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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03310489
Enrollment
465
Registered
2017-10-16
Start date
2017-10-24
Completion date
2020-12-15
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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.

Interventions

BEHAVIORALDigitalized cognitive-behavioral intervention for anxiety

An internet-based CBT, including telephone coaching

BEHAVIORALPsychoeducation about anxiety

Psychoeducative material about anxiety in internet

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reportsChange from baseline to 6 months follow up; symptoms during the last three monthsComprises 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

MeasureTime frameDescription
Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reportsChange from baseline to 6 months follow up; varying time windows for different diagnosesA diagnostic interview to assess anxiety disorders among 2-17-year-old children
Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reportsChange from baseline to 6 months follow up; QoL during the last weekComprises 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; the Child Depression inventory - child reportChange from baseline to 6 months follow up; symptoms during the last two weeksComprises 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; the Strengths and Difficulties Questionnaire, extended version - parent reportChange from baseline to 6 months follow up; symptoms during the last six monthsComprises 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; the Child Anxiety Impact Scale - child and parent reportsChange from baseline to 6 months follow up; impact of anxiety during the last monthComprises 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; the Brief resilience scale - parent report (parental resilience)Change from baseline to 6 months follow up; experience of the current resilienceComprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)
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 weekComprises 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; the Customised Client Receipt Inventory Questionnaire - parent reportChange from baseline to 6 months follow up; service use during the last six monthsAssesses the child's use of school support services, and social and health care services
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 upExperience of being bullied (traditional and cyberbullying), and feelings about school and teachers

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026