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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
51
Cognitive behavioral therapy (CBT) delivered through an internet platform with therapist support.
Cognitive behavioral therapy (CBT) delivered in-person at a clinic by a therapist.
Child and Adolescent Mental Health Services, Region Skane
Lund, Skåne County, Sweden
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.
Time frame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
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.
Time frame: 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").
Time frame: 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").
Time frame: 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.
Time frame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
Number of participants with concomitant interventions
Used to assess potential other treatments during the study period. Clinician-rated.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Used to assess irritability. Child/adolescent-reported. The scale ranges from 0 to 20 points, with higher scores indicating greater anger.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: POST-1 (week 14-17); POST-2 (week 30-33; only if a second round of treatment is initiated).
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).
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; POST-1 (week 14-17); POST-2 (week 30-33).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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).
Time frame: Every third week during week 2-13 and 18-29 (the latter applies 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.
Time frame: 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)
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1; POST-2 (week 30-33).