NCT05615324 is a NA clinical trial of Family Talk Preventive Intervention in Mental Disorder, sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.

Who is sponsoring NCT05615324?

NCT05615324 is sponsored by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital.

What drugs are being tested in NCT05615324?

Interventions in NCT05615324: Family Talk Preventive Intervention.

What condition does NCT05615324 study?

NCT05615324 studies Mental Disorder, Family, Child, Parenting, Resilience, Prevention.

Is NCT05615324 still recruiting?

NCT05615324 is currently active, enrolled. Last updated 16 July 2025.

Last reviewed 2025-07-16 · How we verify

NCT05615324

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled NA Last updated 16 July 2025

What this trial tests

NA trial testing Family Talk Preventive Intervention in Mental Disorder in 800 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 August 2020

Primary endpoint
31 October 2024

31 October 2025

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	800
Start date	1 August 2020
Primary completion	31 October 2024
Estimated completion	31 October 2025
Sites	1 location across Denmark

Drugs / interventions tested

Family Talk Preventive Intervention

Conditions studied

Mental Disorder — all drugs for Mental Disorder →
Family — all drugs for Family →
Child — all drugs for Child →
Parenting — all drugs for Parenting →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

7 and older, any sex, with Mental Disorder or Family. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A study protocol for the randomized controlled trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.
Nielsen SS, Mikkelsen LJ, Quaade N, Gladstone TRG, et al · · 2023 · PMID 37087437 · DOI 10.1186/s13063-023-07256-6

Verify or expand the search:

Other recruiting trials for Mental Disorder

Currently open trials in the same condition.

NCT07010614 — Brain Stimulation to the Hippocampus in Schizophrenia · NA · recruiting
NCT06929533 — Pharmacogenomics-Supported Psychotropic Prescribing Trial · NA · recruiting
NCT06813066 — Simulating Psychotherapeutic Sessions With Generative Artificial Intelligence · NA · active not recruiting
NCT06376734 — Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness · Phase 2 · recruiting
NCT06625437 — ACT for HIV-Positive Men · NA · recruiting

Other Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital trials

Trials by the same sponsor.

NCT07404085 — Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations · NA · recruiting
NCT07302165 — PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be · NA · enrolling by invitation
NCT06919133 — The Effect of Digital Markers in the Self-management of Depressive Symptoms · NA · enrolling by invitation
NCT06755710 — Patient Engagement in PTSD Treatment (PEP) · NA · recruiting
NCT06993831 — ENGAGE: Virtual Reality-based Psychotherapy for Negative Symptoms in Schizophrenia · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05615324 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Last refreshed: 16 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05615324.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing