NCT03014596

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

January 4, 2017

Last Update Submit

February 7, 2020

Conditions

Behavioural, Emotional, and Psychosocial Problems

Outcome Measures

Primary Outcomes (3)

  • Strengths and difficulties questionnaire (SDQ)

    One year

  • Inventory of Life Quality in Children and Adolescents (ILC)

    One year

  • Multidimensional Health Locus of Control (MHLC)

    One year

Secondary Outcomes (2)

  • The Assert measurement tool

    One year

  • User involvement questionnaire

    One year

Study Arms (2)

Intervention

EXPERIMENTAL

The Assert-method will be used in the counselling of adolescents with mental health problems

Other: Assert

Control

NO INTERVENTION

Treatment as usual, i.e. tha Assert-method will not be used in the counselling

Interventions

AssertOTHER

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

Intervention

Eligibility Criteria

Age12 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • severe psychopathological disorders
  • severe drug addiction
  • intellectual disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ål kommune

Ål, Norway

Location

Ringerike kommune

Hønefoss, Norway

Location

Kongsberg kommune

Kongsberg, Norway

Location

Skedsmo kommune

Lillestrøm, Norway

Location

Lørenskog kommune

Lørenskog, Norway

Location

Eidsberg Kommune

Mysen, Norway

Location

Bydel Søndre Nordstrand

Oslo, Norway

Location

UngArena

Oslo, Norway

Location

Familiehuset Adler

Tønsberg, Norway

Location

Nome kommune

Ulefoss, Norway

Location

Våler kommune

Våler, Norway

Location

Related Publications (1)

  • Tollefsen TK, Neumer SP, Berg-Nielsen TS. "What matters to you?": A randomized controlled effectiveness trial, Using Systematic Idiographic Assessment as an intervention to Increase Adolescents' perceived control of their mental health. J Adolesc. 2020 Jan;78:53-61. doi: 10.1016/j.adolescence.2019.11.006. Epub 2019 Dec 10.

    PMID: 31835096DERIVED

Study Officials

  • Turid Suzanne Berg-Nielsen, PhD

    Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(11)