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Stepped vs Stratified Care for Pediatric Anxiety Disorders

NCT ID: NCT06016907

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-11-14

Brief Summary

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The purpose of this trial is to evaluate the feasibility, acceptability, and safety of two care pathways (including internet-delivered cognitive behavioral therapy \[CBT\] and/or in-person CBT) for children and adolescents with anxiety disorders.

Detailed Description

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Introduction: Anxiety disorders are a major contributor to disability in children and adolescents. Cognitive behavioral therapy (CBT), delivered both in-person and by the internet (ICBT), is efficacious, but how to best organize the care pathway to increase access and benefit is unclear.

Methods: With the aim to conduct a fully powered randomized controlled trial, the present study is a randomized controlled, single-blind, pilot study where 50 youth with anxiety disorders and their caregivers will be randomized (1:1) to stepped care or stratified care. Stepped and stratified care are two competing service delivery models which include evidence-based interventions but differ regarding the timing and staging of interventions.

In the stepped care arm, all participants will begin with 12 modules of ICBT delivered over 12 weeks. Participants with an insufficient response will then be offered 12-weeks of personalized in-person CBT. In the stratified care arm, the investigators aim to offer about half of the participants ICBT and the other half in-person CBT, with this selection being based on a risk score algorithm that integrates known predictors of non-response to treatment.

Mirroring the structure in stepped care, all non-responders in stratified care (both those who started with ICBT and in-person CBT) will be offered an additional 12-week course of in-person CBT. The ICBT and in-person CBT interventions will be identical in treatment length, but will differ in the delivery of treatment, utilizing the possibility of increased personalization and therapist-involvement in in-person CBT.

The objectives of the pilot study are to examine feasibility, acceptability, and safety of study procedures, precision of the risk score algorithm, and statistical properties of outcome measures. The feasibility, acceptability, and safety objectives are operationalized in detail in the full study protocol published at the Open Science Framework (OSF; see link in the References-section at the bottom of this record).

Data will be collected at baseline, post-allocation (week 1), weekly during treatment course A (week 2-13), after treatment course A (POST-1; time window for data collection between week 14-17), weekly during treatment course B (if applicable, week 18-29), and after treatment course B (POST-2; time window for data collection between week 30-33). POST-2 is the primary endpoint of the study.

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot, single-blind, parallel-group (2 groups), randomized controlled trial for children and adolescents with anxiety disorders. Participants will be randomized at a 1:1 ratio to one out of two care pathways: stepped care and stratified care. Each care pathway consists of up to two courses of treatment.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Assessors conducting follow-up assessments (referred to as POST-1 and POST-2) will be blind to treatment allocation. At each follow-up assessment, participants will be reminded by their assessor to not reveal their study allocation. To measure blinding integrity, all assessors will record whether the participants inadvertently revealed their group allocation, and subsequently guess each participant's treatment allocation at each assessment point and motivate their choice. If the treatment allocation is accidentally revealed, the revelation part will be cut out of the Pediatric Anxiety Rating Scale audio recording and a new blind assessor will listen to the audio recording and conduct the rating that will be used in the trial. Subsequent assessments for that participant will then be conducted by someone different than the unblinded assessor. The primary analysis will be performed after the study's final participant has finished his/her POST-2 assessment.

Study Groups

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Stepped care

Participants will receive up to two courses of treatment. All participants in stepped care will receive internet-delivered cognitive behavioral therapy (ICBT) in the first course (A). Participants with an insufficient treatment response will then be offered in-person cognitive behavioral therapy (CBT) in the second course (B). Even if participants are offered treatment in course B, participants are free to decline this offer, and will instead only be invited to the remaining outcome assessments.

Group Type OTHER

Internet-delivered cognitive behavioral therapy (ICBT)

Intervention Type BEHAVIORAL

Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.

In-person cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.

Stratified care

Participants will receive up to two courses of treatment. In stratified care, in treatment course A, the investigators aim to offer around half of the participants ICBT and the other half in-person CBT (based on their risk of non-response). All participants in stratified care who do not sufficiently respond to treatment in course A will be offered personalized in-person CBT in course B. Even if participants are offered treatment in course B, participants are free to decline this offer, and will instead only be invited to the remaining outcome assessments.

Group Type OTHER

Internet-delivered cognitive behavioral therapy (ICBT)

Intervention Type BEHAVIORAL

Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.

In-person cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.

Interventions

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Internet-delivered cognitive behavioral therapy (ICBT)

Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.

Intervention Type BEHAVIORAL

In-person cognitive behavioral therapy (CBT)

Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 8 to \<18 years of age.
2. A principal Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) anxiety disorder of social anxiety disorder, generalized anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, or agoraphobia.
3. A Clinical Global Impression Scale - Severity (CGI-S) score \>3 in relation to severity of all anxiety symptoms.
4. Child and caregiver able to read, write and communicate in Swedish.
5. An available caregiver who can support the child in treatment.
6. Access to the internet.
7. Ability to attend treatment sessions at the clinic.

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).
2. Established or suspected intellectual disability.
3. Another mental disorder in more immediate need of management than an anxiety disorder (e.g., schizophrenia spectrum and other psychotic disorders, bipolar disorder, anorexia nervosa, substance use disorders).
4. Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
5. Ongoing psychological treatment for an anxiety disorder.
6. Initiation or adjustment of any psychotropic medication for anxiety (i.e., selective serotonin reuptake inhibitors, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor or antipsychotics) within 8 weeks prior to assessment.
7. Immediate risk to self or others that require urgent attention, such as suicidality.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Serlachius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skane and Lund University

Locations

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Child and Adolescent Mental Health Services, Region Skane

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Related Links

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https://osf.io/k6j7n/

All full study protocol versions are available at this open repository.

Other Identifiers

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2022-07219-01

Identifier Type: -

Identifier Source: org_study_id