Separation Anxiety DisorderPhase 2NCT00735995
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
A Phase 2 study testing Cognitive behavioral therapy (individual) and Cognitive behavioral therapy (group) in people with Separation Anxiety Disorder and Social Phobia, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.
Trial summary
The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
- What is being tested?
- Cognitive behavioral therapy (individual) and Cognitive behavioral therapy (group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 3 sitesNorway
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria
Who cannot join
- Pervasive Developmental Disorder
- Psychotic symptoms
- Intelligence score < 70
- Use of medications with anxiety reducing effects during treatment
- Neither parent competent in Norwegian language
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Akershus Universitetssykehus HF
Lorenskog, 1478
Sykehuset Asker og Baerum, Baerum BUP
Rud, 1309
Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
Skien
About this study
Official title: Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.
The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy.
- Being tested
- Cognitive behavioral therapy (individual), Cognitive behavioral therapy (group)
- Medical subject headings
- Anxiety, Separation, Phobia, Social, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (individual)Behavioural
The Coping Cat program, 12 weekly sessions, two additional parent meetings
Cognitive behavioral therapy (group)Behavioural
The Coping Cat program, 12 weekly sessions, two additional parent meetings
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Individual CBT Receives: Behavioral: Cognitive behavioral therapy (individual) |
| B | Experimental | Group CBT Receives: Behavioral: Cognitive behavioral therapy (group) |
| C | No intervention | Waiting-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth
Measured: post-treatment and 2 year follow-up
Secondary outcomes (2)
Symptom score on the MASC
Measured: post-treatment and 2 year follow-up
CGAS
Measured: post-treatment and 2 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 posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Separation Anxiety DisorderStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
- Investigators
- Simon-Peter Neumer, dr.philos, Principal investigator, Regionsenter for barn og unges psykiske helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735995
- Sponsor's protocol ID
- 186036/V50
- Other IDs
- 186036
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2008
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gere MK, Hagen KA, Villabo MA, Arnberg K, Neumer SP, Torgersen S. Fathers' mental health as a protective factor in the relationship between maternal and child depressive symptoms. Depress Anxiety. 2013 Jan;30(1):31-8. doi: 10.1002/da.22010. Epub 2012 Oct 25.
PubMed 23108976Villabo MA, Cummings CM, Gere MK, Torgersen S, Kendall PC. Anxious youth in research and service clinics. J Anxiety Disord. 2013 Jan;27(1):16-24. doi: 10.1016/j.janxdis.2012.09.003. Epub 2012 Sep 25.
PubMed 23257654Villabø MA, Gere MK, Torgersen S, Arnberg K, Neumer SP, Kendall PC. Anxious self-statements in clinic-referred US and Norwegian anxiety-disordered youth. Cognitive Therapy and Research 37(4): 840-850, 2013.
Gere MK, Villabo MA, Torgersen S, Kendall PC. Overprotective parenting and child anxiety: the role of co-occurring child behavior problems. J Anxiety Disord. 2012 Aug;26(6):642-9. doi: 10.1016/j.janxdis.2012.04.003. Epub 2012 May 14.
PubMed 22659077Villabo M, Gere M, Torgersen S, March JS, Kendall PC. Diagnostic efficiency of the child and parent versions of the Multidimensional Anxiety Scale for Children. J Clin Child Adolesc Psychol. 2012;41(1):75-85. doi: 10.1080/15374416.2012.632350.
PubMed 22233247Villabo MA, Narayanan M, Compton SN, Kendall PC, Neumer SP. Cognitive-behavioral therapy for youth anxiety: An effectiveness evaluation in community practice. J Consult Clin Psychol. 2018 Sep;86(9):751-764. doi: 10.1037/ccp0000326.
PubMed 30138014
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group and Individual Treatment of Childhood Anxiety Disorders in Community Clinics. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00735995
- Acronym / sponsor ID
- 186036/V50
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Aug 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Aug 2008 (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 assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Cognitive behavioral therapy (individual)Individual CBT |
| B | Experimental | Behavioral: Cognitive behavioral therapy (group)Group CBT |
| C | No intervention | –Waiting-list control |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria
Key exclusion criteria (5 listed)
- Pervasive Developmental Disorder
- Psychotic symptoms
- Intelligence score < 70
- Use of medications with anxiety reducing effects during treatment
- Neither parent competent in Norwegian language
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 |
|---|---|---|
| Cognitive behavioral therapy (individual)The Coping Cat program, 12 weekly sessions, two additional parent meetings | Behavioural | A |
| Cognitive behavioral therapy (group)The Coping Cat program, 12 weekly sessions, two additional parent meetings | Behavioural | B |
Primary outcome
Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth
Time frame: post-treatment and 2 year follow-up
2 secondary outcomes
Symptom score on the MASC
Time frame: post-treatment and 2 year follow-up
CGAS
Time frame: post-treatment and 2 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Results publication: PubMed 23108976Gere MK, Hagen KA, Villabo MA, Arnberg K, Neumer SP, Torgersen S. Fathers' mental health as a protective factor in the relationship between maternal and child depressive symptoms. Depress Anxiety. 2013 Jan;30(1):31-8. doi: 10.1002/da.22010. Epub 2012 Oct 25.
- Results publication: PubMed 23257654Villabo MA, Cummings CM, Gere MK, Torgersen S, Kendall PC. Anxious youth in research and service clinics. J Anxiety Disord. 2013 Jan;27(1):16-24. doi: 10.1016/j.janxdis.2012.09.003. Epub 2012 Sep 25.
- Results publicationVillabø MA, Gere MK, Torgersen S, Arnberg K, Neumer SP, Kendall PC. Anxious self-statements in clinic-referred US and Norwegian anxiety-disordered youth. Cognitive Therapy and Research 37(4): 840-850, 2013.
- Results publication: PubMed 22659077Gere MK, Villabo MA, Torgersen S, Kendall PC. Overprotective parenting and child anxiety: the role of co-occurring child behavior problems. J Anxiety Disord. 2012 Aug;26(6):642-9. doi: 10.1016/j.janxdis.2012.04.003. Epub 2012 May 14.
- Results publication: PubMed 22233247Villabo M, Gere M, Torgersen S, March JS, Kendall PC. Diagnostic efficiency of the child and parent versions of the Multidimensional Anxiety Scale for Children. J Clin Child Adolesc Psychol. 2012;41(1):75-85. doi: 10.1080/15374416.2012.632350.
- Results publication: PubMed 30138014Villabo MA, Narayanan M, Compton SN, Kendall PC, Neumer SP. Cognitive-behavioral therapy for youth anxiety: An effectiveness evaluation in community practice. J Consult Clin Psychol. 2018 Sep;86(9):751-764. doi: 10.1037/ccp0000326.
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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.
Simon-Peter Neumer, dr.philos principal investigator
Regionsenter for barn og unges psykiske helse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive behavioral therapy (individual) and Cognitive behavioral therapy (group) in people with Separation Anxiety Disorder and Social Phobia, run by Regionsenter for barn og unges psykiske helse at 3 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth (time frame: post-treatment and 2 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735995, which also lists 6 linked publications.
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 26 Sep 2018.