A Phase 2 interventional study of Cognitive behavioural therapy in Separation Anxiety Disorder, Social Anxiety Disorder and Generalized Anxiety Disorder, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Treatment
The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.
Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.
The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.
There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 222 is above the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions.
Behavioral: Cognitive behavioural therapy
The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions.
Behavioral: Cognitive behavioural therapy
Wait-list control condition for 5 weeks after last child has been included.
The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.
Also known as: FRIENDS
Anxiety disorders according to the ADIS-IV C/P interview
Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
Time frame: Post-treatment and 1 and 5 year follow-up
Anxiety symptom score according to the Spence Children Anxiety Scale
Time frame: Post-treatment, 1 and 5 year follow-up
Depressive symptoms according to the Mood and Feelings Questionnaire
Time frame: Post-treatment, 1 and 5 year follow-up
The record gives a start of Jan 2008, a primary completion of Jun 2012 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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