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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility Outcome 1: Recruitment
研究概览
简要总结
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)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Management as Usual (Behavioral)
MAP intervention
Participants in the experimental arm of the MAP-Project will receive one year of treatment with the MAP-intervention.
干预措施: My Avenue to HelP (Behavioral)
结局指标
主要结局
Feasibility Outcome 1: Recruitment
时间窗: 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 4: Satisfaction with the intervention
时间窗: 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
时间窗: 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.
Feasibility Outcome 2: Adherence to treatment protocol
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Pia Jeppesen
Professor, PhD, Head of Research, Department of Child and Adolescent Psychiatry
Psychiatric Research Unit, Region Zealand, Denmark