Active — Not RecruitingNot Applicable

SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention

Denmark800 participantsStarted 2020-08-01

Plain-language summary

The goal of this clinical trial is to test the effect of the Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness. Participants are the parent with a mental illness receiving treatment from a secondary mental health service within the last two years from inclusion, their youngest child aged 7-17 years and the other parent of this child. The main questions it aims to answer are: Is Family Talk superior to service as usual regarding improving? * The child's level of functioning * The parent's sense of competence * Family functioning Participants will undergo interviews and fill out questionnaires. Half will be randomized to Family Talk and receive a manualized, family-based intervention of approximately 8 conversations with a trained, Family Talk interventionist. The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector. The researchers will compare the two groups on child's level of functioning, parental sense of competence and family functioning.

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least one parent must have been in contact with the secondary health care system due to a mental health condition within the last two years before inclusion. * The parent should have at least one child aged 7-17 years at the time of inclusion. * The other parent of this child may or may not have a mental health condition. Exclusion Criteria: \- Not speaking Danish or English.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Children's Global Assessment Scale (CGAS)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.

Change in Family Assessment Device (FAD) (Parent-rated)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.

Change in Parenting Sense of Competency (PSOC)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.

Trial details

NCT IDNCT05615324

SponsorMental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Mental Disorder trials

Plain-language summary

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Children's Global Assessment Scale (CGAS)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.

Change in Family Assessment Device (FAD) (Parent-rated)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.

Change in Parenting Sense of Competency (PSOC)

Timeframe: Assessment at baseline, 4 months and 12 months after baseline.