Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)

May 15, 2023 updated by: Helse Stavanger HF

Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)

The purpose of this study is to examine the content of the treatment being delivered for anxiety disorders for children and adolescents in the regular outpatient clinics in western Norway. The study will also collect data before and after treatment to evaluate the result of the treatment. Furthermore, as part of the study we aim to collect normative data on two questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere with daily functioning. We also aim to develop a quality indicator for anxiety treatment that can be used to monitor treatment in the regular outpatient service, based on the results of the current study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

260

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

    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • BUPA Helse Stavanger

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

Sampling Method

Non-Probability Sample

Study Population

Children/adolescents from 7-17 years old referred to ordinary outpatient mental health service.

Description

Inclusion Criteria:

  • Clinical diagnosis of an anxiety disorder (including PTSD and OCD) based on the diagnostic interview ADIS (ADIS-C/P; Silverman & Albano, 1996).
  • The anxiety disorder is the patients primary diagnosis.
  • Informed concent is given.

Exclusion Criteria:

  • The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psychosocial treatment
Children and adolescents with anxiety disorders
Regular psychosocial treatment in clinical outpatient service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996).
Time Frame: The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
Diagnostic interview for anxiety disorders and other comorbid disorders. For the 10-year follow-up we anticipate to use another version of the diagnostic interview schedule based on revised diagnostic criteria for anxiety disorders.
The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.

Secondary Outcome Measures

Outcome Measure
Time Frame
Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
The Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1999).
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
Spence Children's Anxiety Scale (SCAS; Spence, 1998)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
Short Mood & Feeling Questionaire (SMFQ; Angold et al., 1995).
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
Clinical Global Impressions (CGI; Guy, 1976).
Time Frame: The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Jon F Bjaastad, D. Psych, Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway

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)

August 1, 2014

Primary Completion (Anticipated)

December 31, 2028

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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