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Trial record 67 of 991 for:    scale | Norway

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

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date November 12, 2018
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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.
  • 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
  • Clinical Global Impression Scale [ Time Frame: Changes from baseline to 4 weeks, 10 weeks (post-intervention), and 1 year (follow-up) ]
    The clinician's global assessment of level of child anxiety symptoms
Change History Complete list of historical versions of study NCT02279251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • 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)
  • Children Automatic Thought Scale [ Time Frame: Changes from baseline to 10 weeks (post-intervention), and 1 year (follow-up) ]
    Questionnaire measuring thoughts associated with anxiety and depression in youth
  • Strengths and Difficulties Questionnaire [ Time Frame: Changes from baseline to 10 weeks (post-intervention), and 1 year (follow-up) ]
    A brief behavioural screening questionnaire (child and parent version) assessing emotional problems, behavioural problems and prosocial skills.
  • 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
  • Questionnaire measuring ability to solve problems (General Self-Efficacy) [ Time Frame: Changes from baseline to 10 weeks (post-intervention), and 1 year (follow-up) ]
    Questionnaire measuring perceived self-efficacy in youth
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth
Official Title  ICMJE School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth. A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Behavioral: VÅG
    Low-intensity CBT intervention
  • Behavioral: CHILLED
    Evidence based CBT intervention
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: VÅG
  • 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.
    Intervention: Behavioral: CHILLED
  • No Intervention: Waitlist
    Waiting period is ten weeks, then participants are randomized to one of the two active interventions
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 2, 2017)
311
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
393
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02279251
Other Study ID Numbers  ICMJE 229020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NORCE Norwegian Research Centre AS
Study Sponsor  ICMJE NORCE Norwegian Research Centre AS
Collaborators  ICMJE
  • The Research Council of Norway
  • Modum Bad
  • Sorlandet Hospital HF
Investigators  ICMJE
Principal Investigator: Bente Storm Mowatt Haugland, PhD Uni Research Health
PRS Account NORCE Norwegian Research Centre AS
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP