NCT06307366

Brief Summary

Despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. Neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. Furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. To date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. Therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 5, 2024

Last Update Submit

March 11, 2024

Conditions

Keywords

mental illnessriskresilienceoffspringqualitative researchmood-psychosis spectrum

Outcome Measures

Primary Outcomes (1)

  • Themes around the topics (related to perceptions and experiences) explored.

    We developed an interview guide around the main themes (i) risk and resilience; (ii) information needs for care and counselling; and (iii) (biological) research to ensure key aspects relating to perceptions, experiences, and needs of participants around the chance risk for mental illness in (future) children will be covered during the interviews. It additionally allows the interviewer to ask follow-up questions on interesting perspectives put forth by participants.

    1 hour

Study Arms (1)

(Future) parents with (a partner with) mental illness in the mood-psychosis spectrum

The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old. If including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents.

Other: No intervention will be used

Interventions

This is a qualitative study, no intervention will be used

(Future) parents with (a partner with) mental illness in the mood-psychosis spectrum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The following participants will be included: (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum (psychotic disorder, bipolar disorder, severe depression); ≥ 18 years old. If including (future) parents with mental illness and their partners will turn out to be difficult given our timeframe, we will mitigate this by additionally including family members of people with mental illness, e.g. siblings or grandparents.

You may qualify if:

  • Having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression
  • At least 18 years old

You may not qualify if:

  • Insufficient proficiency of the Dutch language
  • No demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from Appelbaum \& Grisso, 1988).
  • Unable to give consent to all aspects of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3000CB, Netherlands

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Hilmar H. Bijma, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisanne AE van Houtum, PhD

CONTACT

Hilmar H Bijma, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral researcher designated by Prinicipal Investigator

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Only processed, group-level data (i.e., themes, subthemes) can be shared, given that interviews can be traced back to individual participants. The PI will verify the authenticity of the requesting researcher and will check whether their intentions are in line with the informed consent and whether the intended methodology is suitable and will approve the request before providing access to the data. A Data Transfer Agreement will be signed, and the Technology Transfer Office will be involved to ensure the appropriate agreements are made.

Locations