Mental DisorderNCT05615324
SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention
A study testing Family Talk Preventive Intervention in people with Mental Disorder and Family, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Family, Child
- What is being tested?
- Family Talk Preventive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2020to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not speaking Danish or English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Family Talk Preventive Intervention
- Keywords
- Parental mental illness, COPMI, Intervention, Family Talk, Mental Illness, Beardslee
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Talk Preventive InterventionBehavioural
Also called Beardslee's Family 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.
| Study group | Role | What they receive |
|---|---|---|
| Family Talk | Experimental | families will receive a manualized, family-based intervention Family Talk of approximately 8 sessions with a trained, Family Talk interventionist. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessment at baseline, 4 months and 12 months after baseline.
Secondary outcomes (4)
Change in Beck's Youth Inventories (BYI-II)
A 99 item self report measure consisting of 5 subscales to assess symptoms of Depression, Anxiety, Anger, Disruptive behaviour and Self-concept in children. Higher scores are associated with negative affect.
Measured: Assessment at baseline, 4 months and 12 months after baseline.
Change in Parent-Child Communication (Child-rated)
Questionnaire assessing communication between the child and the mentally ill parent. A 10 item questionnaire for children ages 8-12 and a 19 item questionnaire for children ages 13-17. Each item rated on a 6-point Likert scale. A higher score indicates better communication.
Measured: Assessment at baseline, 4 months and 12 months after baseline.
Change in Response to parents' mood
A 4-questions multiple-choice questionnaire administered to the child assessing the child's reaction to the parents' mood.
Measured: Assessment at baseline, 4 months and 12 months after baseline.
Change in parental recovery (Brief INSPIRE-O)
A 5 item self-report questionnaire completed by the parents assessing personal recovery. Each item rated on a score from 0-100. A higher score indicates better recovery.
Measured: Assessment at baseline, 4 months and 12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Aug 2020
- Primary completion31 Oct 2024
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, Sektion for Tværsektoriel forskning - Region Hovedstaden
- Responsible party
- Principal investigator, Anne Ranning, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Anne Ranning, PhD, Principal investigator, Mental Health Services in the Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615324
- Sponsor's protocol ID
- 127849
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37087437
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05615324
- Acronym / sponsor ID
- 127849
- Conditions
- Mental Disorder, Family, Child, Parenting, Resilience, Prevention
- Keywords
- Parental mental illness, COPMI, Intervention, Family Talk, Mental Illness, Beardslee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, Sektion for Tværsektoriel forskning - Region Hovedstaden
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family Talk | Experimental | Behavioral: Family Talk Preventive Interventionfamilies will receive a manualized, family-based intervention Family Talk of approximately 8 sessions with a trained, Family Talk interventionist. |
| 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not speaking Danish or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Talk Preventive InterventionAlso: Beardslee's Family InterventionThis 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. | Behavioural | Family Talk |
Primary outcome
Change in Children's Global Assessment Scale (CGAS)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
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.
Change in Family Assessment Device (FAD) (Parent-rated)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
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.
Change in Parenting Sense of Competency (PSOC)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
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.
4 secondary outcomes
Change in Beck's Youth Inventories (BYI-II)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
Change in Parent-Child Communication (Child-rated)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
Change in Response to parents' mood
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
Change in parental recovery (Brief INSPIRE-O)
Time frame: Assessment at baseline, 4 months and 12 months after baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 37087437Nielsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Ranning, PhD principal investigator
Mental Health Services in the Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Talk Preventive Intervention in people with Mental Disorder and Family, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Children's Global Assessment Scale (CGAS) (time frame: Assessment at baseline, 4 months and 12 months after baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.