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The MARIO intervention study

Intervention for mood disorder symptoms in children of parents with psychiatric disorders - the MARIO intervention study - the MARIO intervention study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54855
Enrollment
200
Registered
2020-09-25
Start date
2022-04-28
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and bipolar disorder Gloom, feeling empty

Interventions

The investigational product is an online entry platform that is built for this&nbsp
study. The elements of three existing intervention components (KOPPsupport,&nbsp
Moodpep and Grow-it) will be integrated in this mobile online platform&nbsp
accessible through a link that participants receive from the MARIO team. Up to December 2025, the platform comprised three interventions. As of January 2026, KOPPsupport is no longer in use.&nbsp
Participants in the intervention groups will be able to choose between the&nbsp
interventions and participate in multiple interventions (also to participate in&nbsp
parts of an intervention). The MARIO study team will provide information on&nbsp
which intervention may be most suitable for the participant (for instance based&nbsp
on their age). The first intervention component until December 2025 was KOPPsupport (Woolderink et&nbsp
al., 2010) developed by the Trimbos Institute. KOPPsupport is an existing&nbsp
psycho-educational program for COPMI and is developed for participants in the&nbsp
age of 16-25 years. The duration of the intervention is ~8 weeks. Previously, the intervention worked as follows:&nbsp
Participants who register on the MARIO platform and click on the KOPPsupport intervention&nbsp
component will be directed towards the KOPPsupport environment and placed in a&nbsp
new group with other participants. In KOPPsupport, new groups will start at the&nbsp
same time with the intervention component, which is approximately once per&nbsp
month. This means that a MARIO participant who wants to participate in the&nbsp
KOPPsupport intervention component will have to wait for max. 4 weeks before&nbsp
he/she can start with the actual intervention component. From January

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
12 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Child has a parent with a psychiatric disorder, based on parent and/or child report - Child is in the age range of 10 - 26 years - Written informed consent of child and parent (depending on age of the child) - Fluent in Dutch

Exclusion criteria

Exclusion criteria: - Current depressive or BD disorder diagnosis and/or suicidality based on the K-SADS psychiatric interview that was conducted in the telephone interview as part of the online MARIO-screening study (METC number: 2019.486). However, in case of a mild current depressive episode during the MARIO-screening study, we will ask participants who gave permission for future studies if they agree on another K-SADS psychiatric interview (on mood symptoms and suicidality) after a period of 6 months. If they agree, and there is no current mood episode according to the K-SADS psychiatric interview, the participant is able to participate in the MARIO Intervention study. - Not having adequate access to laptop or mobile phone during the study period.

Design outcomes

Primary

MeasureTime frame
PHQ-9 measured with the MARIO-check (administered T0-T3). Of note, for some participants, part of the T0 assessment has already been conducted as part of the MARIO-screening study and those data will be used as baseline data for the intervention study.

Secondary

MeasureTime frame
- Endpoints: * Mania symptoms as measured with the MARIO-check (questions from the General Behavior Inventory (T0-T3) and K-SADS, administered (T0 en T3 if PHQ-9 >4) * Mood diagnosis will be determined by a telephone interview which is conducted at two time points (T0 and T3) using the K-SADS depression and mania sections. The K-SADS at T3 will only be conducted when the PHQ-9 total score is >=5 (indicating mild depressive symptoms (Kroenke, Spitzer & Williams, 2001)) at any of the time points. In case a subject is 18 years or younger, we will also administer the K-SADS by one of the parents. - Mediators (assessed at two or more time points, see Table 1): * Coping assessed with the Utrecht Coping List for Adolescents (UCL-A) * Sleep - Moderators (assessed T0): * child sex and age * parent sex and age * type of parental disorder (based on parent self-report or child report, obtained from the screening study) * age of onset parental disorder (based on parent self-report or child report obtained from the screening study) * number of affected parents (1 versus 2) (based on parent self-report or child report obtained from the screening study) * marital and/or household status of parent (based on parent self-report or child report obtained from the screening study) * income and educational level of parent (based on parent self-report or child report obtained from the screening study) * co-parent mood symptoms (based on parent self-report obtained from the Screening study)

Countries

Netherlands

Contacts

Public ContactA. Vreeker

Erasmus MC, Universitair Medisch Centrum Rotterdam

a.vreeker@erasmusmc.nl010-7032140

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026