Mental Health IssueNCT06163339
Evaluation of the Cultural Formulation Interview (CFI)
A study testing Cultural Formulation Interview in people with Mental Health Issue, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Studies show that the mental health of children may have deteriorated in recent decades. In Sweden, several national initiatives have been implemented to develop and strengthen interventions for children's mental health. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Cultural Formulation Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study Part
- Children between the ages of 6-14
- Families seeking care at any of the participating clinics
- Families assessed as suitable for interventions at the clinic where they seek care.
- Study Part 2
- Caregivers who have consented to participate in Part 1 and have been interviewed using CFI as part of the study
- Healthcare providers/personnel who have used CFI as part of Part 1.
Who cannot join
- Study Part 1
- Children who have not yet turned 6 years old and individuals aged 15 and above
- The child is assessed as not suitable for interventions at the clinic where they seek care.
- Study Part 2
- Caregivers who have not consented to participate in Part 1.
- Caregivers who have not been interviewed using CFI as part of the study.
- Healthcare providers/personnel who have not used CFI as part of Part 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cultural Formulation Interview (CFI) - An Interview Support Aiming to Enhance Assessment and Treatment Adherence
Studies show that the mental health of children may have deteriorated in recent decades. In Sweden, several national initiatives have been implemented to develop and strengthen interventions for children's mental health. One of these initiatives involves enhancing the first line of primary care for children with mental health issues, whose mission is to provide early intervention, i.e., support for mild to moderate mental health problems. The responsibility for children with moderate to severe mental health issues lies with child and adolescent psychiatry.
Research indicates that children with a migration background, to a lesser extent than native-born children, have contact with both the first line of mental health care and child and adolescent psychiatry. There is also research showing that when newly arrived individuals do seek care, they may receive poorer quality care than others and, for example, may be misunderstood. From the perspective of equal healthcare, this is a significant shortcoming. In our study, the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare.
In the study, the investigators aim to evaluate whether the Cultural Formulation Interview (CFI) improves the connection between healthcare providers and families and increases the family's involvement in treatment, ultimately leading to better mental health for the child. The method can be said to aim at enhancing the assessment, compliance, and treatment that are currently available within healthcare.
Read the detailed description
The overall aim of the project is is to evaluate the effects and experiences of the CFI, which aims to be a tool for assessing mental health regardless of cultural background. Developed by world-leading researchers in the field, CFI is intended to support psychiatric diagnosis, strengthen the alliance between healthcare providers and patients, and contribute to treatment planning that both parties agree on, thereby increasing adherence to treatment.
The specific research questions are:
Study Part 1 (Quantitative Method):
- Do caregivers, where the child undergoes an enhanced assessment with CFI (i.e., standard care + CFI), report better working alliance and treatment credibility compared to children receiving standard care?
- Do caregivers, where the child undergoes an enhanced assessment with CFI, report reduced mental health issues and increased quality of life compared to children receiving standard care?
Study Part 2 (Qualitative Method):
- How do caregivers experience the CFI interview questions and the assessment conversation with the healthcare provider?
- Do caregivers' gender and background factors (such as country of birth, migration experience, socioeconomic conditions, and occupation) influence their perception of CFI?
- How do caregivers perceive the child's reaction to CFI and the assessment conversation?
- How does CFI impact caregivers' understanding of healthcare and their sense of involvement?
- What is the staff's experience with CFI? (For example, regarding understanding the patient's difficulties, perspectives on illness, and socio-cultural context).
- How does CFI affect staff's interactions with patients and families?
- How do staff perceive the practical feasibility of CFI? (For example, in terms of time commitment and documentation).
- How do staff perceive that information from CFI influences the diagnosis, assessment, and treatment of healthcare needs?
CFI is developed by leading researchers in the field and is a tool intended to support psychiatric diagnosis, strengthen the alliance between healthcare providers and patients, and contribute to treatment planning that both parties agree on, thereby increasing adherence. The main interview consists of 16 open-ended questions that explore the patient's perspectives and context, including how social and cultural factors can influence expressions, explanatory models, coping strategies, and expectations of healthcare. The interview can be used by various professional categories such as physicians, psychologists, and counselors, and there is flexibility for healthcare providers to reformulate and choose questions they deem relevant for the assessment. The interview is intended for all patients but may be particularly useful in transcultural encounters. In addition to the main interview, there is also an interview targeting family members, as well as 12 in-depth supplementary modules. , one of which is designed for school-age children and adolescents and their parents.
Study Part 1 (Quantitative Method):
Healthcare providers (i.e., psychologists or counselors) at the participating clinics (Region Stockholm) will be randomly assigned to whether they will work with CFI during the study or not. Those working with CFI will receive training in the method before the study begins. Patients are referred to healthcare providers according to the clinic's procedures, often involving the provider with the shortest waiting time. To evaluate the effect of CFI on treatment credibility, working alliance with the healthcare provider, and the child's mental health, reliability and validity-tested rating scales will be used.
Study Part 2 (Qualitative Method):
Among the caregivers who participated in the assessment with CFI, some (approximately 10-15 individuals) will be interviewed, focusing on their experiences with CFI and their interactions with the clinic. Also, the staff who worked with CFI will be interviewed individually or in focus groups regarding their experience with CFI (n=5). These interviews (with caregivers and staff) will be conducted by members of the EPiCSS research group (Karolinska Institutet) using semi-structured interview guides based on themes. Interviews with caregivers and staff are offered on-site at the clinic or via phone or Zoom, conducted in Swedish or, if necessary, in English or through an interpreter.
Study Part 1 (Quantitative Method):
Within two-three weeks after the assessment interview (CFI interview or a corresponding visit in the control group), online survey data are collected regarding caregivers' confidence that the intervention their child will be offered at the clinic will help them (i.e., treatment credibility).
Three months after the CFI or corresponding visit, another online survey is sent to parents. The survey collects data on caregivers' experience of collaboration with the healthcare provider (i.e., working alliance) and caregivers' ratings of the child's mental health.
Study Part 2 (Qualitative Method):
Interviews about caregivers' experiences with CFI take place within three weeks after the caregiver has been interviewed with CFI. Interviews with staff occur at the earliest a couple of months after staff members start using CFI. The audio from interviews (both for caregivers and staff) regarding the experience of CFI is recorded.
- Conditions
- Mental Health Issue
- Being tested
- Cultural Formulation Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural Formulation InterviewOther
Also called CFI
Usual Care is enhanced with the Cultural Formulation Interview (CFI) aimed at strengthening assessment and treatment adherence
| Study group | Role | What they receive |
|---|---|---|
| CFI + Usual Care | Experimental | About half of participants who are allocated to a person who works with the CFI during the trial. Receives: Other: Cultural Formulation Interview |
| Usual Care | No intervention | About half of participants who are allocated to a person who do not work with the CFI during the trial (i.e., usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Credibility Scale
The scale includes four statements (for example, "So far, how well do you think this care seems to fit your problems?"). The informant can respond on a Likert scale ranging from 0 to 10.
Measured: Two-three weeks after the baseline assessment
Secondary outcomes (3)
KIDSCREEN-10
The scale aims to measure the child's well-being and includes 10 statements (for example, "Thinking about last week... did your child feel full of energy?"). The caregiver responds on a Likert scale with five options ranging from "Never" to "Always."
Measured: Three months after the baseline assessment
The Revised Child Anxiety and Depression Scale
The scale aims to jointly measure the child's anxiety and depression symptoms, and consists of 25 statements (for example, 'My child worries about things') where the caregiver responds on a Likert scale with four options ranging from 'Never' to 'Always. The sum of all 25 items represent a broad measure of internalized symptoms.
Measured: Three months after the baseline assessment
Working Alliance Inventory
The scale consists of six statements (for example, "Our therapist and we worked towards mutually agreed-upon goals") where the informant can respond using a Likert scale with six options ranging from "Not at all" to "Completely."
Measured: Three months after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dalman, Karolinska Institutet
- Investigators
- Christina Dalman, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163339
- Sponsor's protocol ID
- jaka01
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data may be shared, given that it is possible due to legislation in Sweden
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cultural Formulation Interview (CFI) - An Interview Support Aiming to Enhance Assessment and Treatment Adherence
- ClinicalTrials.gov ID
- NCT06163339
- Acronym / sponsor ID
- jaka01
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Dec 2023 (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.
Studies show that the mental health of children may have deteriorated in recent decades. In Sweden, several national initiatives have been implemented to develop and strengthen interventions for children's mental health. One of these initiatives involves enhancing the first line of primary care for children with mental health issues, whose mission is to provide early intervention, i.e., support for mild to moderate mental health problems. The responsibility for children with moderate to severe mental health issues lies with child and adolescent psychiatry.
Research indicates that children with a migration background, to a lesser extent than native-born children, have contact with both the first line of mental health care and child and adolescent psychiatry. There is also research showing that when newly arrived individuals do seek care, they may receive poorer quality care than others and, for example, may be misunderstood. From the perspective of equal healthcare, this is a significant shortcoming. In our study, the investigators address differences between healthcare providers and families based on cultural factors as a possible reason for the lack of equality in healthcare.
In the study, the investigators aim to evaluate whether the Cultural Formulation Interview (CFI) improves the connection between healthcare providers and families and increases the family's involvement in treatment, ultimately leading to better mental health for the child. The method can be said to aim at enhancing the assessment, compliance, and treatment that are currently available within healthcare.
Detailed description
The overall aim of the project is is to evaluate the effects and experiences of the CFI, which aims to be a tool for assessing mental health regardless of cultural background. Developed by world-leading researchers in the field, CFI is intended to support psychiatric diagnosis, strengthen the alliance between healthcare providers and patients, and contribute to treatment planning that both parties agree on, thereby increasing adherence to treatment.
The specific research questions are:
Study Part 1 (Quantitative Method):
- Do caregivers, where the child undergoes an enhanced assessment with CFI (i.e., standard care + CFI), report better working alliance and treatment credibility compared to children receiving standard care?
- Do caregivers, where the child undergoes an enhanced assessment with CFI, report reduced mental health issues and increased quality of life compared to children receiving standard care?
Study Part 2 (Qualitative Method):
- How do caregivers experience the CFI interview questions and the assessment conversation with the healthcare provider?
- Do caregivers' gender and background factors (such as country of birth, migration experience, socioeconomic conditions, and occupation) influence their perception of CFI?
- How do caregivers perceive the child's reaction to CFI and the assessment conversation?
- How does CFI impact caregivers' understanding of healthcare and their sense of involvement?
- What is the staff's experience with CFI? (For example, regarding understanding the patient's difficulties, perspectives on illness, and socio-cultural context).
- How does CFI affect staff's interactions with patients and families?
- How do staff perceive the practical feasibility of CFI? (For example, in terms of time commitment and documentation).
- How do staff perceive that information from CFI influences the diagnosis, assessment, and treatment of healthcare needs?
CFI is developed by leading researchers in the field and is a tool intended to support psychiatric diagnosis, strengthen the alliance between healthcare providers and patients, and contribute to treatment planning that both parties agree on, thereby increasing adherence. The main interview consists of 16 open-ended questions that explore the patient's perspectives and context, including how social and cultural factors can influence expressions, explanatory models, coping strategies, and expectations of healthcare. The interview can be used by various professional categories such as physicians, psychologists, and counselors, and there is flexibility for healthcare providers to reformulate and choose questions they deem relevant for the assessment. The interview is intended for all patients but may be particularly useful in transcultural encounters. In addition to the main interview, there is also an interview targeting family members, as well as 12 in-depth supplementary modules. , one of which is designed for school-age children and adolescents and their parents.
Study Part 1 (Quantitative Method):
Healthcare providers (i.e., psychologists or counselors) at the participating clinics (Region Stockholm) will be randomly assigned to whether they will work with CFI during the study or not. Those working with CFI will receive training in the method before the study begins. Patients are referred to healthcare providers according to the clinic's procedures, often involving the provider with the shortest waiting time. To evaluate the effect of CFI on treatment credibility, working alliance with the healthcare provider, and the child's mental health, reliability and validity-tested rating scales will be used.
Study Part 2 (Qualitative Method):
Among the caregivers who participated in the assessment with CFI, some (approximately 10-15 individuals) will be interviewed, focusing on their experiences with CFI and their interactions with the clinic. Also, the staff who worked with CFI will be interviewed individually or in focus groups regarding their experience with CFI (n=5). These interviews (with caregivers and staff) will be conducted by members of the EPiCSS research group (Karolinska Institutet) using semi-structured interview guides based on themes. Interviews with caregivers and staff are offered on-site at the clinic or via phone or Zoom, conducted in Swedish or, if necessary, in English or through an interpreter.
Study Part 1 (Quantitative Method):
Within two-three weeks after the assessment interview (CFI interview or a corresponding visit in the control group), online survey data are collected regarding caregivers' confidence that the intervention their child will be offered at the clinic will help them (i.e., treatment credibility).
Three months after the CFI or corresponding visit, another online survey is sent to parents. The survey collects data on caregivers' experience of collaboration with the healthcare provider (i.e., working alliance) and caregivers' ratings of the child's mental health.
Study Part 2 (Qualitative Method):
Interviews about caregivers' experiences with CFI take place within three weeks after the caregiver has been interviewed with CFI. Interviews with staff occur at the earliest a couple of months after staff members start using CFI. The audio from interviews (both for caregivers and staff) regarding the experience of CFI is recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFI + Usual Care | Experimental | Other: Cultural Formulation InterviewAbout half of participants who are allocated to a person who works with the CFI during the trial. |
| Usual Care | No intervention | –About half of participants who are allocated to a person who do not work with the CFI during the trial (i.e., usual care). |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Study Part
- Children between the ages of 6-14
- Families seeking care at any of the participating clinics
- Families assessed as suitable for interventions at the clinic where they seek care.
- Study Part 2
Key exclusion criteria (7 listed)
- Study Part 1
- Children who have not yet turned 6 years old and individuals aged 15 and above
- The child is assessed as not suitable for interventions at the clinic where they seek care.
- Study Part 2
- Caregivers who have not consented to participate in Part 1.
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 |
|---|---|---|
| Cultural Formulation InterviewAlso: CFIUsual Care is enhanced with the Cultural Formulation Interview (CFI) aimed at strengthening assessment and treatment adherence | Other | CFI + Usual Care |
Primary outcome
Treatment Credibility Scale
Time frame: Two-three weeks after the baseline assessment
The scale includes four statements (for example, "So far, how well do you think this care seems to fit your problems?"). The informant can respond on a Likert scale ranging from 0 to 10.
3 secondary outcomes
KIDSCREEN-10
Time frame: Three months after the baseline assessment
The Revised Child Anxiety and Depression Scale
Time frame: Three months after the baseline assessment
Working Alliance Inventory
Time frame: Three months after the baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided. Individual Participant Data may be shared, given that it is possible due to legislation in Sweden
Related trials for Mental Health Issue
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Family Spirit Strengths
Depressive Symptoms, Anxiety Disorders and Symptoms
RecruitingObservational study
Proximal Risk for Suicide in Adolescents
Suicide, Mental Health Issue
Recruiting
Striving Towards EmPowerment and Medication Adherence R01
Hiv, Mental Health Issue
Active, not recruiting
Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
Mental Health Issue
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.
Christina Dalman, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultural Formulation Interview in people with Mental Health Issue, run by Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Åhlén, PhD (+46768865446, johan.ahlen@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Credibility Scale (time frame: Two-three weeks after the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2023; AzTrials last refreshed its copy on 2 Nov 2026.