Clinical trial NCT04263558: Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems
Official title: Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: Regionsenter for barn og unges psykiske helse
Sponsor class: OTHER
Collaborators: name: University of Tromso
name: Technical University of Trondheim
First posted: 2020-02-11
Enrollment: 1364
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study will have a stratified, randomized cluster design. The schools are clusters randomized to different experimental conditions. The factors are (1) feedback from a MFS-system, yes/no, (2) Evidence Based Intervention, long/short (EBI), and (3) parental involvement, high/low. The three factors are related components that, together, should form the strongest intervention outcomes. Each of the 40 recruited schools will therefore be randomly assigned to one of eight experimental conditions
Primary purpose: PREVENTION

Brief summary: The present study (Echo) will promote much needed research and innovation that optimize service provision in first line health services for the alarmingly high number of school children who suffer from clinical and subthreshold levels of anxiety and depression. The effect of different versions of an evidence-based intervention for this group of children will be tested using a cluster randomized design involving 40 schools across Norway. The aim is to create a framework that allows more evidence-based psychosocial interventions to be provided at a lower cost to society. Echo will provide knowledge about three main evidence gaps for children: (1) The effect of school-based preventive interventions on anxiety and depression; (2) The effect of feedback informed systems, and; (3) the effect and cost-effectiveness of digital health interventions using online sessions and virtual reality technology.


Eligibility criteria: Inclusion Criteria:

• Children scoring one standard deviation or more above population mean using established measures for anxiety and/or depression

Exclusion Criteria:

* Retardation or language problems
* Developmental conditions
* Individual considerations approved by the local PI

Primary outcomes:
measure: Multidimensional Anxiety Scale
timeFrame: Time 1 baseline
measure: Multidimensional Anxiety Scale
timeFrame: Time 2 after approximal 10 weeks
measure: Multidimensional Anxiety Scale
timeFrame: Time 3 after approximal 1 year
measure: Mood and Feeling Questionnaire
timeFrame: Time 1 baseline
measure: Mood and Feeling Questionnaire
timeFrame: Time 2 after approximal 10 weeks
measure: Mood and Feeling Questionnaire
timeFrame: Time 3 after approximal one year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Regionsenter for barn og unges psykiske helse
city: Tromsø
country: Norway
facility: Regional kunnskapssenter for barn og unge - Nord
city: Trondheim
country: Norway
facility: Regional kunnskapssenter for barn og unge - Midt
Study officials:
affiliation: Center for Child and Adolescent Mental Health
name: Simon-Peter Neumer, Phd
role: PRINCIPAL_INVESTIGATOR
References: