NCT05615324

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

The Randomized Clinical Trial SAFIR FAMILY TALK: a Short Family-based Early Intervention vs. Service as Usual for Children of Parents With Mental Illness in the Capital Region of Denmark

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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.

Detailed description

Children of parents with mental illness are at increased risk for mental illness themselves and therefore interventions aimed at mitigating this risk are important. The Family Talk Preventive Intervention was developed by William Beardslee in the 1980's for families with parental depression but has been widely used to treat families with other mental health conditions as well. Nevertheless, only few high-quality clinical trials exist, and the results are inconclusive. The objective of this clinical trial is to test the effect of Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness and receiving treatment from a secondary mental health service within the last two years from inclusion. Participants are the parent with a mental illness, their youngest child aged 7-17 years and the other parent of this child. The hypothesis is that Family Talk will be superior to service as usual in improving the child's level of functioning, the parent's sense of competence and family functioning at 4 moths follow-up. Participants will undergo interviews and fill out questionnaires at baseline, four- and twelve months follow-up assessments. Half of the families 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 and other measures including child's quality of life, communication in the family and parental personal recovery.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2022-11-14
• Last updated: 2025-07-16

Locations

1 site across 1 country: Denmark