School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: VÅG; Behavioral: CHILLED

• Registration Number: NCT02279251
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-31
• Primary Completion: 2018-07
• Study Completion: 2020-11-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief CBT (VÅG)	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.
Established CBT program (Cool Kids)	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.

Primary Outcome Measures

Name	Time	Method
Spence Children's Anxiety Scale	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.
Children Anxiety Life Interference Scale	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 Outcome Measures

Name	Time	Method
Questionnaire for Measuring Health-Related Quality of Life Children and Adolescents (KINDL-R)	Changes from baseline to 10 weeks, and 1 year	Questionnaire (child and parents version) measuring quality of life in youth
Short Mood and Feeling Questionnaire	Changes from baseline to 4 weeks,10 weeks,and 1 year	Questionnaire measuring symptoms of depression (child and parent version)
Clinical Global Impression Scale, severity/improvement (CGI-S/I)	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
Sleep problems	Changes from baseline, up to 10 weeks, and after 1 year	Questionnaire (youth) on variables related to sleep (sleep duration, insomnia etc.)

Trial Locations

Locations (3)

Sorlandet Hospital HF; 🇳🇴 Kristiansand, Norway

Municipality of Fjell, Sund and Askoy; 🇳🇴 Fjell, Norway

Municipality of Modum; 🇳🇴 Oslo, East Norway, Norway