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

NCT06886165 | Recruiting

• 2 other identifiers: SJ-1084P-2024-17167
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)).

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

Outcome Measures

Primary Outcomes (5)

• 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.

  8 weeks after the last patient is enrolled

• 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.

  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

  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.

  Assessment within + / - 2 weeks after end of treatment

• 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.

  Assessment within 2 weeks after the intervention period ends.

• Feasibility Outcome 5: Reliability of the measurement of change in youth's social function

  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.

  Assessment within 2 weeks after the intervention period ends.

Other Outcomes (10)

• Primary exploratory outcome: Change in youths' social function

  The PSP interview will be conducted at baseline and at end of intervention (after 52 weeks, +/- 14 days).

• Monitoring of adverse events

  Weekly screening for adverse events during the complete 52 weeks treatment.

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

  The assessment will be conducted at baseline and at end of treatment (after 1 year, +/- 14 days).

Study Arms (2)

MAP intervention

EXPERIMENTAL

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

Behavioral: My Avenue to HelP

Management as Usual, MAU

ACTIVE COMPARATOR

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.

Behavioral: Management as Usual

Interventions

My Avenue to HelP BEHAVIORAL

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 during the intervention. The Mentalizing Case Manager ensures that mentalization is upheld in the professional network. CAMHS will offer treatment as usual in accordance with the existing evidence-based clinical guidelines and best practice for any specific mental health disorder. The MAP team members will meet once a week to work as a team and collaborate closely with family members and other potential informal caregivers. The network of helpers will meet and coordinate monthly.

MAP intervention

Management as Usual BEHAVIORAL

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 specific content from parents and the young person) in order to help the young person's caseworker to coordinate the support. These enhancements are made to improve the cohesion of care for the young person, yet without applying the mentalization-based AMBIT principles and MAP teams of the MAP treatment condition. principles applied in the MAP treatment condition.

Management as Usual, MAU

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pia Jeppesen: lead
• Lejre Municipality: collaborator
• Roskilde Municipality: collaborator
• Child and Adolescent Mental Health Services, Region Zealand: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (1)

Child and Adolescent Psychiatric Department, Psychiatry Region Zealand

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Social Adjustment

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Pia Jeppesen, Professor, MD

  University of Copenhagen and head of the Research Department in the Child and Adolescent Mental Health Services, Region Zealand

  PRINCIPAL INVESTIGATOR

• Martin Køster Rimvall, PhD, MD

  Research Department in the Child and Adolescent Mental Health Services, Region Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Jeppesen, Professor, MD

CONTACT

+45 58538002; pijep@regionsjaelland.dk

Kristine T Hansen, MD, ph.D-Student

CONTACT

+4558538002; ktrh@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD, Head of Research, Department of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 20, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD including the SAP will become available 6 months after the publication of the summary of all results of the feasibility trial (expected access in 2029). The study protocol will be published during the period of recruitment of participants in 2025-26.
• Access Criteria: The IPD and supporting information will be available for researchers upon request for research that have been approved by independent review committees and to the extent permissible by the General Data Protection Regulation and the Danish Data Protection Act. Making the data available may require approval from the Danish Data Protection Authority. The pseudonymous quantitative data will be shared electronically in excel sheets.

Locations

DK (1)