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

NCT ID: NCT05615324

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Family Talk

families will receive a manualized, family-based intervention Family Talk of approximately 8 sessions with a trained, Family Talk interventionist.

Group Type: EXPERIMENTAL

Family Talk Preventive Intervention

Intervention Type: BEHAVIORAL

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.

Service as usual

Families in this arm will not receive any intervention from the research team but they may receive other services. It is likely that many will receive two sessions of talk intervention concerning parental mental health and child well-being from professionals in the mental health sector where the parent is treated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Beardslee's Family Intervention

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Sektion for Tværsektoriel forskning - Region Hovedstaden

UNKNOWN

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Anne Ranning

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Ranning, PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Services in the Capital Region of Denmark

Locations

Mental Health Services in the Capital Region

Hellerup, , Denmark

Countries

Denmark

References

Nielsen SS, Mikkelsen LJ, Quaade N, Gladstone TRG, Beardslee WR, Bonnemose K, Rosenberg NK, Hjorthoj C, Thorup AAE, Nordentoft M, Ranning A. 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. Trials. 2023 Apr 22;24(1):291. doi: 10.1186/s13063-023-07256-6.

Reference Type: DERIVED

PMID: 37087437 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

127849

Identifier Type: -

Identifier Source: org_study_id