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

NCT ID: NCT04263558

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2023-05-25

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.

Detailed Description

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Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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LHF

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

LHN

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

LLF

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

LLN

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

SHF

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

SHN

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

SLF

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

SLN

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

Group Type ACTIVE_COMPARATOR

Emotion child

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Measurement Feedback System (MFS) Emotion parent

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tromso

OTHER

Sponsor Role collaborator

Technical University of Trondheim

UNKNOWN

Sponsor Role collaborator

Regionsenter for barn og unges psykiske helse

OTHER

Sponsor Role lead

Responsible Party

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Simon-Peter Neumer

Dr. Phil.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon-Peter Neumer, Phd

Role: PRINCIPAL_INVESTIGATOR

Center for Child and Adolescent Mental Health

Locations

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Regionsenter for barn og unges psykiske helse

Oslo, , Norway

Site Status

Regional kunnskapssenter for barn og unge - Nord

Tromsø, , Norway

Site Status

Regional kunnskapssenter for barn og unge - Midt

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Martinsen KD, Aas E, Ingul JM, Lisoy C, Adolfsen F, Rasmussen LM, Wentzel-Larsen T, Neumer SP. Cost-effectiveness analysis of preventive strategies for child anxiety and depression: a health service perspective. Child Adolesc Psychiatry Ment Health. 2025 Oct 1;19(1):107. doi: 10.1186/s13034-025-00962-w.

Reference Type DERIVED
PMID: 41034930 (View on PubMed)

Ytreland K, Bania EV, Lydersen S, Sund AM, Neumer SP, Adolfsen F, Martinsen KD, Rasmussen LP, Ingul JM. Parental Involvement in Child Anxiety and Depression: Exploring the Impact of Delivery Format on Modifiable Parental Factors. Child Psychiatry Hum Dev. 2025 Feb 13. doi: 10.1007/s10578-025-01814-6. Online ahead of print.

Reference Type DERIVED
PMID: 39946004 (View on PubMed)

Haug IM, Neumer SP, Handegard BH, Lisoy C, Rasmussen LP, Bania EV, Adolfsen F, Patras J. Dose-Response Effects of MittEcho, a Measurement Feedback System, in an Indicated Mental Health Intervention for Children in Municipal and School Services in Norway. Adm Policy Ment Health. 2025 Jan;52(1):223-240. doi: 10.1007/s10488-024-01389-9. Epub 2024 May 29.

Reference Type DERIVED
PMID: 38809322 (View on PubMed)

Lisoy C, Neumer SP, Adolfsen F, Ingul JM, Potulski Rasmussen LM, Wentzel-Larsen T, Patras J, Sund AM, Ytreland K, Waaktaar T, Holen S, Askeland AL, Haug IM, Bania EV, Martinsen K. Optimizing indicated cognitive behavioral therapy to prevent child anxiety and depression: A cluster-randomized factorial trial. Behav Res Ther. 2024 May;176:104520. doi: 10.1016/j.brat.2024.104520. Epub 2024 Mar 18.

Reference Type DERIVED
PMID: 38522127 (View on PubMed)

Martinsen K, Lisoy C, Wentzel-Larsen T, Neumer SP, Rasmussen LP, Adolfsen F, Sund AM, Ingul JM. School children's mental health during the COVID-19 pandemic. Front Psychol. 2024 Jan 5;14:1290358. doi: 10.3389/fpsyg.2023.1290358. eCollection 2023.

Reference Type DERIVED
PMID: 38327509 (View on PubMed)

Other Identifiers

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31/18

Identifier Type: -

Identifier Source: org_study_id