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

NCT ID: NCT06886165

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2028-01-31

Brief 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). 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)).

Conditions

Mental Health Care; AMBIT; Adaptive Mentalization-Based Integrative Treatment; Child and Adolescent Psychiatry; Health Care Professionals; Mental Health Services; Community Mental Health Services; Emergency Services, Psychiatric; Social Work, Psychiatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAP intervention

Participants in the experimental arm of the MAP-Project will receive one year of treatment with the MAP-intervention.

Group Type: EXPERIMENTAL

My Avenue to HelP

Intervention Type: BEHAVIORAL

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 Usual, MAU

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.

Group Type: ACTIVE_COMPARATOR

Management as Usual

Intervention Type: BEHAVIORAL

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.

Interventions

My Avenue to HelP

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.

Intervention Type: BEHAVIORAL

Management as Usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lejre Municipality

UNKNOWN

Sponsor Role: collaborator

Roskilde Municipality

UNKNOWN

Sponsor Role: collaborator

Child and Adolescent Mental Health Services, Region Zealand

UNKNOWN

Sponsor Role: collaborator

Department of Clinical Research, Hvidovre University Hospital, Denmark

UNKNOWN

Sponsor Role: collaborator

Pia Jeppesen

OTHER

Sponsor Role: lead

Responsible Party

Pia Jeppesen

Professor, PhD, Head of Research, Department of Child and Adolescent Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pia Jeppesen, Professor, MD

Role: 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

Role: PRINCIPAL_INVESTIGATOR

Research Department in the Child and Adolescent Mental Health Services, Region Zealand

Locations

Child and Adolescent Psychiatric Department, Psychiatry Region Zealand

Roskilde, Region Sjælland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Pia Jeppesen, Professor, MD

Role: CONTACT

pijep@regionsjaelland.dk

+45 58538002

Kristine T Hansen, MD, ph.D-Student

Role: CONTACT

ktrh@regionsjaelland.dk

+4558538002

Facility Contacts

Pia Jeppesen, Professor, Ph.d.

Role: primary

pijep@regionsjaelland.dk

23969929

Kristine Hansen, MD

Role: backup

ktrh@regsj.dk

+4553639199

Other Identifiers

P-2024-17167

Identifier Type: OTHER

Identifier Source: secondary_id

SJ-1084

Identifier Type: -

Identifier Source: org_study_id