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

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 Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Digitalized cognitive-behavioral intervention for anxiety; Behavioral: Psychoeducation about anxiety

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20500
    • Child Psychiatric Research Center, University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digitalized cognitive-behavioral intervention	Behavioral: Digitalized cognitive-behavioral intervention for anxiety; An internet-based CBT, including telephone coaching
Active Comparator: Psychoeducation about anxiety	Behavioral: Psychoeducation about anxiety; Psychoeducative material about anxiety in internet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Turku

Publications and helpful links

General Publications

• Luntamo T, Korpilahti-Leino T, Ristkari T, Hinkka-Yli-Salomaki S, Kurki M, Sinokki A, Lamminen K, Saanakorpi K, Saarinen S, Maunuksela M, Sourander S, Toivonen K, Zadkova A, Suilamo M, Casagrande L, Palmroth J, Sourander A. Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10-13 years: study protocol for a randomised controlled trial. BMJ Open. 2021 Jun 23;11(6):e045474. doi: 10.1136/bmjopen-2020-045474.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: September 30, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ANXIETY-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No