Anxiety Clinical Trial
Official title:
Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
Verified date | February 2024 |
Source | University of Turku |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 465 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Child Psychiatric Research Center, University of Turku | Turku |
Lead Sponsor | Collaborator |
---|---|
University of Turku |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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