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

Primary Purpose

Anxiety Depression

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Emotion child
Sponsored by
Regionsenter for barn og unges psykiske helse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Depression

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regionsenter for barn og unges psykiske helse
  • Regional kunnskapssenter for barn og unge - Nord
  • Regional kunnskapssenter for barn og unge - Midt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

LHF

LHN

LLF

LLN

SHF

SHN

SLF

SLN

Arm Description

Long intervention (16 sessions) High parental involvement (5 sessions) Feedback

Long intervention (16 sessions) High parental involvement (5 sessions)

Long intervention (16 sessions) Low parental involvement (Brochure) Feedback

Long intervention (16 sessions) Low parental involvement (Brochure)

Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback

Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)

Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback

Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)

Outcomes

Primary Outcome Measures

Multidimensional Anxiety Scale
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Multidimensional Anxiety Scale
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Multidimensional Anxiety Scale
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Mood and Feeling Questionnaire
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome
Mood and Feeling Questionnaire
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome
Mood and Feeling Questionnaire
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome

Secondary Outcome Measures

Full Information

First Posted
November 27, 2019
Last Updated
April 26, 2023
Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
University of Tromso, Technical University of Trondheim
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1. Study Identification

Unique Protocol Identification Number
NCT04263558
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
University of Tromso, Technical University of Trondheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LHF
Arm Type
Active Comparator
Arm Description
Long intervention (16 sessions) High parental involvement (5 sessions) Feedback
Arm Title
LHN
Arm Type
Active Comparator
Arm Description
Long intervention (16 sessions) High parental involvement (5 sessions)
Arm Title
LLF
Arm Type
Active Comparator
Arm Description
Long intervention (16 sessions) Low parental involvement (Brochure) Feedback
Arm Title
LLN
Arm Type
Active Comparator
Arm Description
Long intervention (16 sessions) Low parental involvement (Brochure)
Arm Title
SHF
Arm Type
Active Comparator
Arm Description
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback
Arm Title
SHN
Arm Type
Active Comparator
Arm Description
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)
Arm Title
SLF
Arm Type
Active Comparator
Arm Description
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback
Arm Title
SLN
Arm Type
Active Comparator
Arm Description
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)
Intervention Type
Behavioral
Intervention Name(s)
Emotion child
Other Intervention Name(s)
Measurement Feedback System (MFS), Emotion parent
Intervention Description
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).
Primary Outcome Measure Information:
Title
Multidimensional Anxiety Scale
Description
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Time Frame
Time 1 baseline
Title
Multidimensional Anxiety Scale
Description
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Time Frame
Time 2 after approximal 10 weeks
Title
Multidimensional Anxiety Scale
Description
Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome
Time Frame
Time 3 after approximal 1 year
Title
Mood and Feeling Questionnaire
Description
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome
Time Frame
Time 1 baseline
Title
Mood and Feeling Questionnaire
Description
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome
Time Frame
Time 2 after approximal 10 weeks
Title
Mood and Feeling Questionnaire
Description
Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome
Time Frame
Time 3 after approximal one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon-Peter Neumer, Phd
Organizational Affiliation
Center for Child and Adolescent Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regionsenter for barn og unges psykiske helse
City
Oslo
ZIP/Postal Code
0484
Country
Norway
Facility Name
Regional kunnskapssenter for barn og unge - Nord
City
Tromsø
ZIP/Postal Code
9037
Country
Norway
Facility Name
Regional kunnskapssenter for barn og unge - Midt
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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