- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014596
What Matters to You? (Assert)
What Matters to You? How to Strengthen Adolescent User Involvement in Primary Mental Health Services With Systematic Idiographic Assessment
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hønefoss, Norway
- Ringerike kommune
-
Kongsberg, Norway
- Kongsberg kommune
-
Lillestrøm, Norway
- Skedsmo kommune
-
Lørenskog, Norway
- Lørenskog kommune
-
Mysen, Norway
- Eidsberg Kommune
-
Oslo, Norway
- Bydel Søndre Nordstrand
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Oslo, Norway
- UngArena
-
Tønsberg, Norway
- Familiehuset Adler
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Ulefoss, Norway
- Nome kommune
-
Våler, Norway
- Våler kommune
-
Ål, Norway
- Ål kommune
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial problems
Exclusion Criteria:
- severe psychopathological disorders
- severe drug addiction
- intellectual disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
The Assert-method will be used in the counselling of adolescents with mental health problems
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Strengths and difficulties questionnaire (SDQ)
Time Frame: One year
|
One year
|
Inventory of Life Quality in Children and Adolescents (ILC)
Time Frame: One year
|
One year
|
Multidimensional Health Locus of Control (MHLC)
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Assert measurement tool
Time Frame: One year
|
An ideographic assessment and monitoring tool, used as a part of the Assert method
|
One year
|
User involvement questionnaire
Time Frame: One year
|
Perceived degree of user involvement
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Turid Suzanne Berg-Nielsen, PhD, Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016/FO77493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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