NCT06886165 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pia Jeppesen |
| Condition | Mental Health Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-25 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)).
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.
Contact & Investigator
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
Frequently Asked Questions
Who can join the NCT06886165 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Mental Health Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06886165 currently recruiting?
Yes, NCT06886165 is actively recruiting participants. Contact the research team at pijep@regionsjaelland.dk for enrollment information.
Where is the NCT06886165 trial being conducted?
This trial is being conducted at Roskilde, Denmark.
Who is sponsoring the NCT06886165 clinical trial?
NCT06886165 is sponsored by Pia Jeppesen. The principal investigator is Pia Jeppesen, Professor, MD at University of Copenhagen and head of the Research Department in the Child and Adolescent Mental Health Services, Region Zealand. The trial plans to enroll 60 participants.