Child and Adolescent Anxiety Disorders (CAMS)

August 21, 2017 updated by: Johns Hopkins University

Child/Adolescent Anxiety Multimodal Treatment Study

This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.

During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Phase 3

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

  • United States
    • California
      • Los Angeles, California, United States
        • UCLA
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • New York
      • New York, New York, United States
        • NYSPI/Columbia University
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Temple University
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh/WPIC

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

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria:

  • Major neurological disorder or medical illness that would interfere with participation in the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sertraline
Participants received sertraline for 12 weeks.
Drug: Sertraline (SRT)
Participants were treated with sertraline.
Other Names:
  • Zoloft
Active Comparator: CBT
Participants received cognitive behavioral therapy for 12 weeks
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received CBT.
Active Comparator: SRT + CBT
Participants received both sertraline and CBT for 12 weeks.
Drug: Sertraline (SRT)
Participants were treated with sertraline.
Other Names:
  • Zoloft
Behavioral: Cognitive Behavioral Therapy (CBT)
Participants received CBT.
Placebo Comparator: Placebo
Participants received a placebo pill for 12 weeks.
Drug: Placebo
Participants were treated with a placebo pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Improvement Scale
Time Frame: Measured at Week 12
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1-Very much improved; 2-Much improved; 3-Minimally improved; 4-No change; 5-Minimally worse; 6-Much worse; 7-Very much worse. Response rates are reported as a percentage of participants who score 1-Very much improved; 2-Much improved on the The Clinical Global Impression - Improvement scale.
Measured at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 22, 2003

First Submitted That Met QC Criteria

January 22, 2003

First Posted (Estimate)

January 23, 2003

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH064089 (U.S. NIH Grant/Contract)
  • DSIR 84-CTP (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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