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

NCT05615324 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-07-16

No results posted yet for this study

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.

Conditions

  • Mental Disorder
  • Family
  • Child
  • Parenting
  • Resilience
  • Prevention

Interventions

BEHAVIORAL

Family Talk Preventive Intervention

This is a clinician facilitated, psychoeducational preventive intervention that includes on average 8 sessions designed to improve family communication and understanding of parental mental illness, improve interpersonal relationships, and promote child resilience and utilization of social support. An important tool throughout the intervention is the logbook which the clinician uses for taking notes with each family. The logbook prescribes the planned topics to be covered in each session and the contents of the sessions are noted in the logbook by the clinicians.

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY
  • Sektion for Tværsektoriel forskning - Region Hovedstaden

    collaborator UNKNOWN
  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Anne Ranning, PhD · Mental Health Services in the Capital Region of Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615324 on ClinicalTrials.gov