NCT03647826

Brief Summary

The purpose of this study is to strengthen school achievement and positive mental health, and to prevent and reduce school dropout and mental distress among high school students. The researchers will scale up techniques that have already been proven highly effective in preventing common mental disorders (depression, anxiety) in high risk groups (indicated and selective prevention). The researchers will disseminate these techniques to entire first year classes of high school students irrespective of risk factors (universal prevention). The study will report whether universal delivery in school of "Mind Power" - a Cognitive Behaviour Therapy (CBT) based programme - will strengthen school grades, self-efficacy, self-esteem, self-regulation, mental perceptions and well-being, and prevent and reduce school dropout, and symptoms of anxiety and depression. In addition the researchers will analyse whether such universal delivery prevents more mental distress, and is more cost-effective than when it is delivered only to those at high risk for school failure, dropout, or mental distress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,673

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

July 17, 2018

Last Update Submit

March 22, 2023

Conditions

Keywords

youth mental healthmental health preventionempowerment

Outcome Measures

Primary Outcomes (1)

  • Hopkins Symptom Checklist (HSCL-Short form, 8 items)

    Standardized and validated questionnaire: symptoms of anxiety and depression

    2 minutes

Secondary Outcomes (5)

  • Rosenberg Self-Esteem Scale (RSES, short form, 4 items)

    1 minute

  • Lindsley self-regulation (13 items)

    2 minutes

  • The Warwick-Edinburgh Mental Well-being Scale (WEMWBS, 14 items)

    2 minutes

  • The Norwegian Version of the General Perceived Self-Efficacy Scale (short form, 5 items)

    1 minute

  • Reynolds Adolescent Depression Scale, 2nd Ed. Short Form (10 items)

    1 minute

Other Outcomes (2)

  • Students feedback on the experience of attending Mind Power

    2 minutes

  • The seven mental health rights

    4 minutes

Study Arms (2)

Mind Power Intervention Group 1

EXPERIMENTAL

Entire school classes will be randomly divided into two interventions (Mind Power Intervention Group 1 or Mind Power Intervention Group 2). The content in the two interventions are exactly the same, except the time when they are conducted. The first arm is the Mind Power Intervention Group 1. This intervention is the first and starts in September 2018 and last for 10 weeks.

Behavioral: Mind Power Intervention

Mind Power Intervention Group 2

EXPERIMENTAL

The second arm is the Mind Power Intervention Group 2. This arm starts the intervention in January 2019 (six months later than Group 1). Group 2 function as a Control Group. The Experiment containes arm 1 and arm 2; With an delayed intervention design.

Behavioral: Mind Power Intervention

Interventions

The intervention has a total sample of 110 schoool classes, which are devided in two arms: Mind Power Intervention Group 1 or Mind Power Intervention Group 2

Mind Power Intervention Group 1Mind Power Intervention Group 2

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • high Schools have implemented Mind Power in their ordinary scheduals. We include all the students in these school classes, all the classes that the school principals have desided can attend in the study. The Principals choose which classes that will attend in the study, due to the amount of teachers who are able to attend in the project, and due the fixed time scheduals in their ordinary school plan. Then we randomize which of these school classes that starts Mind Power first (Group 1) and which starts six months later (Group 2).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gry Anette Sælid

Oslo, 0403, Norway

Location

Related Publications (1)

  • Saelid GA, Czajkowski NO, Aaro LE, Andersen JR, Idsoe T, Helleseter MD, Holte A. Effects of a school-based intervention on levels of anxiety and depression: a cluster-randomized controlled trial of the MindPower program in ten high schools in Norway. BMC Psychol. 2022 Jan 24;10(1):14. doi: 10.1186/s40359-022-00721-y.

MeSH Terms

Conditions

DepressionStress, PsychologicalEmpowerment

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Gry A Sælid, phd

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Mind Power Intervention Group 1 starts in the beginning of the school semester, and Mind Power Intervention Group 2 functions as a Control Group until it starts six months after Group 1.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 27, 2018

Study Start

September 1, 2018

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations