Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-11-11; most recent amendment 2025-07-11.
Status change: Recruiting → Active, Not Recruiting 2025-03-10
Trial Details
NCT Number NCT05615324
Lead Sponsor Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborators: TrygFonden, Denmark, Sektion for Tværsektoriel forskning - Region Hovedstaden
Conditions Mental Disorder, Family, Child, Parenting, Resilience, Prevention
Enrollment 800 participants
Start Date 2020-08-01
Primary Completion 2024-10-31 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-16