Clinical trial NCT03310489: A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
Official title: Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 465
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
timeFrame: Change from baseline to 6 months follow up; symptoms during the last three months
Secondary outcomes:
measure: Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports
timeFrame: Change from baseline to 6 months follow up; impact of anxiety during the last month
measure: Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports
timeFrame: Change from baseline to 6 months follow up; varying time windows for different diagnoses
measure: Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports
timeFrame: Change from baseline to 6 months follow up; QoL during the last week
measure: Change from Baseline to 6 months follow up; the Child Depression inventory - child report
timeFrame: Change from baseline to 6 months follow up; symptoms during the last two weeks
measure: Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report
timeFrame: Change from baseline to 6 months follow up; symptoms during the last six months
measure: Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)
timeFrame: Change from baseline to 6 months follow up
measure: Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)
timeFrame: Change from baseline to 6 months follow up; experience of the current resilience
measure: Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)
timeFrame: Change from baseline to 6 months follow up; symptoms during the last week
measure: Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report
timeFrame: Change from baseline to 6 months follow up; service use during the last six months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Child Psychiatric Research Center, University of Turku
Study officials:
References:
citation: 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.