- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580081
Optimizing CBT Implementation Among Community Providers Through Internet-based Consultation and Networking (i-CAN)
April 1, 2025 updated by: University of Alabama, Tuscaloosa
Although anxiety is one of the most common and debilitating mental health conditions affecting children and adolescents, the vast majority of sufferers do not receive effective treatment.
Cognitive-behavioral therapy (CBT) is an evidence-based, frontline treatment for pediatric anxiety, yet many community-based practitioners do not implement CBT with high fidelity, which can detrimentally affect its clinical impact.
The goal of this study is to develop and test an online platform to support community providers' effective use of CBT for pediatric anxiety.
Study Overview
Detailed Description
Stemming from implementation science and, specifically, the Theory of Planned Behavior, investigators are working alongside community stakeholders to develop a novel, online consultation platform.
This platform, termed Internet-based Consultation or Networking (or i-CAN) will utilize a professional navigator (i.e., a provider with CBT expertise), online support and resources, and parallel peer consultation to create a user-friendly and supportive community for providers to get support as they implement CBT.
Once finalized, the platform will be tested in the context of a preliminary randomized controlled trial (RCT) with approximately 100 mental healthcare providers who work with anxious children and adolescents.
Providers who enroll will be randomly assigned to either the experimental condition (i-CAN) or the control condition (wait-list for i-CAN).
The primary outcome of interest is change in intentions to use CBT.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35487
- Center for Youth Development and Intervention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- provide direct mental healthcare to anxious youth
- practice in general community within state of Alabama
- agree to try i-CAN
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: i-CAN
18 weeks of access to the online consulting platform
|
online support and consultation to providers
|
|
No Intervention: waitlist control
No offered support or consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reasoned Action Questionnaire
Time Frame: 18 weeks
|
Questionnaire that assesses instrumental beliefs, perceived norms, and self-efficacy (all related to use of cognitive-behavioral therapy).
On the Reasoned Action Questionnaire, higher scores indicate greater intention to use the therapeutic approach.
Scores can range from 14 to 90.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evidence-based practice attitude scale
Time Frame: 18 weeks
|
Questionnaire that assesses views toward cognitive-behavioral therapy.
Higher scores indicate more positive views.
Scores can range from 0 to 60.
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan W White, PhD, UA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
December 1, 2024
Study Completion (Actual)
February 1, 2025
Study Registration Dates
First Submitted
October 11, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
April 1, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- A22-0473
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be shared to NDA, and data requests can be issued directly to NDA.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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