Clinical trial NCT02279251: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth
Official title: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
adolescents
school-based
low-intensity CBT
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Modum Bad
name: Sorlandet Hospital HF
First posted: 2014-10-31
Enrollment: 313
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. The adolescent and at least one parent understand and read Norwegian.
3. Assent from the youth and signed informed consent from the parent.

Exclusion Criteria:

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:

1. Is the adolescent able to follow group-rules?
2. Will the adolescent behave in ways that disrupts the group?
3. Does the adolescent have learning problems to an extent that will make it difficult to follow the group program?

Primary outcomes:
measure: Spence Children's Anxiety Scale
timeFrame: Changes from baseline to 4 weeks, 10 weeks, and 1 year
measure: Children Anxiety Life Interference Scale
timeFrame: Changes from baseline to 4 weeks,10 weeks, and 1 year
Secondary outcomes:
measure: Short Mood and Feeling Questionnaire
timeFrame: Changes from baseline to 4 weeks,10 weeks,and 1 year
measure: Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)
timeFrame: Changes from baseline to 10 weeks, and 1 year
measure: Clinical Global Impression Scale, severity/improvement (CGI-S/I)
timeFrame: Changes from baseline to 10 weeks, and 1 year
measure: Sleep problems
timeFrame: Changes from baseline, up to 10 weeks, and after 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Municipality of Modum
state: East Norway
city: Fjell
country: Norway
facility: Municipality of Fjell, Sund and Askoy
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
Study officials:
affiliation: Uni Research Health
name: Bente Storm Mowatt Haugland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Haugland 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.
citation: Haugland 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.
citation: Haugland 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.