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 (MAP)

Pia Jeppesen

Status: Enrolling

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

Treatments: Behavioral: My Avenue to HelP; Behavioral: Management as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06886165

P-2024-17167 (Other Identifier)

SJ-1084

Details and patient eligibility

About

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)).

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MAP intervention

Experimental group

Description:

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

Treatment:

Behavioral: My Avenue to HelP

Management as Usual, MAU

Active Comparator group

Description:

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.

Treatment:

Behavioral: Management as Usual