Stepped vs Stratified Care for Pediatric Anxiety Disorders

NCT06016907 | Completed

• 1 other identifier: 2022-07219-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders

Keywords

Anxiety Disorders; Children; Adolescents; Cognitive behavioral therapy; RCT; Care pathway; Stepped care; Stratified care

Outcome Measures

Primary Outcomes (1)

• Pediatric Anxiety Rating Scale (PARS)

  Used to assess anxiety severity. Clinician-rated. Primary clinical outcome of the study. The scale yields a score of 0 to 35, with higher scores indicating more severe anxiety.

  Baseline; POST-1 (week 14-17); POST-2 (week 30-33).

Secondary Outcomes (35)

• Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

  Baseline; POST-1 (week 14-17); POST-2 (week 30-33).

• Clinical Global Impression Scale - Severity (CGI-S)

  Baseline; POST-1 (week 14-17); POST-2 (week 30-33).

• Clinical Global Impression Scale - Improvement (CGI-I)

  POST-1 (week 14-17); POST-2 (week 30-33).

• Children's Global Assessment Scale (CGAS)

  Baseline; POST-1 (week 14-17); POST-2 (week 30-33).

• Number of participants with concomitant interventions

  POST-1 (week 14-17); POST-2 (week 30-33).

Study Arms (2)

Stepped care

OTHER

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.

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT); Behavioral: In-person cognitive behavioral therapy (CBT)

Stratified care

OTHER

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.

Behavioral: Internet-delivered cognitive behavioral therapy (ICBT); Behavioral: In-person cognitive behavioral therapy (CBT)

Interventions

Internet-delivered cognitive behavioral therapy (ICBT) BEHAVIORAL

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

Stepped care; Stratified care

In-person cognitive behavioral therapy (CBT) BEHAVIORAL

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

Stepped care; Stratified care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to \<18 years of age.
• 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.
• A Clinical Global Impression Scale - Severity (CGI-S) score \>3 in relation to severity of all anxiety symptoms.
• Child and caregiver able to read, write and communicate in Swedish.
• An available caregiver who can support the child in treatment.
• Access to the internet.
• Ability to attend treatment sessions at the clinic.

You may not qualify if:

• 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).
• Established or suspected intellectual disability.
• 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).
• Social/familial/educational difficulties in more immediate need of management than an anxiety disorder.
• Ongoing psychological treatment for an anxiety disorder.
• 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.
• Immediate risk to self or others that require urgent attention, such as suicidality.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Child and Adolescent Mental Health Services, Region Skane

Lund, Skåne County, 22185, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Eva Serlachius, MD, PhD

  Region Skane and Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 30, 2023
• Study Start: October 2, 2023
• Primary Completion: October 30, 2024
• Study Completion: November 14, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

SE (1)