School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: VÅG
* Behavioral: CHILLED


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Sleep problems | Questionnaire (youth) on variables related to sleep (sleep duration, insomnia etc.) | Changes from baseline, up to 10 weeks, and after 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, adolescents, school-based, low-intensity CBT