NCT05580081

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

October 11, 2022

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reasoned Action Questionnaire

    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 Outcomes (1)

  • Evidence-based practice attitude scale

    18 weeks

Study Arms (2)

i-CAN

EXPERIMENTAL

18 weeks of access to the online consulting platform

Behavioral: i-CAN

waitlist control

NO INTERVENTION

No offered support or consultation

Interventions

i-CANBEHAVIORAL

online support and consultation to providers

i-CAN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • provide direct mental healthcare to anxious youth
  • practice in general community within state of Alabama
  • agree to try i-CAN

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Youth Development and Intervention

Tuscaloosa, Alabama, 35487, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Susan W White, PhD

    UA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The RCT is a parallel group design, in which those in Control will be offered i-CAN after the 18 week waiting period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

April 1, 2023

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Data will be shared to NDA, and data requests can be issued directly to NDA.

Locations