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

University of Turku1 site in 1 country465 target enrollmentOctober 24, 2017

ConditionsAnxiety

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: University of Turku
Enrollment: 465
Locations: 1
Primary Endpoint: Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 24, 2017

End Date

December 15, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Turku

Responsible Party

Principal Investigator

Andre Sourander

Professor (child psychiatry)

University of Turku

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports

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

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)

Secondary Outcomes

Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports(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(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(Change from baseline to 6 months follow up; symptoms during the last two weeks)
Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)(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(Change from baseline to 6 months follow up; service use during the last six months)
Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports(Change from baseline to 6 months follow up; impact of anxiety during the last month)
Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report(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)(Change from baseline to 6 months follow up)
Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)(Change from baseline to 6 months follow up; experience of the current resilience)