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

Feasibility Outcome 1: Recruitment

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 2: Adherence to treatment protocol

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

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.

Feasibility Outcome 4: Satisfaction with the intervention

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.

Primary exploratory outcome: Change in youths' social function

Change in youths' social function covering four domains (socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors, measured with the Personal and Social Performance (PSP) Scale, rated by researchers using multiple sources of information. Overall functioning will be scored on a scale from 0 (minimum value \[worst outcome\], complete lack of autonomy) to 100 (maximum value \[best outcome\], excellent functioning).

Monitoring of adverse events

We anticipate no or minimal adverse effects or adverse events related to the AMBIT and MAU interventions in the trial. The independent observer will be responsible for the recording and classification of events based on the weekly contact with the participants and surveillance of the electronic health record system (Sundhedsplatformen) to cover adverse events according to the following definitions: Adverse Event (AE): any undesirable medical event occurring to a participant during a clinical trial, which does not necessarily have a causal relationship with the intervention. Adverse Reaction (AR): any undesirable and unintended medical response related to the intervention occurring to a participant during a clinical trial. Serious Adverse Event (SAE): any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospital stay

Secondary exploratory outcomes: Participation in education, employment, or training in the past four weeks

Participation in education, employment, or training in the past four weeks, rated by an independent observer based on multiple sources of information from a short interview in connection with the Personal and Social Performance Scale assessment.

Secondary exploratory outcomes: Change in well-being

Change in well-being, self-reported with the WHO-5 well-being index. The WHO-5 includes 5 questions scored on a Likert scale from 0 (low well-being) to 5 (high well-being) resulting in a sum score of 0 to 25.