Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems

Anxiety Depression Clinical Trial

Official title:

Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263558
• Other study ID #: 31/18
• Status: Completed
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: May 25, 2023

Study information

• Verified date: November 2023
• Source: Regionsenter for barn og unges psykiske helse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1364
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• Depression

Intervention

Behavioral:
• Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).

Locations

Country	Name	City	State
Norway	Regionsenter for barn og unges psykiske helse	Oslo
Norway	Regional kunnskapssenter for barn og unge - Nord	Tromsø
Norway	Regional kunnskapssenter for barn og unge - Midt	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Regionsenter for barn og unges psykiske helse	Technical University of Trondheim, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Anxiety Scale	Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome	Time 1 baseline
Primary	Multidimensional Anxiety Scale	Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome	Time 2 after approximal 10 weeks
Primary	Multidimensional Anxiety Scale	Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome	Time 3 after approximal 1 year
Primary	Mood and Feeling Questionnaire	Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome	Time 1 baseline
Primary	Mood and Feeling Questionnaire	Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome	Time 2 after approximal 10 weeks
Primary	Mood and Feeling Questionnaire	Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome	Time 3 after approximal one year