Adolescent Interpersonal Counseling in Primary Care

NCT06390462 | Recruiting DMC

• 1 other identifier: 1271/6.02.03/2024
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 4

Brief Summary

The demand for prevention and treatment of adolescent depression has rapidly increased over years. A national project to improve treatment of adolescent depression in primary care has taken place in Finland starting 2020. The goal of this prospective observational cohort study is to describe pathways to mental health services in adolescents with depressive symptoms. The main questions it aims to answer are:

• Do young people reporting depressive symptoms have equal access to treatment?
• How is it best to recognize those adolescents who will benefit from IPC-A? Adolescents who participate in the study will
• complete a survey on protective and risk factors of depression three times over 6 months
• report possible depressive symptoms every two weeks over 6 months
• report whether they needed and received help, motivation for treatment, and benefits and harms from treatment We will also collect
• information from one of caretakers with two surveys within 6 month- intervals on their view on adolescent's need for support, strengths and risks, and benefits and harms from treatment where applicable
• where applicable, from the professional who provided support after the intervention on their training and competence, as well as content of and response to treatment
• register data to estimate overall provision and cost of social welfare and health care services one year preceding the study and over 2 to 10 years after the observation period Researchers will compare an intervention that is new in Finland, adolescent interpersonal counseling (IPC-A), to other treatments of depression, to see if it is equal to or better than other treatments of depression.

Conditions

Depressive Symptoms Mild to Moderate in Severity; Major Depressive Disorder

Keywords

adolescent; depression; prospective; cohort study; interpersonal counseling; prevention; therapy; effectiveness; cost-effectiveness; predictor; economic evaluation

Outcome Measures

Primary Outcomes (1)

• Proportion of adolescents referred to specialized psychiatric services

  Proportion of adolescents in each three groups with sustained depressive symptoms by 6 months who receive specialized psychiatric services by 12 months

  From baseline to 12 months

Secondary Outcomes (2)

• Proportion of adolescents who received any social welfare or health care services

  Up to 10 years after baseline

• longitudinal changes in PHQ-9-A score

  2 weeks

Other Outcomes (8)

• Loneliness

  No time frame

• Experiences of Social Inclusion Scale

  No time frame

• The child-friendly EuroQol-5 dimensions questionnaire

  The same day

Study Arms (1)

Adolescents with sustained depression

PHQ-9-A ≥ 10 at least twice in a 6 months follow-up

Behavioral: Interpersonal counseling; Behavioral: Treatment as usual; Other: No support, intervention or other treatment

Interventions

Interpersonal counseling BEHAVIORAL

A structured psychotherapeutic intervention to prevent depression or treat mild to moderate depression. IPC-A is a brief, individual-based intervention (3-8 sessions). The focus is on interpersonal relations as a factor of resilience in depressive symptoms. IPC-A is a shorter form of IPT-A, developed by prof. Myrna Weissman and team.

Adolescents with sustained depression

Treatment as usual BEHAVIORAL

Any other behavioral or medical support or depression indicated by depressive symptoms or depression. This is based on adolescent, caretaker and professional's report.

Adolescents with sustained depression

No support, intervention or other treatment OTHER

The group will comprise those adolescents who report sustained depression but do not seek or receive support over 6 months of follow-up based on adolescent and caretaker's report

Adolescents with sustained depression

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents attending grades 7 to 9 (13 to 16 years) in selected schools

You may qualify if:

• we will include all adolescents attending grades 7 to 9 in selected schools with on informed consent

You may not qualify if:

• psychiatric care within the past 12 months or receiving a psychosocial intervention (psychotherapy, IPC-A, any other therapy of support) during the 12 months before baseline,
• an inability to reliably understand the Finnish, Plain Finnish, Swedish, or English versions of the survey, or

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• Strategic Research Council of Finland: collaborator
• University of Helsinki: collaborator
• University of Eastern Finland: collaborator
• Tampere University: collaborator

Study Sites (4)

The wellbeing services county of Kanta-Häme

Hämeenlinna, Finland

RECRUITING

Finnish Institute for Health and Welfare

Helsinki, 02710, Finland

RECRUITING

The wellbeing services county of Central Finland

Jyväskylä, Finland

RECRUITING

The wellbeing services county of North Ostrobothnia

Oulu, Finland

RECRUITING

Related Links

• Description in Finnish and in English about the study, participant informed consent (adolescent, caretaker, professional)

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Therapeutics; Methods

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Outi Linnaranta, MD, PhD

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Outi Linnaranta, MD, PhD

CONTACT

+358504327128; outi.linnaranta@thl.fi

Jasmin Kaljadin, MSc

CONTACT

+358295247728; jasmin.kaljadin@thl.fi

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 30, 2024
• Study Start: March 25, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2039
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: First baseline IPD available from fall 2025 for 10 years, final economic evaluation data will be stored from 2039 for 10 years
• Access Criteria: Data access is restricted by user roles with permission of PI (Outi Linnaranta), and all data will be pseudonymized. Sensitive register data including person IDs will be managed using the Findata Kapseli service.

Locations

FI (4)