Evaluation of the Cultural Formulation Interview (CFI)

NCT06163339 | Unknown

• 1 other identifier: jaka01
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• 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.

  Two-three weeks after the baseline assessment

Secondary Outcomes (3)

• KIDSCREEN-10

  Three months after the baseline assessment

• The Revised Child Anxiety and Depression Scale

  Three months after the baseline assessment

• Working Alliance Inventory

  Three months after the baseline assessment

Study Arms (2)

CFI + Usual Care

EXPERIMENTAL

About half of participants who are allocated to a person who works with the CFI during the trial.

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).

Interventions

Cultural Formulation Interview OTHER

Usual Care is enhanced with the Cultural Formulation Interview (CFI) aimed at strengthening assessment and treatment adherence

Also known as: CFI

CFI + Usual Care

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, 171 65, Sweden

Location

MeSH Terms

Interventions

chemotactic factor inactivator

Study Officials

• Christina Dalman, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Åhlén, PhD

CONTACT

+46768865446; johan.ahlen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11

Locations

SE (1)