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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety Depression

Intervention / Treatment
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* Behavioral: Emotion child


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LHF<br>Long intervention (16 sessions) High parental involvement (5 sessions) Feedback | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: LHN<br>Long intervention (16 sessions) High parental involvement (5 sessions) | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: LLF<br>Long intervention (16 sessions) Low parental involvement (Brochure) Feedback | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: LLN<br>Long intervention (16 sessions) Low parental involvement (Brochure) | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: SHF<br>Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: SHN<br>Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: SLF<br>Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|
| Active Comparator: SLN<br>Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) | Behavioral: Emotion child<br>* 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).<br>* Other names: Emotion parent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multidimensional Anxiety Scale | Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome | Time 1 baseline | 
| Multidimensional Anxiety Scale | Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome | Time 2 after approximal 10 weeks | 
| Multidimensional Anxiety Scale | Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome | Time 3 after approximal 1 year | 
| Mood and Feeling Questionnaire | Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome | Time 1 baseline | 
| Mood and Feeling Questionnaire | Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome | Time 2 after approximal 10 weeks | 
| Mood and Feeling Questionnaire | Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome | Time 3 after approximal one year |