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Mind Power - A CBT Based Program for Adolescents

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ClinicalTrials.gov Identifier: NCT03647826
Recruitment Status : Enrolling by invitation
First Posted : August 27, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Norwegian Institute of Public Health

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.

Condition or disease Intervention/treatment Phase
Mental Depression Mental Stress Mental Health Wellness 1 Behavioral: Mind Power Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mind Power - A CBT Based Program for Adolescents Aimed at Developing Coping Skills
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 10, 2020
Estimated Study Completion Date : June 10, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Mind Power Intervention Group 1

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
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

Experimental: Mind Power Intervention Group 2

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
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




Primary Outcome Measures :
  1. Hopkins Symptom Checklist (HSCL-Short form, 8 items) [ Time Frame: 2 minutes ]
    Standardized and validated questionnaire: symptoms of anxiety and depression


Secondary Outcome Measures :
  1. Rosenberg Self-Esteem Scale (RSES, short form, 4 items) [ Time Frame: 1 minute ]
    Standaardized and validated: Self-Esteem

  2. Lindsley self-regulation (13 items) [ Time Frame: 2 minutes ]
    Standardized and validated: Self-Regulation

  3. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS, 14 items) [ Time Frame: 2 minutes ]
    Standardized and validated: Mental well-being scale

  4. The Norwegian Version of the General Perceived Self-Efficacy Scale (short form, 5 items) [ Time Frame: 1 minute ]
    Standardized and validated: Self-Efficacy

  5. Reynolds Adolescent Depression Scale, 2nd Ed. Short Form (10 items) [ Time Frame: 1 minute ]
    Standardized and validated: Depression


Other Outcome Measures:
  1. Students feedback on the experience of attending Mind Power [ Time Frame: 2 minutes ]
    Evaluation form: with questions regarding the young people's experience of the programme in their local context.

  2. The seven mental health rights [ Time Frame: 4 minutes ]
    24 questions rearding the students belifs about the meening of life



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 10 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).

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647826


Locations
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Norway
Gry Anette Sælid
Oslo, Norway, 0403
Sponsors and Collaborators
Norwegian Institute of Public Health
Investigators
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Principal Investigator: Gry A Sælid, phd Norwegian Institute of Public Health

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Responsible Party: Norwegian Institute of Public Health
ClinicalTrials.gov Identifier: NCT03647826     History of Changes
Other Study ID Numbers: 2510
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Services of sensitiv data (TSD) at the University of Oslo is providing this option.

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

Keywords provided by Norwegian Institute of Public Health:
youth mental health
mental health prevention
empowerment

Additional relevant MeSH terms:
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Depression
Stress, Psychological
Behavioral Symptoms