Stepped versus stratified care for anxiety in children and adolescents

Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial

This project tests whether starting all 8–17-year-olds with anxiety on online CBT and adding in-person CBT only if needed (stepped care) works as well as assigning online or in-person CBT up front based on clinical complexity (stratified care).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: Region Skane (Academic / other)
• Locations: 1 site (Lund)
• Trial ID: NCT06942429 on ClinicalTrials.gov

What this trial studies

Children and adolescents aged 8–17 with a principal DSM-5-TR anxiety disorder are randomized to two care models: stepped care or stratified care. In stepped care everyone receives 14 weeks of internet-delivered cognitive behavioral therapy (ICBT) with the option of 14 additional weeks of personalized in-person CBT if needed; in stratified care participants are assigned to 14 weeks of ICBT or 14 weeks of in-person CBT based on clinical complexity, with the same option for extra in-person CBT if necessary. Outcomes are measured at baseline, during treatment, and at 4, 8 (primary endpoint), 12, and 24 months using standardized clinical assessments. The trial is conducted in Lund, Sweden and requires caregiver involvement and Swedish-language participation.

Who should consider this trial

Good fit: Ideal candidates are Swedish-speaking children and adolescents aged 8 to 17.5 with a principal anxiety disorder, who have caregiver support, internet access, and the ability to attend in-person sessions if needed.

Not a fit: Patients who cannot read Swedish, lack caregiver support or internet access, cannot attend in-person clinic visits, or who require immediate intensive or specialized care may not benefit from these care models.

Why it matters

Potential benefit: If successful, this approach could increase access to effective therapy and reduce unnecessary in-person visits while maintaining good clinical outcomes.

How similar studies have performed: Internet-delivered CBT for youth anxiety has shown effectiveness in prior studies and stepped-care approaches have some supportive evidence, but direct randomized comparisons between stepped and stratified care are limited.

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.

Where this trial is running

Lund

• Forskningsmottagning Barn och ungdomspsykiatri Lund — Lund, Sweden (Recruiting)

Study contacts

• Principal investigator: Matti Cervin, PhD — Lund University & CAMHS Skåne
• Study coordinator: Matti Cervin, PhD

Conditions Social Anxiety Disorder; Separation Anxiety Disorder; Specific Phobia; Panic Disorder; Generalized Anxiety Disorder; Agoraphobia; anxiety disorders; children