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

University of Turku465 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

465

Conditions

Anxiety

Interventions

Digitalized cognitive-behavioral intervention for anxietyBEHAVIORAL

An internet-based CBT, including telephone coaching

Psychoeducation about anxietyBEHAVIORAL

Psychoeducative material about anxiety in internet

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Child Psychiatric Research Center, University of Turku

Turku, Finland

Outcomes

Primary Outcomes

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)

Time frame: Change from baseline to 6 months follow up; symptoms during the last three months

Secondary Outcomes

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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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