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

November 28, 2023 updated by: Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0484
        • Regionsenter for barn og unges psykiske helse
      • Tromsø, Norway, 9037
        • Regional kunnskapssenter for barn og unge - Nord
      • Trondheim, Norway, 7491
        • Regional kunnskapssenter for barn og unge - Midt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LHF
Long intervention (16 sessions) High parental involvement (5 sessions) Feedback
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: LHN
Long intervention (16 sessions) High parental involvement (5 sessions)
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: LLF
Long intervention (16 sessions) Low parental involvement (Brochure) Feedback
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: LLN
Long intervention (16 sessions) Low parental involvement (Brochure)
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: SHF
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: SHN
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: SLF
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent
Active Comparator: SLN
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)
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).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionsenter for barn og unges psykiske helse

Collaborators

University of Tromso
Technical University of Trondheim

Investigators

  • Principal Investigator: Simon-Peter Neumer, Phd, Center for Child and Adolescent Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 25, 2023

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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