Mental IllnessPANDAccNCT06307366
Perceptions and Experiences of (Family Members of) People With Mental Illness About the Chance for Mental Illness in (Future) Children, and Needs for Care and Research
An observational study of Mental Illness, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2024to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3000CB
Lisanne AE van Houtum, PhD, +31107037005, l.vanhoutum@erasmusmc.nl
Hilmar H Bijma, MD, PhD, +31107036109, h.bijma@erasmusmc.nl
About this study
Official title: Perceptions and Experiences of (Future) Parents With Mental Illness and Family Members of People With Mental Illness About Risk for Mental Illness in (Future) Children, Potential Resilience Factors, and Needs for Care and Research
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.
- Conditions
- Mental Illness
- Being tested
- No intervention will be used
- Keywords
- mental illness, risk, resilience, offspring, qualitative research, mood-psychosis spectrum
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be usedOther
This is a qualitative study, no intervention will be used
| Study group | Role | What they receive |
|---|---|---|
| (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. Receives: Other: No intervention will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisanne van Houtum, Erasmus Medical Center
- Investigators
- Hilmar H. Bijma, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307366
- Sponsor's protocol ID
- ErasmusMC10365
- Acronym
- PANDAcc
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions and Experiences of (Future) Parents With Mental Illness and Family Members of People With Mental Illness About Risk for Mental Illness in (Future) Children, Potential Resilience Factors, and Needs for Care and Research
- ClinicalTrials.gov ID
- NCT06307366
- Acronym / sponsor ID
- PANDAcc / ErasmusMC10365
- Conditions
- Mental Illness
- Keywords
- mental illness, risk, resilience, offspring, qualitative research, mood-psychosis spectrum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum | – | Other: No intervention will be usedThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be usedThis is a qualitative study, no intervention will be used | Other | (Future) parents with (a partner with) mental illness in the mood-psychosis spectrum |
Primary outcome
Themes around the topics (related to perceptions and experiences) explored.
Time frame: 1 hour
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilmar H. Bijma, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Illness, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisanne AE van Houtum, PhD (+31107037005, l.vanhoutum@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes around the topics (related to perceptions and experiences) explored. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.