Anxiety DisordersTADCAROCNCT02218996
Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics
An observational study of Anxiety Disorders, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Psychosocial treatment
- How many people
- 260 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children/adolescents from 7-17 years old referred to ordinary outpatient mental health service.
Who may be able to join
- 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.
Who cannot join
- The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety Disorders
- Being tested
- Psychosocial treatment
- Keywords
- Anxiety, Children, Adolescent, Effectiveness, Outpatient
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial treatmentOther
Regular psychosocial treatment in clinical outpatient service.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial treatment | Children and adolescents with anxiety disorders Receives: Other: Psychosocial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996).
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.
Measured: The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
Secondary outcomes (6)
Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
Clinical Global Impressions (CGI; Guy, 1976).
Measured: The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse Vest
- Responsible party
- Sponsor
- Investigators
- Jon F Bjaastad, D. Psych, Principal investigator, Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218996
- Sponsor's protocol ID
- ID416
- Acronym
- TADCAROC
- Status last verified
- Dec 2024
- First submitted
- 8 Aug 2014
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)
- ClinicalTrials.gov ID
- NCT02218996
- Acronym / sponsor ID
- TADCAROC / ID416
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Children, Adolescent, Effectiveness, Outpatient
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse Vest
- Study start
- Aug 2014 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial treatment | – | Other: Psychosocial treatmentChildren and adolescents with anxiety disorders |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children/adolescents from 7-17 years old referred to ordinary outpatient mental health service.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial treatmentRegular psychosocial treatment in clinical outpatient service. | Other | Psychosocial treatment |
Primary outcome
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.
6 secondary outcomes
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).
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).
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).
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon F Bjaastad, D. Psych principal investigator
Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.