School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

Anxiety Clinical Trial

— LIST  

Official title:

School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02279251
• Other study ID #: 229020
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: November 1, 2020

Study information

• Verified date: August 2021
• Source: NORCE Norwegian Research Centre AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The two group interventions will be compared to a waitlist control group.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: November 1, 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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?

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• VÅG
Low-intensity CBT intervention
• CHILLED
Standard length CBT intervention

Locations

Country	Name	City	State
Norway	Municipality of Fjell, Sund and Askoy	Fjell
Norway	Sorlandet Hospital HF	Kristiansand
Norway	Municipality of Modum	Oslo	East Norway

Sponsors (4)

Lead Sponsor	Collaborator
NORCE Norwegian Research Centre AS	Modum Bad, Sorlandet Hospital HF, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View Citation

Haugland BSM, Haaland ÅT, Baste V, Bjaastad JF, Hoffart A, Rapee RM, Raknes S, Himle JA, Husabø E, Wergeland GJ. Effectiveness of Brief and Standard School-Based Cognitive-Behavioral Interventions for Adolescents With Anxiety: A Randomized Noninferiority — View Citation

Haugland BSM, Hysing M, Baste V, Wergeland GJ, Rapee RM, Hoffart A, Haaland ÅT, 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.2021.638 — View Citation

Haugland BSM, Hysing M, Hoffart A, Haaland ÅT, Bjaastad JF, Wergeland GJ, Baste V. Effect of early intervention for anxiety on sleep outcomes in adolescents: a randomized trial. Eur Child Adolesc Psychiatry. 2021 May 7. doi: 10.1007/s00787-021-01795-6. [E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Short Mood and Feeling Questionnaire	Questionnaire measuring symptoms of depression (child and parent version)	Changes from baseline to 4 weeks,10 weeks,and 1 year
Secondary	Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)	Questionnaire (child and parents version) measuring quality of life in youth	Changes from baseline to 10 weeks, and 1 year
Secondary	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	Changes from baseline to 10 weeks, and 1 year
Secondary	Sleep problems	Questionnaire (youth) on variables related to sleep (sleep duration, insomnia etc.)	Changes from baseline, up to 10 weeks, and after 1 year