School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth (LIST)

August 13, 2021 updated by: NORCE Norwegian Research Centre AS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fjell, Norway
        • Municipality of Fjell, Sund and Askoy
      • Kristiansand, Norway
        • Sorlandet Hospital HF
    • East Norway
      • Oslo, East Norway, Norway
        • Municipality of Modum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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?

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brief CBT (VÅG)
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
Low-intensity CBT intervention
Active Comparator: Established CBT program (Cool Kids)
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
Standard length CBT intervention
No Intervention: Waitlist
Waiting period is ten weeks, then participants are randomized to one of the two active interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes from baseline to 4 weeks, 10 weeks, and 1 year
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
Changes from baseline to 4 weeks,10 weeks, and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Mood and Feeling Questionnaire
Time Frame: Changes from baseline to 4 weeks,10 weeks,and 1 year
Questionnaire measuring symptoms of depression (child and parent version)
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
Questionnaire (child and parents version) measuring quality of life in youth
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
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
Sleep problems
Time Frame: Changes from baseline, up to 10 weeks, and after 1 year
Questionnaire (youth) on variables related to sleep (sleep duration, insomnia etc.)
Changes from baseline, up to 10 weeks, and after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Collaborators

The Research Council of Norway
Sorlandet Hospital HF
Modum Bad

Investigators

  • Principal Investigator: Bente Storm Mowatt Haugland, PhD, Uni Research Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 229020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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