School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

NCT02279251 | Completed

• 1 other identifier: 229020
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 3

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.

Conditions

Anxiety

Keywords

Anxiety; adolescents; school-based; low-intensity CBT

Outcome Measures

Primary Outcomes (2)

• Spence Children's Anxiety Scale

  Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale.

  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

  Changes from baseline to 4 weeks,10 weeks, and 1 year

Secondary Outcomes (4)

• Short Mood and Feeling Questionnaire

  Changes from baseline to 4 weeks,10 weeks,and 1 year

• Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)

  Changes from baseline to 10 weeks, and 1 year

• Clinical Global Impression Scale, severity/improvement (CGI-S/I)

  Changes from baseline to 10 weeks, and 1 year

• Sleep problems

  Changes from baseline, up to 10 weeks, and after 1 year

Study Arms (3)

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.

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.

Behavioral: CHILLED

Waitlist

NO INTERVENTION

Waiting period is ten weeks, then participants are randomized to one of the two active interventions

Interventions

VÅG BEHAVIORAL

Low-intensity CBT intervention

Brief CBT (VÅG)

CHILLED BEHAVIORAL

Standard length CBT intervention

Established CBT program (Cool Kids)

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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?

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• The Research Council of Norway: collaborator
• Modum Bad: collaborator
• Sorlandet Hospital HF: collaborator

Study Sites (3)

Municipality of Modum

Oslo, East Norway, Norway

Location

Municipality of Fjell, Sund and Askoy

Fjell, Norway

Location

Sorlandet Hospital HF

Kristiansand, Norway

Location

Related Publications (4)

• 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.

  PMID: 31926224 RESULT

• 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.

  PMID: 28259171 RESULT

• 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.

  PMID: 33841272 RESULT

• 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.

  PMID: 33961115 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Bente Storm Mowatt Haugland, PhD

  Uni Research Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: November 1, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)