School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2020-11-01

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.

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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.

Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

VÅG

Intervention Type BEHAVIORAL

Low-intensity CBT intervention

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.

Group Type ACTIVE_COMPARATOR

CHILLED

Intervention Type BEHAVIORAL

Standard length CBT intervention

Waitlist

Waiting period is ten weeks, then participants are randomized to one of the two active interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VÅG

Low-intensity CBT intervention

Intervention Type BEHAVIORAL

CHILLED

Standard length CBT intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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?

Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No