Clinical trial NCT06016907: Stepped vs Stratified Care for Pediatric Anxiety Disorders
Official title: A Pilot Randomized Controlled Trial of Stepped vs Stratified Care for Pediatric Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety Disorders
Children
Adolescents
Cognitive behavioral therapy
RCT
Care pathway
Stepped care
Stratified care
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-08-30
Enrollment: 51
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Secondary outcomes:
measure: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33).
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Number of participants with concomitant interventions
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33).
measure: Measure of accidental unmasking
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33).
measure: Guess of group allocation
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33).
measure: Experiences of participating in the study
timeFrame: POST-2 (week 30-33).
measure: Interviews with participants about treatment
timeFrame: POST-1 (week 14-17) or POST-2 (week 30-33).
measure: Revised Child Anxiety and Depression Scale - Child version (RCADS-C)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Deliberate Self-harm Inventory - Youth version (DSHI-Y)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Child version (IDAS-II-C)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Child Health Utility 9D (CHU9D)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Systematic Clinical Outcome and Routine Evaluation-15 - Child version (SCORE-15-C)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Need for treatment - Child version
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Client Satisfaction Questionnaire - Child version (CSQ-8-C)
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).
measure: Adverse events questionnaire - Child version (AEQ-C)
timeFrame: Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
measure: Working alliance - Child version
timeFrame: Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
measure: Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Systematic Clinical Outcome and Routine Evaluation-15 - Parent version (SCORE-15-P)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Parent version (IDAS-II-P)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Need for treatment - Parent version
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: The Treatment Inventory of Costs in Patients With Psychiatric Disorders (TIC-P)
timeFrame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
measure: Client Satisfaction Questionnaire - Parent version (CSQ-8-P)
timeFrame: POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).
measure: Adverse events questionnaire - Parent version (AEQ-P)
timeFrame: Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
measure: Working alliance - Parent version
timeFrame: Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
measure: Behavioral, Emotional, and Social Skills Inventory (BESSI)
timeFrame: Week 1; POST-2 (week 30-33).
measure: The PROMIS peer relationships short form (PR-SF)
timeFrame: Week 1; POST-2 (week 30-33).
measure: Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)
timeFrame: Week 1; POST-2 (week 30-33).
measure: The Cognitive-attentional Syndrome Questionnaire (CAS-1)
timeFrame: Week 1; POST-2 (week 30-33).
measure: Hierarchical Personality Inventory for Children (HiPIC-30)
timeFrame: Week 1.
measure: Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
timeFrame: Week 1; POST-2 (week 30-33).
measure: Autism Phenotype Scale (APS)
timeFrame: Week 1; POST-2 (week 30-33).
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Child and Adolescent Mental Health Services, Region Skane
state: Skane
Study officials:
affiliation: Region Skane and Lund University
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: