Mental Health CareMAPNCT06886165
My Avenue to helP - Adaptive Mentalization-based Integrative Treatment Compared to Management as Usual for Youths With Multiple Problems: a Non-Randomized Controlled Feasibility Trial
A study testing My Avenue to HelP and Management as Usual in people with Mental Health Care and AMBIT, run by Pia Jeppesen at 1 site in Denmark.
Trial summary
My Avenue to HelP (MAP) is a non-randomized feasibility study testing the implementation of a cross-sectoral collaboration targeted youths, aged 12-17 years, with multiple social and psychological problems. MAP is a one-year intervention based on Adaptive Mentalization-Based Integrative Treatment (AMBIT). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health Care, AMBIT, Adaptive Mentalization-Based Integrative Treatment
- What is being tested?
- My Avenue to HelP and Management as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2025to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Criterium A) Documented record of multiple problems defined as at least 2 of the following: (i) Absence from school / non-adherence to education (ii) Risk behaviors like alcohol or cannabis abuse, or repeated suicide attempts or self-harm requiring somatic treatment.(iii) Repeated visits at emergency-, trauma-, or acute wards. And/or one of the following: (iv) Contact with police or legal justice system. (v) Homelessness within the last year.
- Criterium B) Age 12-17 years at time of inclusion.
- Criterium C) Strong indication of mental disorders defined as a diagnosis of a mental disorder. The type of mental disorders will be further substantiated using the DAWBA after recruitment (Goodman et al., 2000).
- Criterium D) Written/signed informed consent from all legal guardians (in most cases both parents) and oral consent from youths aged 15 years and older. Written/signed informed consent from the youths themselves will be collected when they turn 18 if they do so during the study period.
Who cannot join
- Indications of substantial intellectual disability corresponding to IQ below 50, or a level of daily and social functions that do not enable participation in research (e.g., if the young person is not deemed to have the capacity to understand the implications of the study and provide oral consent).
- Not living in Region Zealand.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Child and Adolescent Psychiatric Department, Psychiatry Region Zealand
Roskilde, Region Sjælland, 4000
Pia Jeppesen, Professor, Ph.d., 23969929, pijep@regionsjaelland.dk
Kristine Hansen, MD, +4553639199, ktrh@regsj.dk
About this study
My Avenue to HelP (MAP) is a non-randomized feasibility study testing the implementation of a cross-sectoral collaboration targeted youths, aged 12-17 years, with multiple social and psychological problems. MAP is a one-year intervention based on Adaptive Mentalization-Based Integrative Treatment (AMBIT). MAP is not a new treatment method, but rather a new way of offering and organizing support in the existing network around the young person. The objective is to create a new way for professionals across sectors to collaborate in supporting our most vulnerable youth. Thereby, the investigators aim to benefit the youths by incorporating a mentalizing stance to promote lasting changes beyond the intervention period. The MAP Project will run from 2025 to 2027.
The research will consist of two work packages (WPs)
Read more
- WP1 will test the feasibility of the MAP project examining a) whether young people can be successfully recruited to the project b) if the evaluation design and methods are feasible and c) if the intervention is feasible to participants and employees (quantitatively).
- WP2 will assess implementation determinants and evaluate the implementation strategies employed in the project. Furthermore, the acceptability of the intervention will qualitatively be assessed by interviews with selected participants, their parents, as well as employees.
Participants:
In total 60 youths aged 12-17 years from Region Zealand, Denmark:
- 40 youths will be enrolled and receive the one-year MAP Intervention; 30 youths residing in Roskilde Municipality and 10 residing in Lejre Municipality
- 20 youths from other municipalities in Region Zealand will be included in the trial as a control group.
To assess the nature and extent of the mental health problems and potential psychiatric disorders among the participating youths, the parents and the young person will be asked to complete an online questionnaire (Development and Well-Being Assessment (DAWBA)).
- Conditions
- Mental Health Care, AMBIT, Adaptive Mentalization-Based Integrative Treatment, Child and Adolescent Psychiatry, Health Care Professionals, Mental Health Services
- Being tested
- My Avenue to HelP, Management as Usual
- Keywords
- AMBIT, Adative Mentalization-Based Integrative Treatment, Child and Adolescent Psychiatry, Cross-sectoral Collaboration, Interdisiplinary Collaboration, Implementation, Municipalities, Mentalization, Social Functioning, CAMHS, Feasibility Study, Primary Health Care, Child and Adolescent Mental Health Services
- Medical subject headings
- Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Avenue to HelPBehavioural
The MAP intervention is based on AMBIT principles. A MAP team, consisting of designated employees from CAMHS and two municipalities, will be trained in AMBIT. A Key-Worker and a Mentalizing Case Manager will be assigned to each participant and step into the existing network, taking responsibility for integrating AMBIT principles into all aspects of the work with and around the young person. The Key-worker from the MAP team is responsible for reaching out to the young person at least once a week during the intervention. The Mentalizing Case Manager ensures that mentalization is upheld in the professional network. CAMHS will offer treatment as usual in accordance with the existing evidence-based clinical guidelines and best practice for any specific mental health disorder.
The MAP team members will meet once a week to work as a team and collaborate closely with family members and other potential informal caregivers. The network of helpers will meet and coordinate monthly.
Management as UsualBehavioural
Participants in the control group will receive non-manualized, standard treatment in CAMHS in collaboration with their municipality of residence, following local practice and guidelines. The MAU will be slightly enhanced compared to standard treatment: a) the young people will have an open case file during one year of participation in the MAP project (and longer if indicated), and b) the standard care services will receive feedback from the research assessment at baseline (after approval of the specific content from parents and the young person) in order to help the young person's caseworker to coordinate the support. These enhancements are made to improve the cohesion of care for the young person, yet without applying the mentalization-based AMBIT principles and MAP teams of the MAP treatment condition.
principles applied in the MAP treatment condition.
| Study group | Role | What they receive |
|---|---|---|
| MAP intervention | Experimental | Participants in the experimental arm of the MAP-Project will receive one year of treatment with the MAP-intervention. Receives: Behavioral: My Avenue to HelP |
| Management as Usual, MAU | Active comparator | Management as Usual will be carried out in the diverse municipalities of residence of the control and the Child and Adolescent Mental Health Services in Region Zealand. Receives: Behavioral: Management as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Outcome 1: Recruitment
Feasibility outcome 1 will be assessed by calculating the proportion of families that accept inclusion out of those who fulfill inclusion criteria. The intervention will be deemed acceptable if ≥50% of the families that are eligible (assessed at an informational meeting) also consent to participate in the MAP study.
Measured: 8 weeks after the last patient is enrolled
Feasibility Outcome 2: Adherence to treatment protocol
Feasibility outcome 2 will be assessed by contacting the Keyworker monthly to inquire about the contacts made/attempted by the Keyworker to the young person/network around the young person. Type of contact made between the Keyworker and the young person, and alternatively whom the Keyworker was in contact with within the indigenous network of the young person, in cases where the young person does not want direct contact with the Keyworker, will be registered as well. The intervention will be deemed acceptable if ≥70% of youths in the MAP intervention do not experience a pause of 4 continuous weeks between contacts.
Measured: Weekly registration of the contact between the young person and the keyworker from baseline and during the complete 52 weeks of intervention.
Feasibility Outcome 3: Satisfaction with the intervention
Feasibility outcome 3 regarding the satisfaction with treatment in MAP will be assessed using item 16.4 of the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥70% of youths and parents would recommend MAP to a friend.
Measured: Assessment within + / - 2 weeks after end of treatment
Feasibility Outcome 4: Satisfaction with the intervention
Feasibility outcome 4 will be assessed by a questionnaire developed for the MAP project and will be delivered to all workers (in the MAP teams) and leaders involved in MAP in Roskilde, Lejre, and CAMHS. The intervention will be deemed acceptable if >70% of MAP team staff and leaders will continue to prioritize the intervention.
Measured: Assessment within 2 weeks after the intervention period ends.
Feasibility Outcome 5: Reliability of the measurement of change in youth's social function
Feasibility outcome 5 will be deemed acceptable if ≥70% of youths who consented to participate in the MAP project, participated in the 'Personal and Social Performance Scale Interviews at baseline and after 1 year.
Measured: Assessment within 2 weeks after the intervention period ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start25 Mar 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health CareStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pia Jeppesen
- Sponsor type
- University, hospital or other
- Collaborators
- Lejre Municipality, Roskilde Municipality, Child and Adolescent Mental Health Services, Region Zealand, Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor-investigator, Pia Jeppesen, Psychiatric Research Unit, Region Zealand, Denmark
- Investigators
- Pia Jeppesen, Professor, MD, Principal investigator, University of Copenhagen and head of the Research Department in the Child and Adolescent Mental Health Services, Region ZealandMartin Køster Rimvall, PhD, MD, Principal investigator, Research Department in the Child and Adolescent Mental Health Services, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886165
- Sponsor's protocol ID
- SJ-1084
- Other IDs
- P-2024-17167
- Acronym
- MAP
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The pseudonymous quantitative data can be made available from six months after the publication date of the scientific articles written by the PhD student (from 2029). Proposals for use of data and requests for access should be directed to the principal investigator Pia Jeppesen, mail: pijep@regionsjaelland.dk. To gain access, researchers will need to sign a data access agreement with the Department of Child and Adolescent Psychiatry, Copenhagen University Hospital - Psychiatry Region Zealand, Roskilde, Denmark. The pseudonymous individual participant data can be made available to investigators for research that have been approved by independent review committees. The data access will be granted on a case-by-case basis by the principal investigator. Access will be granted to the extent permissible by the General Data Protection Regulation and the Danish Data Protection Act. Making the data available may require approval from the Danish Data Protection Authority.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Avenue to helP - Adaptive Mentalization-based Integrative Treatment Compared to Management as Usual for Youths With Multiple Problems: a Non-Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06886165
- Acronym / sponsor ID
- MAP / SJ-1084
- Conditions
- Mental Health Care, AMBIT, Adaptive Mentalization-Based Integrative Treatment, Child and Adolescent Psychiatry, Health Care Professionals, Mental Health Services
- Keywords
- AMBIT, Adative Mentalization-Based Integrative Treatment, Child and Adolescent Psychiatry, Cross-sectoral Collaboration, Interdisiplinary Collaboration, Implementation, Municipalities, Mentalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pia JeppesenUniversity, hospital or other
- Collaborators
- Lejre Municipality, Roskilde Municipality, Child and Adolescent Mental Health Services, Region Zealand, Copenhagen University Hospital, Hvidovre
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- 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.
My Avenue to HelP (MAP) is a non-randomized feasibility study testing the implementation of a cross-sectoral collaboration targeted youths, aged 12-17 years, with multiple social and psychological problems. MAP is a one-year intervention based on Adaptive Mentalization-Based Integrative Treatment (AMBIT). MAP is not a new treatment method, but rather a new way of offering and organizing support in the existing network around the young person. The objective is to create a new way for professionals across sectors to collaborate in supporting our most vulnerable youth. Thereby, the investigators aim to benefit the youths by incorporating a mentalizing stance to promote lasting changes beyond the intervention period. The MAP Project will run from 2025 to 2027.
The research will consist of two work packages (WPs)
- WP1 will test the feasibility of the MAP project examining a) whether young people can be successfully recruited to the project b) if the evaluation design and methods are feasible and c) if the intervention is feasible to participants and employees (quantitatively).
- WP2 will assess implementation determinants and evaluate the implementation strategies employed in the project. Furthermore, the acceptability of the intervention will qualitatively be assessed by interviews with selected participants, their parents, as well as employees.
Participants:
In total 60 youths aged 12-17 years from Region Zealand, Denmark:
- 40 youths will be enrolled and receive the one-year MAP Intervention; 30 youths residing in Roskilde Municipality and 10 residing in Lejre Municipality
- 20 youths from other municipalities in Region Zealand will be included in the trial as a control group.
To assess the nature and extent of the mental health problems and potential psychiatric disorders among the participating youths, the parents and the young person will be asked to complete an online questionnaire (Development and Well-Being Assessment (DAWBA)).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAP intervention | Experimental | Behavioral: My Avenue to HelPParticipants in the experimental arm of the MAP-Project will receive one year of treatment with the MAP-intervention. |
| Management as Usual, MAU | Active comparator | Behavioral: Management as UsualManagement as Usual will be carried out in the diverse municipalities of residence of the control and the Child and Adolescent Mental Health Services in Region Zealand. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Criterium A) Documented record of multiple problems defined as at least 2 of the following: (i) Absence from school / non-adherence to education (ii) Risk behaviors like alcohol or cannabis abuse, or repeated suicide attempts or self-harm requiring somatic treatment.(iii) Repeated visits at emergency-, trauma-, or acute wards. And/or one of the following: (iv) Contact with police or legal justice system. (v) Homelessness within the last year.
- Criterium B) Age 12-17 years at time of inclusion.
- Criterium C) Strong indication of mental disorders defined as a diagnosis of a mental disorder. The type of mental disorders will be further substantiated using the DAWBA after recruitment (Goodman et al., 2000).
- Criterium D) Written/signed informed consent from all legal guardians (in most cases both parents) and oral consent from youths aged 15 years and older. Written/signed informed consent from the youths themselves will be collected when they turn 18 if they do so during the study period.
Key exclusion criteria (2 listed)
- Indications of substantial intellectual disability corresponding to IQ below 50, or a level of daily and social functions that do not enable participation in research (e.g., if the young person is not deemed to have the capacity to understand the implications of the study and provide oral consent).
- Not living in Region Zealand.
