ClinicalTrials.gg
CompletedNCT00735995Updated Sep 26, 2018

Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway

A Phase 2 interventional study of Cognitive behavioral therapy (individual) and Cognitive behavioral therapy (group) in Separation Anxiety Disorder, Social Phobia and Generalized Anxiety Disorder, sponsored by Regionsenter for barn og unges psykiske helse. Completed at 3 sites in Norway. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by Regionsenter for barn og unges psykiske helse · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Separation Anxiety Disorder
  • Social Phobia
  • Generalized Anxiety Disorder
03

In context

Anxiety, Separation

59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.

This study's enrollment of 165 is above the median of 68 across 53 interventional studies indexed under Anxiety, Separation.

Browse Anxiety, Separation studies →

Lead sponsor

Regionsenter for barn og unges psykiske helse is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, criteria

Exclusion criteria

Exclusion Criteria:

  • Pervasive Developmental Disorder
  • Psychotic symptoms
  • Intelligence score \< 70
  • Use of medications with anxiety reducing effects during treatment
  • Neither parent competent in Norwegian language
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    A

    Individual CBT

    Behavioral: Cognitive behavioral therapy (individual)

  • Experimental
    B

    Group CBT

    Behavioral: Cognitive behavioral therapy (group)

  • No intervention
    C

    Waiting-list control

Interventions

  • BehavioralCognitive behavioral therapy (individual)

    The Coping Cat program, 12 weekly sessions, two additional parent meetings

  • BehavioralCognitive behavioral therapy (group)

    The Coping Cat program, 12 weekly sessions, two additional parent meetings

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Symptom score on the MASC

    Time frame: post-treatment and 2 year follow-up

  2. CGAS

    Time frame: post-treatment and 2 year follow-up

07

Study locations

3 sites
  • Akershus Universitetssykehus HF
    Lorenskog, 1478, Norway
  • Sykehuset Asker og Baerum, Baerum BUP
    Rud, 1309, Norway
  • Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP
    Skien, Norway
08

References and documents

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 23108976 ↗
  • Villabo 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 23257654 ↗
  • Villabø 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. Erratum In: J Anxiety Disord. 2013 Mar;27(2):265. PubMed 22659077 ↗
  • Villabo 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 22233247 ↗
  • Villabo 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2008, a primary completion of Oct 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2008
First posted
Aug 15, 2008
Start
Aug 2008
Primary completionActual
Oct 2013
CompletionActual
Dec 2013
Last update
Sep 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00735995
Lead sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
The Research Council of Norway
Responsible party
Simon-Peter Neumer (dr. Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse) — Principal investigator
First posted
Aug 15, 2008
Start date
Aug 2008
Primary completion
Oct 2013
Completion
Dec 2013
Last update
Sep 26, 2018

Study contacts

Simon-Peter Neumer, dr.philos
principal investigator · Regionsenter for barn og unges psykiske helse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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