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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Psychoeducation about anxiety; Behavioral: Digitalized cognitive-behavioral intervention for anxiety

• Registration Number: NCT03310489
• Lead Sponsor: University of Turku

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-16
• Study Start: 2017-10-24
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation about anxiety	Psychoeducation about anxiety	-
Digitalized cognitive-behavioral intervention	Digitalized cognitive-behavioral intervention for anxiety	-

Primary Outcome Measures

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

Name	Time	Method
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	A 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 reports	Change from baseline to 6 months follow up; QoL during the last week	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; the Child Depression inventory - child report	Change from baseline to 6 months follow up; symptoms during the last two weeks	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; 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	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; the Customised Client Receipt Inventory Questionnaire - parent report	Change from baseline to 6 months follow up; service use during the last six months	Assesses the child's use of school support services, and social and health care services
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	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; the Strengths and Difficulties Questionnaire, extended version - parent report	Change from baseline to 6 months follow up; symptoms during the last six months	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 of the relations with peers and school (not a standardized scale)	Change from baseline to 6 months follow up	Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers
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	Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)

Trial Locations

Locations (1)

Child Psychiatric Research Center, University of Turku; 🇫🇮 Turku, Finland