Stepped vs Stratified Care for Pediatric Anxiety Disorders (PMAX)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety Disorders
• Intervention / Treatment: Behavioral: Internet-delivered cognitive behavioral therapy (ICBT); Behavioral: In-person cognitive behavioral therapy (CBT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Serlachius, MD, PhD; Phone Number: +46 70 715 52 32; Email: eva.serlachius@med.lu.se
• Study Contact Backup: Name: Per Andrén, PhD; Phone Number: +46 70 435 17 40; Email: per.andren@med.lu.se

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • Child and Adolescent Mental Health Services, Region Skane
      • Contact: Per Andrén, PhD; Phone Number: +46 70 435 17 40; Email: per.andren@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Internet-delivered cognitive behavioral therapy (ICBT); Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.; Behavioral: In-person cognitive behavioral therapy (CBT); Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.
Other: 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.	Behavioral: Internet-delivered cognitive behavioral therapy (ICBT); Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.; Behavioral: In-person cognitive behavioral therapy (CBT); Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)	Used to assess anxiety disorders and psychiatric comorbidity at baseline and anxiety disorders and major depression at follow-ups. Clinician-rated.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Clinical Global Impression Scale - Severity (CGI-S)	Used to assess overall anxiety severity. Clinician-rated. Ratings are reported on a seven-graded scale from 1 ("Normal, not at all ill") to 7 ("Among the most extremely ill patients").	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Clinical Global Impression Scale - Improvement (CGI-I)	Used to assess level of improvement compared to admission. Clinician-rated. This single item scale ranges from 1 ("Very much improved") to 7 ("Very much worse").	POST-1 (week 14-17); POST-2 (week 30-33).
Children's Global Assessment Scale (CGAS)	Used to assess global impairment. Clinician-rated. The CGAS is a single item scale that ranges from 1 to 100, with a higher value indicating better functioning.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Measure of accidental unmasking	Used to assess the number of occasions where outcome assessors are accidentally unmasked to group allocation.	POST-1 (week 14-17); POST-2 (week 30-33).
Guess of group allocation	Used to assess the percentage of correctly guessed group allocation from masked outcome assessors.	POST-1 (week 14-17); POST-2 (week 30-33).
Experiences of participating in the study	A semi-structured interview conducted by a non-masked study coordinator covering (i) burden of participation, (ii) experiences of interventions, (iii) understandability of measures/interviews, and (iv) missing content in measures/interviews. Clinician-rated.	POST-2 (week 30-33).
Interviews with participants about treatment	A semi-structured interview conducted by a non-masked researchers who is not otherwise involved in the study covering topics about treatment content, treatment timing, degree of therapist contact, caregiver collaboration and personal effort/motivation as well as themes important to the child/adolescent. Clinician-rated.	POST-1 (week 14-17) or POST-2 (week 30-33).
Revised Child Anxiety and Depression Scale - Child version (RCADS-C)	Used to assess anxiety symptoms. Child/adolescent-reported. The RCADS version used in the present study is the 47-item version which ranges from 0 to 141 points, with higher scores indicating more severe internalizing symptoms.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Child Anxiety Life Interference Scale - Revised - Child version (CALIS-R-C)	Used to assess life interference and impairment associated with childhood anxiety. The scale ranges from 0 to 36 points, with higher scores indicating higher interference and impairment.Child/adolescent-reported.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Deliberate Self-harm Inventory - Youth version (DSHI-Y)	Used to assess self-harm. Child/adolescent-reported.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Child Health Utility 9D (CHU9D)	Used to assess health-related quality of life. Child/adolescent-reported. The scale ranges from 9 to 45 points, with higher scores indicating worse quality of life.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Need for treatment - Child version	Used to assess need of treatment for anxiety symptoms. Child/adolescent-reported. This single item scale ranges from 1 to 5 points, with higher scores indicating a higher need for treatment.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Client Satisfaction Questionnaire - Child version (CSQ-8-C)	Used to assess treatment satisfaction. Child/adolescent-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.	POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).
Working alliance - Child version	Used to assess the participant's perceived working alliance with their therapist. Child/adolescent-reported. The scale ranges from 0 to 36 points, with higher scores indicating better working alliance.	Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
Revised Child Anxiety and Depression Scale - Parent version (RCADS-P)	Used to assess anxiety symptoms. Caregiver-reported. The RCADS version used in the present study is the 47-item version which ranges from 0 to 141 points, with higher scores indicating more severe internalizing symptoms.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Child Anxiety Life Interference Scale - Revised - Parent version (CALIS-R-P)	Used to assess life interference and impairment associated with childhood anxiety. Caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating higher interference and impairment.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Need for treatment - Parent version	Used to assess need of treatment for anxiety symptoms. Caregiver-reported. This single item scale ranges from 1 to 5 points, with higher scores indicating a higher need for treatment.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
The Treatment Inventory of Costs in Patients With Psychiatric Disorders (TIC-P)	Used to assess healthcare and other societal resource use for both children and caregivers. Caregiver-reported.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Client Satisfaction Questionnaire - Parent version (CSQ-8-P)	Used to assess treatment satisfaction. Caregiver-reported. The scale ranges from 9 to 36 points, with higher scores indicating greater satisfaction.	POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).
