NCT04263558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 13, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

November 27, 2019

Last Update Submit

November 28, 2023

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (8)

LHF

ACTIVE COMPARATOR

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

Behavioral: Emotion child

LHN

ACTIVE COMPARATOR

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

Behavioral: Emotion child

LLF

ACTIVE COMPARATOR

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

Behavioral: Emotion child

LLN

ACTIVE COMPARATOR

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

Behavioral: Emotion child

SHF

ACTIVE COMPARATOR

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

Behavioral: Emotion child

SHN

ACTIVE COMPARATOR

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

Behavioral: Emotion child

SLF

ACTIVE COMPARATOR

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

Behavioral: Emotion child

SLN

ACTIVE COMPARATOR

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

Behavioral: Emotion child

Interventions

Emotion childBEHAVIORAL

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).

Also known as: Measurement Feedback System (MFS), Emotion parent
LHFLHNLLFLLNSHFSHNSLFSLN

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children scoring one standard deviation or more above population mean using established measures for anxiety and/or depression

You may not qualify if:

  • Retardation or language problems
  • Developmental conditions
  • Individual considerations approved by the local PI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Regionsenter for barn og unges psykiske helse

Oslo, 0484, Norway

Location

Regional kunnskapssenter for barn og unge - Nord

Tromsø, 9037, Norway

Location

Regional kunnskapssenter for barn og unge - Midt

Trondheim, 7491, Norway

Location

Related Publications (5)

  • 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.

    PMID: 41034930DERIVED

  • 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.

    PMID: 39946004DERIVED

  • 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.

    PMID: 38809322DERIVED

  • 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.

    PMID: 38522127DERIVED

  • 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.

    PMID: 38327509DERIVED

Study Officials

  • Simon-Peter Neumer, Phd

    Center for Child and Adolescent Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Phil.

Study Record Dates

First Submitted

November 27, 2019

First Posted

February 11, 2020

Study Start

February 13, 2020

Primary Completion

May 25, 2023

Study Completion

May 25, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)