Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Care
AMBIT
Adaptive Mentalization-Based Integrative Treatment
Child and Adolescent Psychiatry
Health Care Professionals
Mental Health Services
Community Mental Health Services
Emergency Services, Psychiatric
Social Work, Psychiatric
Keywords: AMBIT
Adative Mentalization-Based Integrative Treatment
Child and Adolescent Psychiatry
Cross-sectoral Collaboration
Interdisiplinary Collaboration
Implementation
Municipalities
Mentalization
Social Functioning
CAMHS
Feasibility Study
Primary Health Care
Child and Adolescent Mental Health Services
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
Collaborators: name: Lejre Municipality
name: Roskilde Municipality
name: Child and Adolescent Mental Health Services, Region Zealand
name: Department of Clinical Research, Hvidovre University Hospital, Denmark
First posted: 2025-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Feasibility Outcome 1: Recruitment
timeFrame: 8 weeks after the last patient is enrolled
measure: Feasibility Outcome 2: Adherence to treatment protocol
timeFrame: Weekly registration of the contact between the young person and the keyworker from baseline and during the complete 52 weeks of intervention.
measure: Feasibility Outcome 3: Satisfaction with the intervention
timeFrame: Assessment within + / - 2 weeks after end of treatment
measure: Feasibility Outcome 4: Satisfaction with the intervention
timeFrame: Assessment within 2 weeks after the intervention period ends.
measure: Feasibility Outcome 5: Reliability of the measurement of change in youth's social function
timeFrame: Assessment within 2 weeks after the intervention period ends.
Secondary outcomes:
Other outcomes:
measure: Primary exploratory outcome: Change in youths' social function
timeFrame: The PSP interview will be conducted at baseline and at end of intervention (after 52 weeks, +/- 14 days).
measure: Monitoring of adverse events
timeFrame: Weekly screening for adverse events during the complete 52 weeks treatment.
measure: Secondary exploratory outcomes: Participation in education, employment, or training in the past four weeks
timeFrame: The assessment will be conducted at baseline and at end of treatment (after 1 year, +/- 14 days).
measure: Secondary exploratory outcomes: Change in well-being
timeFrame: The questionnaire is administered to the young person and the primary parent/caregiver at baseline, midway (after 182 days +/- 14 days), and after 1 year (365 days +/- 30 days) to measure changes before, during, and after the treatment period.
measure: Secondary exploratory outcomes: Change in personal recovery
timeFrame: The questionnaire is administered to the young person and the primary parent/caregiver at baseline, midway (after 182 days +/- 14 days), and after 1 year (365 days +/- 30 days) to measure changes before, during, and after the treatment period.
measure: Secondary exploratory outcomes: Change in health-related quality of life
timeFrame: The questionnaire is administered to the young person and the primary parent/caregiver at baseline, midway (after 182 days +/- 14 days), and after 1 year (365 days +/- 30 days) to measure changes before, during, and after the treatment period.
measure: Secondary exploratory outcomes: Mental health problems and disorders
timeFrame: The questionnaire is administered to the young person and the primary parent/caregiver at baseline, midway (after 182 days +/- 14 days), and after 1 year (365 days +/- 30 days) to measure changes before, during, and after the treatment period.
measure: Secondary exploratory outcomes: Participant satisfaction
timeFrame: The questionnaire is administered to the participant at the end of intervention (after 52 weeks + / - 2 weeks)
measure: Secondary exploratory outcomes: Parental satisfaction
timeFrame: The questionnaire is administered to the primary parent/caregiver at the end of intervention (after 52 weeks + / - 2 weeks)
measure: Secondary exploratory outcomes: Adherence to planned care in CAMHS
timeFrame: All planned and completed appointments with CAMHS will be documented by the investigators during the complete 52 weeks of intervention. The investigators will screen for emergency healthcare service use weekly during the complete 52 weeks of intervention
Locations:
Study officials:
affiliation: University of Copenhagen and head of the Research Department in the Child and Adolescent Mental Health Services, Region Zealand
name: Pia Jeppesen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Department in the Child and Adolescent Mental Health Services, Region Zealand
name: Martin Køster Rimvall, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: