A Pilot Randomized Controlled Trial of Stepped vs Stratified Care for Pediatric Anxiety Disorders

Region Skane1 site in 1 country51 target enrollmentOctober 2, 2023

ConditionsAnxiety Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: Region Skane
Enrollment: 51
Locations: 1
Primary Endpoint: Pediatric Anxiety Rating Scale (PARS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2, 2023

End Date

November 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Region Skane

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•8 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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Pediatric Anxiety Rating Scale (PARS)

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

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.

Secondary Outcomes

Deliberate Self-harm Inventory - Youth version (DSHI-Y)(Baseline; 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).)
Measure of accidental unmasking(POST-1 (week 14-17); POST-2 (week 30-33).)
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).)
Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Child version (IDAS-II-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Need for treatment - Child version(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Revised Child Anxiety and Depression Scale - Child version (RCADS-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
The Treatment Inventory of Costs in Patients With Psychiatric Disorders (TIC-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Need for treatment - Parent version(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).)
Guess of group allocation(POST-1 (week 14-17); POST-2 (week 30-33).)
Interviews with participants about treatment(POST-1 (week 14-17) or POST-2 (week 30-33).)
Child Health Utility 9D (CHU9D)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Experiences of participating in the study(POST-2 (week 30-33).)
Systematic Clinical Outcome and Routine Evaluation-15 - Child version (SCORE-15-C)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Client Satisfaction Questionnaire - Child version (CSQ-8-C)(POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).)
Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
The PROMIS peer relationships short form (PR-SF)(Week 1; POST-2 (week 30-33).)
Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)(Week 1; POST-2 (week 30-33).)
Hierarchical Personality Inventory for Children (HiPIC-30)(Week 1.)
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)(Week 1; POST-2 (week 30-33).)
Adverse events questionnaire - Child version (AEQ-C)(Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
Working alliance - Child version(Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
Systematic Clinical Outcome and Routine Evaluation-15 - Parent version (SCORE-15-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Ill temper scale of the Inventory of Depression and Anxiety Symptoms II - Parent version (IDAS-II-P)(Baseline; POST-1 (week 14-17); POST-2 (week 30-33).)
Client Satisfaction Questionnaire - Parent version (CSQ-8-P)(POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).)
Adverse events questionnaire - Parent version (AEQ-P)(Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
The Cognitive-attentional Syndrome Questionnaire (CAS-1)(Week 1; POST-2 (week 30-33).)
Autism Phenotype Scale (APS)(Week 1; POST-2 (week 30-33).)
Working alliance - Parent version(Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).)
Behavioral, Emotional, and Social Skills Inventory (BESSI)(Week 1; POST-2 (week 30-33).)