Separation Anxiety DisorderPhase 2ATACANCT00586586
Effectiveness Study of CBT for Anxiety in Children
A Phase 2 study testing Cognitive behavioural therapy in people with Separation Anxiety Disorder and Social Anxiety Disorder, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder
- What is being tested?
- Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2008to 21 Mar 2014
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule
Who cannot join
- Pervasive developmental disorders, Selective mutism, Mental retardation
- Having severe obsessional/compulsive, conduct or language problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Treatment - Anxiety in Children and Adults (Child Part)
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.
Read the detailed description
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.
- Being tested
- Cognitive behavioural therapy
- 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 behavioural therapyBehavioural
Also called FRIENDS
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.
| Study group | Role | What they receive |
|---|---|---|
| Group CBT | Experimental | 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. Receives: Behavioral: Cognitive behavioural therapy |
| Individual CBT | Experimental | The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually.
10 weekly sessions plus 2 booster sessions. Receives: Behavioral: Cognitive behavioural therapy |
| Wait-list control | No intervention | Wait-list control condition for 5 weeks after last child has been included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety disorders according to the ADIS-IV C/P interview
Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
Measured: Post-treatment and 1 and 5 year follow-up
Secondary outcomes (2)
Anxiety symptom score according to the Spence Children Anxiety Scale
Measured: Post-treatment, 1 and 5 year follow-up
Depressive symptoms according to the Mood and Feelings Questionnaire
Measured: Post-treatment, 1 and 5 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 posted4 Jan 2008 (estimated)
- Study start2 Jan 2008
- Primary completion1 Jun 2012
- Study completion21 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Separation Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Einar Heiervang, MD, Principal investigator, Haukeland University HospitalGro Janne H Wergeland, MD PhD, Study chair, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586586
- Sponsor's protocol ID
- 17563
- Acronym
- ATACA
- Status last verified
- Aug 2017
- First submitted
- 21 Dec 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Bjaastad JF, Oeding K, Bjelland I, Silverman WK, Ost LG, Havik OE, Heiervang ER. An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth. Behav Res Ther. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.
PubMed 24727078Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Ost LG, Havik OE, Heiervang ER. Predictors of dropout from community clinic child CBT for anxiety disorders. J Anxiety Disord. 2015 Apr;31:1-10. doi: 10.1016/j.janxdis.2015.01.004. Epub 2015 Jan 22.
PubMed 25637909Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Ost LG, Bjaastad JF, Oeding K, Havik OE, Heiervang ER. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders. Behav Res Ther. 2016 Jan;76:1-12. doi: 10.1016/j.brat.2015.11.001. Epub 2015 Nov 5.
PubMed 26583954Kodal A, Fjermestad K, Bjelland I, Gjestad R, Ost LG, Bjaastad JF, Haugland BSM, Havik OE, Heiervang E, Wergeland GJ. Long-term effectiveness of cognitive behavioral therapy for youth with anxiety disorders. J Anxiety Disord. 2018 Jan;53:58-67. doi: 10.1016/j.janxdis.2017.11.003. Epub 2017 Nov 26.
PubMed 29195188Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Ost LG, De Los Reyes A, Havik OE, Haugland BS. Therapist-youth agreement on alliance change predicts long-term outcome in CBT for anxiety disorders. J Child Psychol Psychiatry. 2016 May;57(5):625-32. doi: 10.1111/jcpp.12485. Epub 2015 Dec 9.
PubMed 26647901
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment - Anxiety in Children and Adults (Child Part)
- ClinicalTrials.gov ID
- NCT00586586
- Acronym / sponsor ID
- ATACA / 17563
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 2 Jan 2008
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 21 Mar 2014 (actual)
- First posted
- 4 Jan 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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group CBT | Experimental | Behavioral: Cognitive behavioural therapyThe 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. |
| Individual CBT | Experimental | Behavioral: Cognitive behavioural therapyThe behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions. |
| Wait-list control | No intervention | –Wait-list control condition for 5 weeks after last child has been included. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule
Key exclusion criteria (2 listed)
- Pervasive developmental disorders, Selective mutism, Mental retardation
- Having severe obsessional/compulsive, conduct or language problems.
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 behavioural therapyAlso: FRIENDSThe 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. | Behavioural | Group CBT, Individual CBT |
Primary outcome
Anxiety disorders according to the ADIS-IV C/P interview
Time frame: Post-treatment and 1 and 5 year follow-up
Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.
2 secondary outcomes
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
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 8 Aug 2017.
- Results publication: PubMed 24727078Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Bjaastad JF, Oeding K, Bjelland I, Silverman WK, Ost LG, Havik OE, Heiervang ER. An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth. Behav Res Ther. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.
- Results publication: PubMed 25637909Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Ost LG, Havik OE, Heiervang ER. Predictors of dropout from community clinic child CBT for anxiety disorders. J Anxiety Disord. 2015 Apr;31:1-10. doi: 10.1016/j.janxdis.2015.01.004. Epub 2015 Jan 22.
- Results publication: PubMed 26583954Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Ost LG, Bjaastad JF, Oeding K, Havik OE, Heiervang ER. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders. Behav Res Ther. 2016 Jan;76:1-12. doi: 10.1016/j.brat.2015.11.001. Epub 2015 Nov 5.
- Derived from this study: PubMed 29195188Kodal A, Fjermestad K, Bjelland I, Gjestad R, Ost LG, Bjaastad JF, Haugland BSM, Havik OE, Heiervang E, Wergeland GJ. Long-term effectiveness of cognitive behavioral therapy for youth with anxiety disorders. J Anxiety Disord. 2018 Jan;53:58-67. doi: 10.1016/j.janxdis.2017.11.003. Epub 2017 Nov 26.
- Derived from this study: PubMed 26647901Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Ost LG, De Los Reyes A, Havik OE, Haugland BS. Therapist-youth agreement on alliance change predicts long-term outcome in CBT for anxiety disorders. J Child Psychol Psychiatry. 2016 May;57(5):625-32. doi: 10.1111/jcpp.12485. Epub 2015 Dec 9.
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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.
Einar Heiervang, MD principal investigator
Haukeland University Hospital
Gro Janne H Wergeland, MD PhD study chair
Haukeland University Hospital
1 site 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 behavioural therapy in people with Separation Anxiety Disorder and Social Anxiety Disorder, run by Haukeland University Hospital 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 1 inclusion and 2 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 8 Aug 2017. 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.
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?
Anxiety disorders according to the ADIS-IV C/P interview (time frame: Post-treatment and 1 and 5 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 NCT00586586, which also lists 5 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 8 Aug 2017.