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

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ClinicalTrials.gov Identifier: NCT02279251
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : November 12, 2018
Sponsor:
Collaborators:
The Research Council of Norway
Modum Bad
Sorlandet Hospital HF
Information provided by (Responsible Party):
NORCE Norwegian Research Centre AS

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: VÅG Behavioral: CHILLED Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 (CHILLED)
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
Evidence based CBT intervention

No Intervention: Waitlist
Waiting period is ten weeks, then participants are randomized to one of the two active interventions



Primary Outcome Measures :
  1. Spence Children's Anxiety Scale [ Time Frame: Changes from baseline to 4 weeks, 10 weeks (post-intervention), and 1 year (follow-up) ]
    Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale.

  2. Children Anxiety Life Interference Scale [ Time Frame: Changes from baseline to 4 weeks, 10 weeks (post-intervention), and 1 year (follow-up) ]
    Self-reported (child and parent version) of degree of life interference of child anxiety symptoms


Secondary Outcome Measures :
  1. Short Mood and Feeling Questionnaire [ Time Frame: Changes from baseline to 10 weeks (post-intervention), and 1 year (follow-up) ]
    Questionnaire measuring symptoms of depression (child and parent version)

  2. Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL-R) [ Time Frame: Changes from baseline to 10 weeks (post-intervention), and 1 year (follow-up) ]
    Questionnaire (child and parents version) measuring quality of life in youth

  3. Clinical Global Impression Scale, severity/improvement (CGI-S/I) [ Time Frame: Changes from baseline to 4 weeks, 10 weeks (post-intervention), and 1 year (follow-up) ]
    The clinician's (i.e. the school health nurse) global assessment of level of youth anxiety



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279251


Locations
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Norway
Municipality of Modum
Oslo, East Norway, Norway
Municipality of Fjell, Sund and Askoy
Fjell, Norway
Soerlandet Hospital HF
Kristiansand, Norway
Sponsors and Collaborators
NORCE Norwegian Research Centre AS
The Research Council of Norway
Modum Bad
Sorlandet Hospital HF
Investigators
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Principal Investigator: Bente Storm Mowatt Haugland, PhD Uni Research Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NORCE Norwegian Research Centre AS
ClinicalTrials.gov Identifier: NCT02279251     History of Changes
Other Study ID Numbers: 229020
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2017
Keywords provided by NORCE Norwegian Research Centre AS:
Anxiety
adolescents
school-based
low-intensity CBT