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Completed

NCT Number: NCT02279251

School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

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.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Municipality of Modum, Oslo, East Norway, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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:

  • 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?

Treatment and study plan

VÅG

Behavioral

Low-intensity CBT intervention

CHILLED

Behavioral

Standard length CBT intervention

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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.)

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Collaborators

  • Modum Bad
  • Sorlandet Hospital HF
  • The Research Council of Norway

Registry information

Official study title

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

Acronym: LIST

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Oct 31, 2014
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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