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What Matters to You? (Assert)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014596
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Norwegian Extra Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse

Brief Summary:

Procedures for systematic user involvement in primary mental health services are lacking, and several adolescents are dissatisfied with their opportunities to influence the service provided. The research on the effects of user involvement is scarce, especially regarding user involvement for children and adolescents. Hence, we suggest introducing an idiographic assessment tool in a selection of Norwegian primary mental health services. Idiographic assessment is a way of measuring psychological constructs, by using tools specifically adapted for each individual respondent.

This protocol describes the implementation and evaluation of a user involvement tool called 'Assert', in Norwegian primary mental health services. Assert is a simple tool where the adolescents themselves decide the goals or themes that they would like to address in collaboration with their service provider. Assert is scored each time the adolescent and the service provider meet, to monitor progress toward the goal. A randomised controlled trial design is proposed for this study. Assert will be implemented in 5-10 Norwegian municipalities, and will include 250 participants between 12 and 23 years. The objective of the study is to examine the relationship between Assert and perceived user involvement. Are idiographic measures an adequate way to operationalise user involvement on an individual level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and goals will be conducted to explore what matters to the adolescents that visit primary mental health services in Norwegian municipalities.


Condition or disease Intervention/treatment Phase
Behavioural, Emotional, and Psychosocial Problems Other: Assert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: What Matters to You? How to Strengthen Adolescent User Involvement in Primary Mental Health Services With Systematic Idiographic Assessment
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Intervention
The Assert-method will be used in the counselling of adolescents with mental health problems
Other: Assert
The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.

No Intervention: Control
Treatment as usual, i.e. tha Assert-method will not be used in the counselling



Primary Outcome Measures :
  1. Strengths and difficulties questionnaire (SDQ) [ Time Frame: One year ]
  2. Inventory of Life Quality in Children and Adolescents (ILC) [ Time Frame: One year ]
  3. Multidimensional Health Locus of Control (MHLC) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. The Assert measurement tool [ Time Frame: One year ]
    An ideographic assessment and monitoring tool, used as a part of the Assert method

  2. User involvement questionnaire [ Time Frame: One year ]
    Perceived degree of user involvement



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial problems

Exclusion Criteria:

  • severe psychopathological disorders
  • severe drug addiction
  • intellectual disabilities

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): NCT03014596


Locations
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Norway
Ringerike kommune
Hønefoss, Norway
Kongsberg kommune
Kongsberg, Norway
Skedsmo kommune
Lillestrøm, Norway
Lørenskog kommune
Lørenskog, Norway
Eidsberg Kommune
Mysen, Norway
Bydel Søndre Nordstrand
Oslo, Norway
UngArena
Oslo, Norway
Familiehuset Adler
Tønsberg, Norway
Nome kommune
Ulefoss, Norway
Våler kommune
Våler, Norway
Ål kommune
Ål, Norway
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
Norwegian Extra Foundation for Health and Rehabilitation
Investigators
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Principal Investigator: Turid Suzanne Berg-Nielsen, PhD Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon-Peter Neumer, PhD, Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT03014596    
Other Study ID Numbers: 2016/FO77493
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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