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Technology and Early Anxiety Treatment

NCT03255122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-07-02

No results posted yet for this study

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.

Conditions

  • Anxiety Disorders

Interventions

BEHAVIORAL

I-CALM

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.

BEHAVIORAL

Delayed I-CALM

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

Sponsors & Collaborators

  • Andrew Kukes Foundation for Social Anxiety

    collaborator UNKNOWN

  • Florida International University

    lead OTHER

Principal Investigators

  • Jonathan S Comer, PhD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2020-01-22
Completion
2020-04-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255122 on ClinicalTrials.gov