RecruitingNot ApplicableNCT06942429

Stepped Versus Stratified Care for Anxiety Disorders in Youth

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


Sponsor

Region Skane

Enrollment

556 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two treatment approaches — stepped care (starting simple and increasing intensity if needed) versus stratified care (matching treatment intensity to symptom severity from the start) — for children and teenagers with anxiety disorders in Sweden. **You may be eligible if...** - Your child is aged 8 to 17.5 years - Your child has a primary diagnosis of social anxiety, generalised anxiety, panic disorder, separation anxiety, specific phobia, or agoraphobia - A caregiver is available to support your child through treatment - Your child and at least one caregiver can read, write, and communicate in Swedish - You have access to the internet and Swedish digital ID (BankID or Freja eID) - You are able to attend in-person therapy sessions if required **You may NOT be eligible if...** - Your child's main phobia is blood/injections/needles (a specific subtype not covered by the program) - Your child has a condition that requires more intensive treatment than the study provides Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALInternet-delivered cognitive-behavioral therapy

Internet-delivered cognitive behavioral therapy (ICBT) is a 12-module intervention delivered over a maximum of 14 weeks. Two age-specific versions are available: \[1\] for children aged 8-12 years and \[2\] for adolescents aged 13-17 years. Both versions share the same core content, but the texts, illustrations, videos, and exercises are adapted to be developmentally appropriate. Each version focuses on exposure, along with psychoeducation, coping strategies, and relapse prevention. Caregivers have access to a parallel program that mirrors the structure of the youth program. Both patients and caregivers engage with a therapist through a secure digital platform, communicating via text messages similar to emails. Two scheduled telephone or videoconference calls are conducted approximately 3-4 and 7-8 weeks into treatment, respectively, to follow up on adherence and address questions related to the intervention. Additional telephone support will be available on demand.

BEHAVIORALPersonalized in-person cognitive-behavioral therapy

Personalized in-person cognitive-behavioral therapy (CBT) follows a manual drawing on previously published protocols and meta-analyses on effective components of CBT for pediatric anxiety disorders and results from our pilot study. It consists of 12 weekly one-hour sessions delivered over a maximum of 14 weeks. It follows a disorder-specific CBT approach, with a strong emphasis on therapist-led exposure tailored to the patient's principal anxiety disorder. Participants receive workbooks containing information on anxiety disorders, the treatment rationale, and the rationale for exposure therapy. The intervention has three phases: \[1\] 1-2 sessions of psychoeducation and symptom identification, \[2\] 8-10 sessions of therapist-led exposure with homework, and \[3\] 1-2 sessions of relapse prevention planning. Caregiver involvement is tailored to the individual needs of each participant, with a maximum of 2 additional hours allocated for caregivers beyond the standard treatment time.


Locations(1)

Forskningsmottagning Barn och ungdomspsykiatri Lund

Lund, Sweden

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NCT06942429


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