A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.

Official Title
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Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Digitalized cognitive-behavioral intervention for anxiety
* Behavioral: Psychoeducation about anxiety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Scoring ≥22 on SCARED Exclusion Criteria: no access to internet insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills visual or hearing impairment that hinders the use of the program the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder the child's psychotherapy (ongoing or starting within 6 months) the child's medication (for anxiety) started / changed within 2 months current involvement with child protection services (i.e., removal of child custody, investigation of child abuse or neglect) parent's severe psychiatric / somatic disease or other reason that hinders the parent to actively participate in the program
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digitalized cognitive-behavioral intervention<br> | Behavioral: Digitalized cognitive-behavioral intervention for anxiety<br>* An internet-based CBT, including telephone coaching<br>|
| Active Comparator: Psychoeducation about anxiety<br> | Behavioral: Psychoeducation about anxiety<br>* Psychoeducative material about anxiety in internet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports | Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms) | Change from baseline to 6 months follow up; symptoms during the last three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports | Comprises of 27 items assessing the impact of anxiety on the daily life of the children at home, school and with friends; scoring 0-81 (higher score meaning higher impact of anxiety) | Change from baseline to 6 months follow up; impact of anxiety during the last month | 
| Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports | A diagnostic interview to assess anxiety disorders among 2-17-year-old children | Change from baseline to 6 months follow up; varying time windows for different diagnoses | 
| Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports | Comprises of 24 items assessing the health-related quality of life divided into six subscales: physical, psychological, self-esteem, family, social life, and school; scoring 24-96 (higher score meaning higher QoL) | Change from baseline to 6 months follow up; QoL during the last week | 
| Change from Baseline to 6 months follow up; the Child Depression inventory - child report | Comprises of 28 items assessing the child's depressive symptoms; scoring 0-54 (higher score meaning more symptoms) | Change from baseline to 6 months follow up; symptoms during the last two weeks | 
| Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report | Comprises of 25 items assessing the child's psychiatric symptoms and positive attributes, and an impact supplement; scoring 0-40 (prosocial scale is not included in the total score) (higher score meaning more problems) | Change from baseline to 6 months follow up; symptoms during the last six months | 
| Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale) | Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers | Change from baseline to 6 months follow up | 
| Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience) | Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience) | Change from baseline to 6 months follow up; experience of the current resilience | 
| Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress) | Comprises of 21 items assessing parental depression, anxiety and stress; scoring 0-63 (higher score meaning more symptoms) | Change from baseline to 6 months follow up; symptoms during the last week | 
| Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report | Assesses the child's use of school support services, and social and health care services | Change from baseline to 6 months follow up; service use during the last six months |