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

NCT03310489 | Completed

• 1 other identifier: ANXIETY-2017
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 (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 Strengths and Difficulties Questionnaire, extended version - parent report

  Change from baseline to 6 months follow up; symptoms during the last six months

Study Arms (2)

Digitalized cognitive-behavioral intervention

EXPERIMENTAL

Behavioral: Digitalized cognitive-behavioral intervention for anxiety

Psychoeducation about anxiety

ACTIVE COMPARATOR

Behavioral: Psychoeducation about anxiety

Interventions

Digitalized cognitive-behavioral intervention for anxiety BEHAVIORAL

An internet-based CBT, including telephone coaching

Digitalized cognitive-behavioral intervention

Psychoeducation about anxiety BEHAVIORAL

Psychoeducative material about anxiety in internet

Psychoeducation about anxiety

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Scoring ≥22 on SCARED

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Child Psychiatric Research Center, University of Turku

Turku, 20500, Finland

Location

Related Publications (2)

• Sourander A, Korpilahti-Leino T, Kaajalaakso K, Ristkari T, Hinkka-Yli-Salomaki S, Stahlberg T, Luntamo T. Internet-Based Cognitive-Behavioral Therapy Intervention Master Your Worries With Telephone Coaching for Anxious Finnish Children Aged 10-13 Years: A Population-Based Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Nov;64(11):1281-1294. doi: 10.1016/j.jaac.2024.11.024. Epub 2025 Feb 4.

  PMID: 39914585 DERIVED

• 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.

  PMID: 34162641 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (child psychiatry)

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 16, 2017
• Study Start: October 24, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FI (1)