Clinical trial NCT06942429: Stepped Versus Stratified Care for Anxiety Disorders in Youth
Official title: Stepped Versus Stratified Care for Anxiety Disorders in Youth: A Pragmatic Non-Inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Separation Anxiety Disorder
Specific Phobia
Panic Disorder
Generalized Anxiety Disorder
Agoraphobia
Keywords: anxiety disorders
children
adolescents
cognitive behavioral therapy
non-inferiority
care models
stepped care
stratified care
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2025-04-24
Enrollment: 556
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A detailed description is available in the full study protocol. All study protocol versions can be accessed at the Open Science Framework (https://osf.io/a9qhw/).

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.

Primary outcomes:
measure: Clinical Global Impressions - Improvement Scale
timeFrame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Secondary outcomes:
measure: Pediatric Anxiety Rating Scale
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders - Child and Adolescent Version
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
measure: Clinical Global Impressions Scale-Severity
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
measure: Children's Global Assessment Scale
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
measure: Revised Children's Anxiety and Depression Scale
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
measure: Child Anxiety Life Interference Scale-Revised
timeFrame: Baseline; 4 months (17 to 20 weeks post-randomization); 8 months (35 to 40 weeks post-randomization, primary endpoint); 12 months; 24 months
measure: Proportion of participants who do not adhere to the assigned treatment/s
timeFrame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
measure: Adverse events
timeFrame: 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint)
Other outcomes:
measure: Health economic outcomes
timeFrame: Baseline; 4 months (17-20 weeks post-randomization); 8 months (35-40 weeks post-randomization, primary endpoint); 12 months (53-60 weeks post-randomization, observational follow-up); 24 months (105-116 weeks post-randomization, observational follow-up)
Locations:
city: Lund
country: Sweden
facility: Forskningsmottagning Barn och ungdomspsykiatri Lund
Study officials:
affiliation: Lund University & CAMHS Skåne
name: Matti Cervin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University & CAMHS Skåne
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: