Behavioural, Emotional, and Psychosocial ProblemsAssertNCT03014596
What Matters to You?
A study testing Assert in people with Behavioural, Emotional, and Psychosocial Problems, run by Regionsenter for barn og unges psykiske helse at 11 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioural, Emotional, and Psychosocial Problems
- What is being tested?
- Assert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesNorway
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial problems
Who cannot join
- severe psychopathological disorders
- severe drug addiction
- intellectual disabilities
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Norway11 sites
Ål kommune
Ål
Ringerike kommune
Hønefoss
Kongsberg kommune
Kongsberg
Skedsmo kommune
Lillestrøm
Lørenskog kommune
Lørenskog
Eidsberg Kommune
Mysen
Bydel Søndre Nordstrand
Oslo
UngArena
Oslo
Familiehuset Adler
Tønsberg
Nome kommune
Ulefoss
Våler kommune
Våler
About this study
Official title: 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.
- Being tested
- Assert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssertOther
The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Assert-method will be used in the counselling of adolescents with mental health problems Receives: Other: Assert |
| Control | No intervention | Treatment as usual, i.e. tha Assert-method will not be used in the counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and difficulties questionnaire (SDQ)
Measured: One year
Inventory of Life Quality in Children and Adolescents (ILC)
Measured: One year
Multidimensional Health Locus of Control (MHLC)
Measured: One year
Secondary outcomes (2)
The Assert measurement tool
An ideographic assessment and monitoring tool, used as a part of the Assert method
Measured: One year
User involvement questionnaire
Perceived degree of user involvement
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioural, Emotional, and Psychosocial ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionsenter for barn og unges psykiske helse
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse
- Investigators
- Turid Suzanne Berg-Nielsen, PhD, Principal investigator, Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014596
- Sponsor's protocol ID
- 2016/FO77493
- Acronym
- Assert
- Status last verified
- Feb 2020
- First submitted
- 4 Jan 2017
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31835096
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Matters to You? How to Strengthen Adolescent User Involvement in Primary Mental Health Services With Systematic Idiographic Assessment
- ClinicalTrials.gov ID
- NCT03014596
- Acronym / sponsor ID
- Assert / 2016/FO77493
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Regionsenter for barn og unges psykiske helseUniversity, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AssertThe Assert-method will be used in the counselling of adolescents with mental health problems |
| Control | No intervention | –Treatment as usual, i.e. tha Assert-method will not be used in the counselling |
Who may qualify
- Ages
- 12 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial problems
Key exclusion criteria (3 listed)
- severe psychopathological disorders
- severe drug addiction
- intellectual disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssertThe Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs. | Other | Intervention |
Primary outcome
Strengths and difficulties questionnaire (SDQ)
Time frame: One year
Inventory of Life Quality in Children and Adolescents (ILC)
Time frame: One year
Multidimensional Health Locus of Control (MHLC)
Time frame: One year
2 secondary outcomes
The Assert measurement tool
Time frame: One year
User involvement questionnaire
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 31835096Tollefsen 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turid Suzanne Berg-Nielsen, PhD principal investigator
Regional Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (RBUP)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assert in people with Behavioural, Emotional, and Psychosocial Problems, run by Regionsenter for barn og unges psykiske helse at 11 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and difficulties questionnaire (SDQ) (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.