AnxietyLISTNCT02279251
School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth
A study testing VÅG and CHILLED in people with Anxiety, run by NORCE Norwegian Research Centre AS at 3 sites in Norway.
Trial summary
The study will evaluate two group CBT interventions delivered by school health nurses, in cooperation with community psychologist and mental health care personnel, to adolescents with mild to moderate levels of anxiety symptoms. The two interventions have different intensity (5 versus 10 group meetings). Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Anxiety
- What is being tested?
- VÅG and CHILLED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 3 sitesNorway
- Study dates
- Oct 2013to 1 Nov 2020
- Phase
- Interventional
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- An overall score of > 25 on the anxiety inventory Spence Children's Anxiety Scale (SCAS) and a score of > 1 on the first question of the Children's Anxiety Life Interference Scale (CALIS), indicating that anxiety interferes with daily life of the youth, rated either by the adolescents or by one parent.
- The adolescent and at least one parent understand and read Norwegian.
- Assent from the youth and signed informed consent from the parent.
Who cannot join
- The adolescent has a behavior that makes participation in groups with other adolescents challenging. This is evaluated by the school nurse, based on information from the adolescent, the parent and the teacher. In each case, the school nurse makes an evaluation based on the following questions:
- Is the adolescent able to follow group-rules?
- Will the adolescent behave in ways that disrupts the group?
- Does the adolescent have learning problems to an extent that will make it difficult to follow the group program?
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Municipality of Fjell, Sund and Askoy
Fjell
Sorlandet Hospital HF
Kristiansand
Municipality of Modum
Oslo, East Norway
About this study
Official title: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial
The study will evaluate two group CBT interventions delivered by school health nurses, in cooperation with community psychologist and mental health care personnel, to adolescents with mild to moderate levels of anxiety symptoms. The two interventions have different intensity (5 versus 10 group meetings). The two group interventions will be compared to a waitlist control group.
Read the detailed description
Anxiety disorders are among the major mental health problems in children and adolescents, with regard to prevalence and long-term consequences. Cognitive behavioural therapy (CBT) has proven to be effective as treatment, early intervention and prevention of youth anxiety disorders. The majority of youth with anxiety problems, however, is not in contact with mental health services and do not receive effective help. This is due to shortage of personnel, resources and time among mental health-personal delivering treatment, as well as health services not being easily accessable for adolescents. School-based, low-intensity early intervention programs (indicated prevention) may improve access to effective treatment for youth with internalizing problems, and also promote more effective use of health services. The present study is a multi-site randomized controlled study with early intervention to be conducted within the primary health care service in three parts of Norway; including nine municipalities from west, east and south of Norway. A brief CBT program will be compared to a longer CBT program, and a wait-list control group. The effects will be evaluated with regard to decrease in youth internalizing symptoms. The CBT interventions are given to adolescents with mild to moderate levels of anxiety symptoms. Interventions are delivered by trained school-health nurses in collaboration with and/or supervised by experienced CBT therapists. The study involves researchers from three research environments in Norway, and collaboration with prominent international researchers from USA and Australia.The study has potential impact on how to deliver effective low-threshold interventions to anxious youth.
- Conditions
- Anxiety
- Being tested
- VÅG, CHILLED
- Keywords
- Anxiety, adolescents, school-based, low-intensity CBT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VÅGBehavioural
Low-intensity CBT intervention
CHILLEDBehavioural
Standard length CBT intervention
| Study group | Role | What they receive |
|---|---|---|
| Brief CBT (VÅG) | Active comparator | This is a brief five session CBT group intervention developed at Uni Research. The intervention include self-help material (Psychological First Aid) for the adolescents to use at home between sessions. Receives: Behavioral: VÅG |
| Established CBT program (Cool Kids) | Active comparator | An established, 10 session CBT group program (school version) developed by researchers at Macquarie University, Australia. The intervention has previously not been evaluated with Norwegian adolescents. Receives: Behavioral: CHILLED |
| Waitlist | No intervention | Waiting period is ten weeks, then participants are randomized to one of the two active interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spence Children's Anxiety Scale
Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale.
