Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P-2024-17167 | Other Identifier | Region Zealand |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lejre Municipality | UNKNOWN |
| Roskilde Municipality | UNKNOWN |
| Child and Adolescent Mental Health Services, Region Zealand | UNKNOWN |
| Copenhagen University Hospital, Hvidovre |
Not provided
Not provided
Not provided
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)
Participants:
In total 60 youths aged 12-17 years from Region Zealand, Denmark:
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)).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAP intervention | Experimental | Participants in the experimental arm of the MAP-Project will receive one year of treatment with the MAP-intervention. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pia Jeppesen, Professor, MD | Contact | +45 58538002 | pijep@regionsjaelland.dk | |
| Kristine T Hansen, MD, ph.D-Student | Contact | +4558538002 | ktrh@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Psychiatric Department, Psychiatry Region Zealand | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
The pseudonymous quantitative data can be made available from six months after the publication date of the scientific articles written by the PhD student (from 2029). Proposals for use of data and requests for access should be directed to the principal investigator Pia Jeppesen, mail: pijep@regionsjaelland.dk.
To gain access, researchers will need to sign a data access agreement with the Department of Child and Adolescent Psychiatry, Copenhagen University Hospital - Psychiatry Region Zealand, Roskilde, Denmark. The pseudonymous individual participant data can be made available to investigators for research that have been approved by independent review committees. The data access will be granted on a case-by-case basis by the principal investigator. Access will be granted 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 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.
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.
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| The PSP interview will be conducted at baseline and at end of intervention (after 52 weeks, +/- 14 days). |
| 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 | 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 | 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. | The assessment will be conducted at baseline and at end of treatment (after 1 year, +/- 14 days). |
| 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. | 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. |
| Secondary exploratory outcomes: Change in personal recovery | Change in personal recovery, self-reported, measured by the Brief INSPIRE-O, which has recently been validated in a Danish context. The Brief INSPIRE-O includes 5 questions scored on a Likert scale from 0 (low well-being) to 4 (high well-being) resulting in a sum score of 0 to 20. | 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. |
| Secondary exploratory outcomes: Change in health-related quality of life | Change in health-related quality of life measured by the Child Health Utility 9D (CHU9D), self- and parent-reported. All nine items of the CHU9D have five unnumbered response options which are converted to scores of 1-5, resulting in a sum score of 9 to 45. The instrument allows for the calculation of Quality-Adjusted Life Years (QALYs). It is a measure used to assess how many good life years are gained or lost by introducing new health technology or organization. | 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. |
| Secondary exploratory outcomes: Mental health problems and disorders | Mental health problems and disorders measured by the Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1999), self- and parent-reported. The SDQ contains 25 items, which cover five subscales relating to the children's emotional problems, peer problems, behavioral problems, hyperactivity and pro-social behavior. Responses to the subscales on emotional problems, peer problems, behavioral problems, and hyperactivity can be used to calculate a total difficulties score. Each subscale score ranges from 0-10, implying that the total difficulties score ranges from 0 to 40 An impact score is calculated from five items; whether the difficulties upset or distress the child and how much the difficulties interfere with home life, friendships, classroom learning, and leisure activities. Each item is scored on a scale from 0 to 10. To score 1 or 2, the interference from the difficulties in that domain must be assessed to either "quite a lot" or "a great deal", resulting in an impact score. | 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. |
| Secondary exploratory outcomes: Participant satisfaction | Participant satisfaction measured with the Client Satisfaction Questionnaire, self-reported. The scale consists of 8 questions scored on a 4-point Likert Scale ranging from low to high satisfaction with different aspects of the intervention. The total score ranges from 8 (minimum value [bad outcome], low satisfaction) to 32 (maximum value [good outcome], high satisfaction). | The questionnaire is administered to the participant at the end of intervention (after 52 weeks + / - 2 weeks) |
| Secondary exploratory outcomes: Parental satisfaction | Parental satisfaction and experience with the treatment of their child will be measured with the Experience of Service Questionnaire. The scale consists of 10 questions scored on a 3-point Likert Scale. The total score ranges from 0 (minimum value [bad outcome], poor satisfaction]) to 20 (maximum value [good outcome], high satisfaction]). | The questionnaire is administered to the primary parent/caregiver at the end of intervention (after 52 weeks + / - 2 weeks) |
| Secondary exploratory outcomes: Adherence to planned care in CAMHS | Adherence to planned care in CAMHS and the use of emergency healthcare will be assessed through information from the young person's patient records. | 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 |
| Principal Investigator |
| ID | Term |
|---|---|
| D012917 | Social Adjustment |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided