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

NCT05615324 | Active Not Recruiting DMC

• 1 other identifier: 127849
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder; Family; Child; Parenting; Resilience; Prevention

Keywords

Parental mental illness; COPMI; Intervention; Family Talk; Mental Illness; Beardslee

Outcome Measures

Primary Outcomes (3)

• Change in Children's Global Assessment Scale (CGAS)

  A clinician rated measurement to asses general functioning in children. Information is obtained from both the child and the parents. Scale from 1-100. High score indicates better the functioning.

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in Family Assessment Device (FAD) (Parent-rated)

  A 60 item parent report questionnaire assessing each individual's perception of his or her family functioning. The FAD is based on a comprehensive sociological theory about different functions of a family. Scale from 1-4. Low score represents better outcome.

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in Parenting Sense of Competency (PSOC)

  A 16 item parent report questionnaire assessing overall parenting sense of competence. Each item rated on a 6-point Likert scale. Total scale from 16-96. A higher score indicates a higher parenting sense of competency.

  Assessment at baseline, 4 months and 12 months after baseline.

Secondary Outcomes (4)

• Change in Beck's Youth Inventories (BYI-II)

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in Parent-Child Communication (Child-rated)

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in Response to parents' mood

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in parental recovery (Brief INSPIRE-O)

  Assessment at baseline, 4 months and 12 months after baseline.

Other Outcomes (16)

• Change in Child-rated Strengths and Difficulties Questionnaire (SDQ)

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in Parent-rated Strengths and Difficulties Questionnaire (SDQ)

  Assessment at baseline, 4 months and 12 months after baseline.

• Change in children's Quality of Life (Kidsscreen-27)

  Assessment at baseline, 4 months and 12 months after baseline.

Study Arms (2)

Family Talk

EXPERIMENTAL

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

Behavioral: Family Talk Preventive Intervention

Service as usual

NO INTERVENTION

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.

Interventions

Family Talk Preventive Intervention 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.

Also known as: Beardslee's Family Intervention

Family Talk

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The other parent of this child may or may not have a mental health condition.

You may not qualify if:

• \- Not speaking Danish or English.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator
• Sektion for Tværsektoriel forskning - Region Hovedstaden: collaborator

Study Sites (1)

Mental Health Services in the Capital Region

Hellerup, 2900, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37087437 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Anne Ranning, PhD

  Mental Health Services in the Capital Region of Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research assistants and ph.d.-students in charge of the assessment are blinded in regards to which treatment the families have received. All outcome scores are set in consensus with the other outcome assessors. In case of unblinding, it is the team setting the score, not the assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: SAFIR Family Talk is i randomized controlled trial carried out in the capital region of Denmark. The trial examines the Family Talk intervention, developed by William Beardslee, as opposed to service as usual (SAU) in out patient clinics in the public health sector in the capital region of denmark. All participating families will be assessed at baseline, 4 months follow-up and 12 months follow-up.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 14, 2022
• Study Start: August 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)