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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03014596
Other study ID # 2016/FO77493
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date June 2018

Study information

Verified date February 2020
Source Regionsenter for barn og unges psykiske helse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 23 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Behavioural, Emotional, and Psychosocial Problems

Intervention

Other:
Assert
The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.

Locations

Country Name City State
Norway Ål kommune Ål
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

Sponsors (2)

Lead Sponsor Collaborator
Regionsenter for barn og unges psykiske helse Norwegian Extra Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Strengths and difficulties questionnaire (SDQ) One year
Primary Inventory of Life Quality in Children and Adolescents (ILC) One year
Primary Multidimensional Health Locus of Control (MHLC) One year
Secondary The Assert measurement tool An ideographic assessment and monitoring tool, used as a part of the Assert method One year
Secondary User involvement questionnaire Perceived degree of user involvement One year