CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
I-CALM +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03255122
NCT03255122N/ACompleted

Harnessing Technology to Extend the Reach of Supported Care for Families Affected by Early Child Social Anxiety

Florida International University·interventional·Posted Aug 21, 2017·Updated Jul 2, 2020

In Brief

A clinical study evaluating I-CALM and Delayed I-CALM for Anxiety Disorders. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of the study is to evaluate the efficacy of an Internet-delivered format of an evidence-based CBT treatment for early social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. In a randomized controlled trial (RCT), the proposed work will evaluate 40 youth with social anxiety disorder (ages 3-8); 20 will receive the CALM Program over the Internet (I-CALM) and 20 will be assigned to a waitlist control and will complete a course of I-CALM after the waitlist period. Outcomes will be assessed via structured diagnostic interviews and parent-report questionnaires.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 21, 2017
Enrollment StartNov 3, 2016
Primary CompletionJan 22, 2020
Study CompletionApr 22, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 8.9 years ago

Interventions

I-CALMbehavioral

Families receiving I-CALM will immediately receive a videoconferencing-based, Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program; Puliafico, Comer, \& Albano, 2013) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior.

Delayed I-CALMbehavioral

Families receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program.