Measured: Changes from baseline to 4 weeks, 10 weeks, and 1 year
Children Anxiety Life Interference Scale
Self-reported (child and parent version) of degree of life interference of child anxiety symptoms
Measured: Changes from baseline to 4 weeks,10 weeks, and 1 year
Secondary outcomes (4)
Short Mood and Feeling Questionnaire
Questionnaire measuring symptoms of depression (child and parent version)
Measured: Changes from baseline to 4 weeks,10 weeks,and 1 year
Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)
Questionnaire (child and parents version) measuring quality of life in youth
Measured: Changes from baseline to 10 weeks, and 1 year
Clinical Global Impression Scale, severity/improvement (CGI-S/I)
The clinician's (i.e. the school health nurse) global assessment of level of youth anxiety
Measured: Changes from baseline to 10 weeks, and 1 year
Sleep problems
Questionnaire (youth) on variables related to sleep (sleep duration, insomnia etc.)
Measured: Changes from baseline, up to 10 weeks, and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2018
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Modum Bad, Sorlandet Hospital HF
- Responsible party
- Sponsor
- Investigators
- Bente Storm Mowatt Haugland, PhD, Principal investigator, Uni Research Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279251
- Sponsor's protocol ID
- 229020
- Acronym
- LIST
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2014
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haugland BSM, Haaland AT, Baste V, Bjaastad JF, Hoffart A, Rapee RM, Raknes S, Himle JA, Husabo E, Wergeland GJ. Effectiveness of Brief and Standard School-Based Cognitive-Behavioral Interventions for Adolescents With Anxiety: A Randomized Noninferiority Study. J Am Acad Child Adolesc Psychiatry. 2020 Apr;59(4):552-564.e2. doi: 10.1016/j.jaac.2019.12.003. Epub 2020 Jan 8.
PubMed 31926224Haugland BS, Raknes S, Haaland AT, Wergeland GJ, Bjaastad JF, Baste V, Himle J, Rapee R, Hoffart A. School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial. Trials. 2017 Mar 4;18(1):100. doi: 10.1186/s13063-017-1831-9.
PubMed 28259171Haugland BSM, Hysing M, Baste V, Wergeland GJ, Rapee RM, Hoffart A, Haaland AT, Bjaastad JF. Sleep Duration and Insomnia in Adolescents Seeking Treatment for Anxiety in Primary Health Care. Front Psychol. 2021 Mar 24;12:638879. doi: 10.3389/fpsyg.2021.638879. eCollection 2021.
PubMed 33841272Haugland BSM, Hysing M, Hoffart A, Haaland AT, Bjaastad JF, Wergeland GJ, Baste V. Effect of early intervention for anxiety on sleep outcomes in adolescents: a randomized trial. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1-15. doi: 10.1007/s00787-021-01795-6. Epub 2021 May 7.
PubMed 33961115
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02279251
- Acronym / sponsor ID
- LIST / 229020
- Conditions
- Anxiety
- Keywords
- Anxiety, adolescents, school-based, low-intensity CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Modum Bad, Sorlandet Hospital HF
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 31 Oct 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 study will evaluate two group CBT interventions delivered by school health nurses, in cooperation with community psychologist and mental health care personnel, to adolescents with mild to moderate levels of anxiety symptoms. The two interventions have different intensity (5 versus 10 group meetings). The two group interventions will be compared to a waitlist control group.
Detailed description
Anxiety disorders are among the major mental health problems in children and adolescents, with regard to prevalence and long-term consequences. Cognitive behavioural therapy (CBT) has proven to be effective as treatment, early intervention and prevention of youth anxiety disorders. The majority of youth with anxiety problems, however, is not in contact with mental health services and do not receive effective help. This is due to shortage of personnel, resources and time among mental health-personal delivering treatment, as well as health services not being easily accessable for adolescents. School-based, low-intensity early intervention programs (indicated prevention) may improve access to effective treatment for youth with internalizing problems, and also promote more effective use of health services. The present study is a multi-site randomized controlled study with early intervention to be conducted within the primary health care service in three parts of Norway; including nine municipalities from west, east and south of Norway. A brief CBT program will be compared to a longer CBT program, and a wait-list control group. The effects will be evaluated with regard to decrease in youth internalizing symptoms. The CBT interventions are given to adolescents with mild to moderate levels of anxiety symptoms. Interventions are delivered by trained school-health nurses in collaboration with and/or supervised by experienced CBT therapists. The study involves researchers from three research environments in Norway, and collaboration with prominent international researchers from USA and Australia.The study has potential impact on how to deliver effective low-threshold interventions to anxious youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief CBT (VÅG) | Active comparator | Behavioral: VÅGThis is a brief five session CBT group intervention developed at Uni Research. The intervention include self-help material (Psychological First Aid) for the adolescents to use at home between sessions. |
| Established CBT program (Cool Kids) | Active comparator | Behavioral: CHILLEDAn established, 10 session CBT group program (school version) developed by researchers at Macquarie University, Australia. The intervention has previously not been evaluated with Norwegian adolescents. |
| Waitlist | No intervention | –Waiting period is ten weeks, then participants are randomized to one of the two active interventions |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- An overall score of > 25 on the anxiety inventory Spence Children's Anxiety Scale (SCAS) and a score of > 1 on the first question of the Children's Anxiety Life Interference Scale (CALIS), indicating that anxiety interferes with daily life of the youth, rated either by the adolescents or by one parent.
