Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016907
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-08-16
Brief Title:
Stepped vs Stratified Care for Pediatric Anxiety Disorders
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of Stepped vs Stratified Care for Pediatric Anxiety Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMAX
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 andor 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None