Working alliance - Parent version	Used to assess the caregiver's perceived working alliance with their therapist. Caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating better working alliance.	Every third week during weeks 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
Number of participants with concomitant interventions	Used to assess potential other treatments during the study period. Clinician-rated.	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)	Used to assess irritability. Child/adolescent-reported. The scale ranges from 0 to 20 points, with higher scores indicating greater anger.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Systematic Clinical Outcome and Routine Evaluation-15 - Child version (SCORE-15-C)	Used to assess family functioning. Child/adolescent-reported. The scale ranges from 15 to 75, with a lower score indicating higher family functioning.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Adverse events questionnaire - Child version (AEQ-C)	Used to assess adverse events/effects. Child/adolescent-reported. The scale consists of 22 yes/no items (score range 0-22 points) with higher scores indicating more present adverse events. For each adverse event that is present, there is also a rating of whether the adverse event is thought to be related to the provided treatment (yes or no).	Every third week during week 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)	Used to assess family functioning. Caregiver-reported. The scale ranges from 15 to 75, with a lower score indicating higher family functioning.	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)	Used to assess irritability. Caregiver-reported. The scale ranges from 0 to 20 points, with higher scores indicating greater anger.	Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Adverse events questionnaire - Parent version (AEQ-P)	Used to assess adverse events/effects. Parent-reported. The scale consists of 22 yes/no items (score range 0-22 points) with higher scores indicating more present adverse events. For each adverse event that is present, there is also a rating of whether the adverse event is thought to be related to the provided treatment (yes or no).	Every third week during week 2-13 and 18-29 (the latter applies only if a second round of treatment is initiated).
Behavioral, Emotional, and Social Skills Inventory (BESSI)	Used to assess emotional resilience and self-management. Child/adolescent and caregiver-reported. The scale consists of 102 items, each rated from 1 to 5 points, and scores are presented as averages on six different combinations of items, referred to as "Skill domains".	Week 1; POST-2 (week 30-33).
The PROMIS peer relationships short form (PR-SF)	Used to assess peer relationships. Child/adolescent-reported. The scale ranges from 8 to 40 points, with higher scores indicating greater peer relationships.	Week 1; POST-2 (week 30-33).
Avoidance and Fusion Questionnaire for Youth (AFQ-Y8)	Used to assess psychological inflexibility. Child/adolescent-reported. The scale ranges from 0 to 32 points, with higher scores indicating greater psychological inflexibility.	Week 1; POST-2 (week 30-33).
The Cognitive-attentional Syndrome Questionnaire (CAS-1)	Used to assess dysfunctional metacognitive beliefs. Child/adolescent-reported. The questionnaire consists of four domains. Each item of the three first domains is scored on a 0-8 point scale. Each item of the fourth domain is score on 0-100 scale. Higher scores indicates more dysfunctional metacognitive beliefs.	Week 1; POST-2 (week 30-33).
Hierarchical Personality Inventory for Children (HiPIC-30)	Used to assess personality traits. Child/adolescent and caregiver-reported. The questionnaire collects data on five personality domains. Each of the 30 items range from 1 to 5 points. Higher scores indicates greater indication of the personality domain in question.	Week 1.
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)	Used to assess attention difficulties, hyperactivity, impulsivity, and oppositional symptoms. Caregiver-reported. Each item is scored from 0 to 3 points. The item scores are then summarized in domains: inattention (items 1-9), hyperactivity-impulsivity (items 11-19) and oppositional (items 21-28). Items 10, 20 and 29 are not included in any of the domains. Higher scores indicate greater attention difficulties, hyperactivity, impulsivity, and oppositional symptoms.	Week 1; POST-2 (week 30-33).
Autism Phenotype Scale (APS)	Used to assess core autism traits. Child/adolescent and caregiver-reported. The scale ranges from 0 to 36 points, with higher scores indicating greater autism traits.	Week 1; POST-2 (week 30-33).

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Eva Serlachius, MD, PhD, Region Skane and Lund University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive behavioral therapy; Children; RCT; Care pathway; Anxiety Disorders; Stratified care; Stepped care
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022-07219-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymised and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for research purposes. The data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No