- The adolescent and at least one parent understand and read Norwegian.
- Assent from the youth and signed informed consent from the parent.
Key exclusion criteria (4 listed)
- The adolescent has a behavior that makes participation in groups with other adolescents challenging. This is evaluated by the school nurse, based on information from the adolescent, the parent and the teacher. In each case, the school nurse makes an evaluation based on the following questions:
- Is the adolescent able to follow group-rules?
- Will the adolescent behave in ways that disrupts the group?
- Does the adolescent have learning problems to an extent that will make it difficult to follow the group program?
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 |
|---|---|---|
| VÅGLow-intensity CBT intervention | Behavioural | Brief CBT (VÅG) |
| CHILLEDStandard length CBT intervention | Behavioural | Established CBT program (Cool Kids) |
Primary outcome
Spence Children's Anxiety Scale
Time frame: Changes from baseline to 4 weeks, 10 weeks, and 1 year
Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale.
Children Anxiety Life Interference Scale
Time frame: Changes from baseline to 4 weeks,10 weeks, and 1 year
Self-reported (child and parent version) of degree of life interference of child anxiety symptoms
4 secondary outcomes
Short Mood and Feeling Questionnaire
Time frame: Changes from baseline to 4 weeks,10 weeks,and 1 year
Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)
Time frame: Changes from baseline to 10 weeks, and 1 year
Clinical Global Impression Scale, severity/improvement (CGI-S/I)
Time frame: Changes from baseline to 10 weeks, and 1 year
Sleep problems
Time frame: Changes from baseline, up to 10 weeks, and after 1 year
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 18 Aug 2021.
- Results publication: PubMed 31926224Haugland BSM, Haaland AT, Baste V, Bjaastad JF, Hoffart A, Rapee RM, Raknes S, Himle JA, Husabo E, Wergeland GJ. Effectiveness of Brief and Standard School-Based Cognitive-Behavioral Interventions for Adolescents With Anxiety: A Randomized Noninferiority Study. J Am Acad Child Adolesc Psychiatry. 2020 Apr;59(4):552-564.e2. doi: 10.1016/j.jaac.2019.12.003. Epub 2020 Jan 8.
- Results publication: PubMed 28259171Haugland BS, Raknes S, Haaland AT, Wergeland GJ, Bjaastad JF, Baste V, Himle J, Rapee R, Hoffart A. School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial. Trials. 2017 Mar 4;18(1):100. doi: 10.1186/s13063-017-1831-9.
- Results publication: PubMed 33841272Haugland BSM, Hysing M, Baste V, Wergeland GJ, Rapee RM, Hoffart A, Haaland AT, Bjaastad JF. Sleep Duration and Insomnia in Adolescents Seeking Treatment for Anxiety in Primary Health Care. Front Psychol. 2021 Mar 24;12:638879. doi: 10.3389/fpsyg.2021.638879. eCollection 2021.
- Results publication: PubMed 33961115Haugland BSM, Hysing M, Hoffart A, Haaland AT, Bjaastad JF, Wergeland GJ, Baste V. Effect of early intervention for anxiety on sleep outcomes in adolescents: a randomized trial. Eur Child Adolesc Psychiatry. 2022 Oct;31(10):1-15. doi: 10.1007/s00787-021-01795-6. Epub 2021 May 7.
- 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.
Bente Storm Mowatt Haugland, PhD principal investigator
Uni Research Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VÅG and CHILLED in people with Anxiety, run by NORCE Norwegian Research Centre AS 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 3 inclusion and 4 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 18 Aug 2021. 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.
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?
Spence Children's Anxiety Scale (time frame: Changes from baseline to 4 weeks, 10 weeks, and 1 year). The study lists 2 primary outcomes in all. 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 NCT02279251, which also lists 4 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 18 Aug 2021.