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 |
|---|---|---|
| My Avenue to HelPThe MAP intervention is based on AMBIT principles. A MAP team, consisting of designated employees from CAMHS and two municipalities, will be trained in AMBIT. A Key-Worker and a Mentalizing Case Manager will be assigned to each participant and step into the existing network, taking responsibility for integrating AMBIT principles into all aspects of the work with and around the young person. The Key-worker from the MAP team is responsible for reaching out to the young person at least once a week during the intervention. The Mentalizing Case Manager ensures that mentalization is upheld in the professional network. CAMHS will offer treatment as usual in accordance with the existing evidence-based clinical guidelines and best practice for any specific mental health disorder. The MAP team members will meet once a week to work as a team and collaborate closely with family members and other potential informal caregivers. The network of helpers will meet and coordinate monthly. | Behavioural | MAP intervention |
| Management as UsualParticipants in the control group will receive non-manualized, standard treatment in CAMHS in collaboration with their municipality of residence, following local practice and guidelines. The MAU will be slightly enhanced compared to standard treatment: a) the young people will have an open case file during one year of participation in the MAP project (and longer if indicated), and b) the standard care services will receive feedback from the research assessment at baseline (after approval of the specific content from parents and the young person) in order to help the young person's caseworker to coordinate the support. These enhancements are made to improve the cohesion of care for the young person, yet without applying the mentalization-based AMBIT principles and MAP teams of the MAP treatment condition. principles applied in the MAP treatment condition. | Behavioural | Management as Usual, MAU |
Primary outcome
Feasibility Outcome 1: Recruitment
Time frame: 8 weeks after the last patient is enrolled
Feasibility outcome 1 will be assessed by calculating the proportion of families that accept inclusion out of those who fulfill inclusion criteria. The intervention will be deemed acceptable if ≥50% of the families that are eligible (assessed at an informational meeting) also consent to participate in the MAP study.
Feasibility Outcome 2: Adherence to treatment protocol
Time frame: Weekly registration of the contact between the young person and the keyworker from baseline and during the complete 52 weeks of intervention.
Feasibility outcome 2 will be assessed by contacting the Keyworker monthly to inquire about the contacts made/attempted by the Keyworker to the young person/network around the young person. Type of contact made between the Keyworker and the young person, and alternatively whom the Keyworker was in contact with within the indigenous network of the young person, in cases where the young person does not want direct contact with the Keyworker, will be registered as well. The intervention will be deemed acceptable if ≥70% of youths in the MAP intervention do not experience a pause of 4 continuous weeks between contacts.
Feasibility Outcome 3: Satisfaction with the intervention
Time frame: Assessment within + / - 2 weeks after end of treatment
Feasibility outcome 3 regarding the satisfaction with treatment in MAP will be assessed using item 16.4 of the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if ≥70% of youths and parents would recommend MAP to a friend.
Feasibility Outcome 4: Satisfaction with the intervention
Time frame: Assessment within 2 weeks after the intervention period ends.
Feasibility outcome 4 will be assessed by a questionnaire developed for the MAP project and will be delivered to all workers (in the MAP teams) and leaders involved in MAP in Roskilde, Lejre, and CAMHS. The intervention will be deemed acceptable if >70% of MAP team staff and leaders will continue to prioritize the intervention.
Feasibility Outcome 5: Reliability of the measurement of change in youth's social function
Time frame: Assessment within 2 weeks after the intervention period ends.
Feasibility outcome 5 will be deemed acceptable if ≥70% of youths who consented to participate in the MAP project, participated in the 'Personal and Social Performance Scale Interviews at baseline and after 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. The pseudonymous quantitative data can be made available from six months after the publication date of the scientific articles written by the PhD student (from 2029). Proposals for use of data and requests for access should be directed to the principal investigator Pia Jeppesen, mail: pijep@regionsjaelland.dk. To gain access, researchers will need to sign a data access agreement with the Department of Child and Adolescent Psychiatry, Copenhagen University Hospital - Psychiatry Region Zealand, Roskilde, Denmark. The pseudonymous individual participant data can be made available to investigators for research that have been approved by independent review committees. The data access will be granted on a case-by-case basis by the principal investigator. Access will be granted to the extent permissible by the General Data Protection Regulation and the Danish Data Protection Act. Making the data available may require approval from the Danish Data Protection Authority.
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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.
Pia Jeppesen, Professor, MD principal investigator
University of Copenhagen and head of the Research Department in the Child and Adolescent Mental Health Services, Region Zealand
Martin Køster Rimvall, PhD, MD principal investigator
Research Department in the Child and Adolescent Mental Health Services, Region Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Avenue to HelP and Management as Usual in people with Mental Health Care and AMBIT, run by Pia Jeppesen at 1 site in Denmark.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pia Jeppesen, Professor, MD (+45 58538002, pijep@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Outcome 1: Recruitment (time frame: 8 weeks after the last patient is enrolled). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.