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

Обзор

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)).

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Feasibility Outcome 1: Recruitment [Срок оценки: 8 weeks after the last patient is enrolled]
• Feasibility Outcome 2: Adherence to treatment protocol [Срок оценки: 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 [Срок оценки: Assessment within + / - 2 weeks after end of treatment]
• Feasibility Outcome 4: Satisfaction with the intervention [Срок оценки: Assessment within 2 weeks after the intervention period ends.]
• Feasibility Outcome 5: Reliability of the measurement of change in youth's social function [Срок оценки: Assessment within 2 weeks after the intervention period ends.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Child and Adolescent Psychiatric Department, Psychiatry Region Zealand — Roskilde

Идентификаторы

NCT: NCT06886165 · SJ-1084 · P-2024-17167

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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