✓. 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).
✓. Available caregiver who can support the child in treatment. Confirmed by the caregiver.
✓. Child and at least one caregiver can read, write, and communicate in Swedish. Confirmed by the child and/or caregiver.
✓. Child (≥13 years) and caregiver have access to a Swedish electronic identification (BankID or Freja eID).
✓. Access to the internet. Confirmed by the child and/or caregiver.
✓. Ability to attend in-person CBT sessions at the clinic. Confirmed by the child and/or caregiver.
. 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).
✕. Ongoing psychological treatment for an anxiety disorder. Confirmed by the child and/or caregiver.
✕. 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.
✕. 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.
✕. 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.